76 FR 28689 - Microbiology Devices; Classification of In Vitro Diagnostic Device for Bacillus Species Detection

Science.gov (United States)

2011-05-18

.... FDA-2011-N-0103] Microbiology Devices; Classification of In Vitro Diagnostic Device for Bacillus... of the Microbiology Devices Advisory Panel (the Panel). In addition, the proposed rule would... in the Federal Register. 1. Transcript of the FDA Microbiology Devices Panel meeting, March 7, 2002...

76 FR 69034 - Microbiology Devices; Classification of In Vitro Diagnostic Device for Yersinia Species Detection

Science.gov (United States)

2011-11-07

... Drug Administration 21 CFR Part 866 Microbiology Devices; Classification of In Vitro Diagnostic Device... CFR Part 866 [Docket No. FDA-2011-N-0729] Microbiology Devices; Classification of In Vitro Diagnostic... of the Microbiology Devices Advisory Panel (the panel). FDA is publishing in this document the...

FDA publishes checklist of Y2K high-risk devices.

Science.gov (United States)

1999-09-01

Key points. The federal Food and Drug Administration (FDA) has developed a list of types of medical devices that have the potential for the most serious consequences for patients should they fail because of Y2K-related problems. This list of computer-controlled potentially high-risk devices can provide a guide to health care facilities regarding the types of devices that should receive priority in their assessment and remediation of medical devices. The list may change as the FDA receives comments on the types of devices included in the list.

42 CFR 405.203 - FDA categorization of investigational devices.

Science.gov (United States)

2010-10-01

... 42 Public Health 2 2010-10-01 2010-10-01 false FDA categorization of investigational devices. 405... Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational.../investigational (Category A) or non-experimental/investigational (Category B). (c) CMS uses the categorization of...

TU-AB-204-00: CDRH/FDA Regulatory Processes and Device Science Activities

International Nuclear Information System (INIS)

2016-01-01

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC

TU-AB-204-00: CDRH/FDA Regulatory Processes and Device Science Activities

Energy Technology Data Exchange (ETDEWEB)

NONE

2016-06-15

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC

78 FR 29672 - Cardiovascular Devices; Reclassification of External Counter-Pulsating Devices for Treatment of...

Science.gov (United States)

2013-05-21

.... FDA-2013-N-0487] Cardiovascular Devices; Reclassification of External Counter- Pulsating Devices for... proposed rule (44 FR 13426, March 9, 1979), the Cardiovascular Device Classification Panel (the 1979 Panel... of Subjects in 21 CFR Part 870 Medical devices, Cardiovascular devices...

High-risk medical devices, children and the FDA: regulatory challenges facing pediatric mechanical circulatory support devices.

Science.gov (United States)

Almond, Christopher S D; Chen, Eric A; Berman, Michael R; Less, Joanne R; Baldwin, J Timothy; Linde-Feucht, Sarah R; Hoke, Tracey R; Pearson, Gail D; Jenkins, Kathy; Duncan, Brian W; Zuckerman, Bram D

2007-01-01

Pediatric mechanical circulatory support is a critical unmet need in the United States. Infant- and child-sized ventricular assist devices are currently being developed largely through federal contracts and grants through the National Heart, Lung, and Blood Institute (NHLBI). Human testing and marketing of high-risk devices for children raises epidemiologic and regulatory issues that will need to be addressed. Leaders from the US Food and Drug Administration (FDA), NHLBI, academic pediatric community, and industry convened in January 2006 for the first FDA Workshop on the Regulatory Process for Pediatric Mechanical Circulatory Support Devices. The purpose was to provide the pediatric community with an overview of the federal regulatory process for high-risk medical devices and to review the challenges specific to the development and regulation of pediatric mechanical circulatory support devices. Pediatric mechanical circulatory support present significant epidemiologic, logistic, and financial challenges to industry, federal regulators, and the pediatric community. Early interactions with the FDA, shared appreciation of challenges, and careful planning will be critical to avoid unnecessary delays in making potentially life-saving devices available for children. Collaborative efforts to address these challenges are warranted.

Medicare covers the majority of FDA-approved devices and Part B drugs, but restrictions and discrepancies remain.

Science.gov (United States)

Chambers, James D; May, Katherine E; Neumann, Peter J

2013-06-01

The Food and Drug Administration (FDA) and Medicare use different standards to determine, first, whether a new drug or medical device can be marketed to the public and, second, if the federal health insurance program will pay for use of the drug or device. This discrepancy creates hurdles and uncertainty for drug and device manufacturers. We analyzed discrepancies between FDA approval and Medicare national coverage determinations for sixty-nine devices and Part B drugs approved during 1999-2011. We found that Medicare covered FDA-approved drugs or devices 80 percent of the time. However, Medicare often added conditions beyond FDA approval, particularly for devices and most often restricting coverage to patients with the most severe disease. In some instances, Medicare was less restrictive than the FDA. Our findings highlight the importance for drug and device makers of anticipating Medicare's needs when conducting clinical studies to support their products. Our findings also provide important insights for the FDA's and Medicare's pilot parallel review program.

Solar panel foundation device

Energy Technology Data Exchange (ETDEWEB)

Hawley, W.W.

1983-03-29

A transportable solar panel foundation device which has a bottom member, at least one upstanding side member, and an essentially open top. The side members are angled to permit nesting of a plurality of the foundation devices, and reinforcement pads are carried by the foundation device to support legs for one or more solar panels.

78 FR 9010 - Dental Devices; Reclassification of Temporary Mandibular Condyle Prosthesis

Science.gov (United States)

2013-02-07

.... FDA-2012-N-1239] Dental Devices; Reclassification of Temporary Mandibular Condyle Prosthesis AGENCY... condyle prostheses into class III, based on the recommendation of a Dental Products Panel (the Panel... Administration, Dental Products Advisory Panel Meeting Transcript, February 12, 1997; http://www.accessdata.fda...

FDA & digital mammography: why has FDA required full field digital mammography systems to be regulated as potentially dangerous devices for more than 10 years?

Science.gov (United States)

Nields, Morgan W

2010-05-01

Digital mammography is routinely used in the US to screen asymptomatic women for breast cancer and currently over 50% of US screening centers employ the technology. In spite of FDAs knowledge that digital mammography requires less radiation than film mammography and that its equivalence has been proven in a prospective randomized trial, the agency has failed to allow the technology market access via the 510(k) pre market clearance pathway. As a result of the restrictive Pre Market Approval process, only four suppliers have received FDA approval. The resulting lack of a competitive market has kept costs high, restricted technological innovation, and impeded product improvements as a result of PMA requirements. Meanwhile, at least twelve companies are on the market in the EU and the resulting competitive market has lowered costs and provided increased technological choice. A cultural change with new leadership occurred in the early 90's at FDA. The historical culture at the Center for Devices and Radiological Health of collaboration and education gave way to one characterized by a lack of reliance on outside scientific expertise, tolerance of decision making by unqualified reviewers, and an emphasis on enforcement and punishment. Digital mammography fell victim to this cultural change and as a result major innovations like breast CT and computer aided detection technologies are also withheld from the market. The medical device law, currently under review by the Institute of Medicine, should be amended by the Congress so that new technologies can be appropriately classified in accordance with the risk based assessment classification system detailed in Chapter V of the Federal Food, Drug, and Cosmetic Act. A panel of scientific experts chartered by the NIH or IOM should determine the classification appropriate for new technologies that have no historical regulatory framework. This would be binding on FDA. Unless the law is changed we will likely again experience

77 FR 16126 - Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for Mycobacterium tuberculosis

Science.gov (United States)

2012-03-19

.... FDA-2012-N-0159] Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for... convened a meeting of the Microbiology Devices Panel of the Medical Devices Advisory Committee (Microbiology Devices Panel) on June 29, 2011 (Ref. 2). Although not a formal reclassification meeting, panel...

78 FR 36698 - Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for Mycobacterium tuberculosis

Science.gov (United States)

2013-06-19

.... FDA-2013-N-0544] Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for... workshop, FDA agreed to consider this issue further and subsequently convened a meeting of the Microbiology... Health After considering the information discussed by the Microbiology Devices Panel during the June 29...

Constructing the informatics and information technology foundations of a medical device evaluation system: a report from the FDA unique device identifier demonstration.

Science.gov (United States)

Drozda, Joseph P; Roach, James; Forsyth, Thomas; Helmering, Paul; Dummitt, Benjamin; Tcheng, James E

2018-02-01

The US Food and Drug Administration (FDA) has recognized the need to improve the tracking of medical device safety and performance, with implementation of Unique Device Identifiers (UDIs) in electronic health information as a key strategy. The FDA funded a demonstration by Mercy Health wherein prototype UDIs were incorporated into its electronic information systems. This report describes the demonstration's informatics architecture. Prototype UDIs for coronary stents were created and implemented across a series of information systems, resulting in UDI-associated data flow from manufacture through point of use to long-term follow-up, with barcode scanning linking clinical data with UDI-associated device attributes. A reference database containing device attributes and the UDI Research and Surveillance Database (UDIR) containing the linked clinical and device information were created, enabling longitudinal assessment of device performance. The demonstration included many stakeholders: multiple Mercy departments, manufacturers, health system partners, the FDA, professional societies, the National Cardiovascular Data Registry, and information system vendors. The resulting system of systems is described in detail, including entities, functions, linkage between the UDIR and proprietary systems using UDIs as the index key, data flow, roles and responsibilities of actors, and the UDIR data model. The demonstration provided proof of concept that UDIs can be incorporated into provider and enterprise electronic information systems and used as the index key to combine device and clinical data in a database useful for device evaluation. Keys to success and challenges to achieving this goal were identified. Fundamental informatics principles were central to accomplishing the system of systems model. © The Author 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com

Characteristics of Clinical Studies Used for US Food and Drug Administration Approval of High-Risk Medical Device Supplements.

Science.gov (United States)

Zheng, Sarah Y; Dhruva, Sanket S; Redberg, Rita F

2017-08-15

High-risk medical devices often undergo modifications, which are approved by the US Food and Drug Administration (FDA) through various kinds of premarket approval (PMA) supplements. There have been multiple high-profile recalls of devices approved as PMA supplements. To characterize the quality of the clinical studies and data (strength of evidence) used to support FDA approval of panel-track supplements (a type of PMA supplement pathway that is used for significant changes in a device or indication for use and always requires clinical data). Descriptive study of clinical studies supporting panel-track supplements approved by the FDA between April 19, 2006, and October 9, 2015. Panel-track supplement approval. Methodological quality of studies including randomization, blinding, type of controls, clinical vs surrogate primary end points, use of post hoc analyses, and reporting of age and sex. Eighty-three clinical studies supported the approval of 78 panel-track supplements, with 71 panel-track supplements (91%) supported by a single study. Of the 83 studies, 37 (45%) were randomized clinical trials and 25 (30%) were blinded. The median number of patients per study was 185 (interquartile range, 75-305), and the median follow-up duration was 180 days (interquartile range, 84-270 days). There were a total of 150 primary end points (mean [SD], 1.8 [1.2] per study), and 57 primary end points (38%) were compared with controls. Of primary end points with controls, 6 (11%) were retrospective controls and 51 (89%) were active controls. One hundred twenty-one primary end points (81%) were surrogate end points. Thirty-three studies (40%) did not report age and 25 (30%) did not report sex for all enrolled patients. The FDA required postapproval studies for 29 of 78 (37%) panel-track supplements. Among clinical studies used to support FDA approval of high-risk medical device modifications, fewer than half were randomized, blinded, or controlled, and most primary outcomes were

75 FR 57968 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of...

Science.gov (United States)

2010-09-23

...] Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory... committee will discuss, make recommendations, and vote on information related to the PMA for the LAP-BAND...

78 FR 21129 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of...

Science.gov (United States)

2013-04-09

... radiofrequency band ranging between 13 megahertz to 27.12 megahertz and is intended for the treatment of medical...] Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices...

Software-Related Recalls of Health Information Technology and Other Medical Devices: Implications for FDA Regulation of Digital Health.

Science.gov (United States)

Ronquillo, Jay G; Zuckerman, Diana M

2017-09-01

Policy Points: Medical software has become an increasingly critical component of health care, yet the regulation of these devices is inconsistent and controversial. No studies of medical devices and software assess the impact on patient safety of the FDA's current regulatory safeguards and new legislative changes to those standards. Our analysis quantifies the impact of software problems in regulated medical devices and indicates that current regulations are necessary but not sufficient for ensuring patient safety by identifying and eliminating dangerous defects in software currently on the market. New legislative changes will further deregulate health IT, reducing safeguards that facilitate the reporting and timely recall of flawed medical software that could harm patients. Medical software has become an increasingly critical component of health care, yet the regulatory landscape for digital health is inconsistent and controversial. To understand which policies might best protect patients, we examined the impact of the US Food and Drug Administration's (FDA's) regulatory safeguards on software-related technologies in recent years and the implications for newly passed legislative changes in regulatory policy. Using FDA databases, we identified all medical devices that were recalled from 2011 through 2015 primarily because of software defects. We counted all software-related recalls for each FDA risk category and evaluated each high-risk and moderate-risk recall of electronic medical records to determine the manufacturer, device classification, submission type, number of units, and product details. A total of 627 software devices (1.4 million units) were subject to recalls, with 12 of these devices (190,596 units) subject to the highest-risk recalls. Eleven of the devices recalled as high risk had entered the market through the FDA review process that does not require evidence of safety or effectiveness, and one device was completely exempt from regulatory review

Towards a Computational Analysis of Status and Leadership Styles on FDA Panels

Science.gov (United States)

Broniatowski, David A.; Magee, Christopher L.

Decisions by committees of technical experts are increasingly impacting society. These decision-makers are typically embedded within a web of social relations. Taken as a whole, these relations define an implicit social structure which can influence the decision outcome. Aspects of this structure are founded on interpersonal affinity between parties to the negotiation, on assigned roles, and on the recognition of status characteristics, such as relevant domain expertise. This paper build upon a methodology aimed at extracting an explicit representation of such social structures using meeting transcripts as a data source. Whereas earlier results demonstrated that the method presented here can identify groups of decision-makers with a contextual affinity (i.e., membership in a given medical specialty or voting clique), we now can extract meaningful status hierarchies, and can identify differing facilitation styles among committee chairs. Use of this method is demonstrated on the transcripts of U.S. Food and Drug Administration (FDA) advisory panel meeting transcripts; nevertheless, the approach presented here is extensible to other domains and requires only a meeting transcript as input.

Medical devices: reports of corrections and removals; delay of effective data--FDA. Direct final rule; delay of effective date.

Science.gov (United States)

1998-11-18

The Food and Drug Administration (FDA) published in the Federal Register of August 7, 1998 (63 FR 42229), a direct final rule. The direct final rule notified the public of FDA's intention to amend the regulations that govern reports of corrections and removals of medical devices to eliminate the requirement for distributors to make such reports. This document delays the effective date of the direct final rule.

FDA (Food and Drug Administration) Compliance Program Guidance Manual (FY 88). Section 4. Medical and radiological devices

International Nuclear Information System (INIS)

1988-01-01

The FDA Compliance Program Guidance Manual provides a system for issuing and filing program plans and instructions directed to Food and Drug Administration Field operations for project implementation. Section IV provides those chapters of the Compliance Program Guidance Manual which pertain to the areas of medical and radiological devices. Some of the areas of coverage include laser and sunlamp standards inspections, compliance testing of various radiation-emitting products such as television receivers and microwave ovens, emergency response planning and policy, premarket approval and device manufacturers inspections, device problem reporting, sterilization of devices, and consumer education programs on medical and radiological devices

Re-Active Passive devices for control of noise transmission through a panel

Science.gov (United States)

Carneal, James P.; Giovanardi, Marco; Fuller, Chris R.; Palumbo, Dan

2008-01-01

Re-Active Passive devices have been developed to control low-frequency (transmission through a panel. These devices use a combination of active, re-active, and passive technologies packaged into a single unit to control a broad frequency range utilizing the strength of each technology over its best suited frequency range. The Re-Active Passive device uses passive constrained layer damping to cover relatively high-frequency range (>150 Hz), reactive distributed vibration absorber to cover the medium-frequency range (50-200 Hz), and active control for controlling low frequencies (transmission through a panel mounted in the Transmission Loss Test Facility at Virginia Tech. Experimental results are presented for the bare panel, and combinations of passive treatment, reactive treatment, and active control. Results indicate that three Re-Active Passive devices were able to increase the overall broadband (15-1000 Hz) transmission loss by 9.4 dB. These three devices added a total of 285 g to the panel mass of 6.0 kg, or approximately 5%, not including control electronics.

76 FR 41506 - Draft Guidance for Industry and FDA Staff on In Vitro Companion Diagnostic Devices; Availability

Science.gov (United States)

2011-07-14

...., Bldg. 51, rm. 2201, Silver Spring, MD 20993- 0002, or Office of Communication, Outreach and Development... help make critical treatment decisions. FDA oversight of companion diagnostics will protect patients... current thinking on companion diagnostic devices. It does not create or confer any rights for or on any...

Re-active Passive (RAP) Devices for Control of Noise Transmission through a Panel

Science.gov (United States)

Carneal, James P.; Giovanardi, Marco; Fuller, Chris R.; Palumbo, Daniel L.

2008-01-01

Re-Active Passive (RAP) devices have been developed to control low frequency (transmission through a panel. These devices use a combination of active, re-active, and passive technologies packaged into a single unit to control a broad frequency range utilizing the strength of each technology over its best suited frequency range. The RAP device uses passive constrained layer damping to cover the relatively high frequency range (>200 Hz), reactive distributed vibration absorber) to cover the medium frequency range (75 to 250 Hz), and active control for controlling low frequencies (transmission through a panel mounted in a transmission loss test facility. Experimental results are presented for the bare panel, and combinations of passive treatment, reactive treatment, and active control. Results indicate that three RAP devices were able to increase the overall broadband (15-1000 Hz) transmission loss by 9.4 dB. These three devices added a total of 285 grams to the panel mass of 6.0 kg, or approximately 5%, not including control electronics.

Drugs@FDA: FDA Approved Drug Products

Science.gov (United States)

... Cosmetics Tobacco Products Home Drug Databases Drugs@FDA Drugs@FDA: FDA Approved Drug Products Share Tweet Linkedin Pin it More sharing ... Download Drugs@FDA Express for free Search by Drug Name, Active Ingredient, or Application Number Enter at ...

76 FR 18227 - Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of...

Science.gov (United States)

2011-04-01

...] Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of Meeting... comment period for the notice announcing a meeting of the Molecular and Clinical Genetics Panel (the panel... Clinical Genetics Panel of the Medical Devices Advisory Committee, and the opening of a public docket to...

A History of the Sonocare CST-100: The First FDA-approved HIFU Device

Science.gov (United States)

Muratore, Robert

2006-05-01

The Sonocare CST-100 Therapeutic Ultrasound System, designed for the treatment of glaucoma, was developed in the 1980s and became the first high intensity focused ultrasound (HIFU) device to receive Food and Drug Administration approval. The system arose from studies done by F.L. Lizzi, Eng.Sc.D., of Riverside Research Institute and D.J. Coleman, M.D., of Cornell Medical Center/New York Hospital on the safety of ultrasound diagnosis of the eye. As safety limits were probed, therapeutic regimes were discovered. Optimization of operational parameters, clinical experience, and engineering design came together through a spin-off company, Sonocare, Inc., formed to produce and market the ophthalmic device. Various precedents were set during the approval process, including the acceptance by the FDA of radiation momentum imparted to an absorber as a measure of acoustic power. Many devices were sold, but the laser industry, grandfathered into the therapeutic field, eventually out-marketed Sonocare. The CST-100 remains as a model of elegant industrial design, and existing units are used daily in HIFU laboratory experiments.

78 FR 27971 - Dental Products Panel of the Medical Devices Advisory Committee; Notice of Meeting

Science.gov (United States)

2013-05-13

...] Dental Products Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Dental Products Panel of the Medical Devices Advisory Committee. General Function of the Committee: To... regulatory classification for dental devices known as Endosseous Dental Implants (Blade-form), one of the...

FDA (Food and Drug Administration) compliance program guidance manual and updates (FY 86). Section 4. Medical and radiological devices. Irregular report

International Nuclear Information System (INIS)

1986-01-01

The FDA Compliance Program Guidance Manual provides a system for issuing and filing program plans and instructions directed to Food and Drug Administration Field operations for project implementation. Section IV provides those chapters of the Compliance Program Guidance Manual which pertain to the areas of medical and radiological devices. Some of the areas of coverage include laser and sunlamp standards inspections, compliance testing of various radiation-emitting products such as television receivers and microwave ovens, emergency response planning and policy, premarket approval and device manufacturers inspections, device problem reporting, sterilization of devices, and consumer education programs on medical and radiological devices

Gaps, tensions, and conflicts in the FDA approval process: implications for clinical practice.

Science.gov (United States)

Deyo, Richard A

2004-01-01

Despite many successes, drug approval at the Food and Drug Administration (FDA) is subject to gaps, internal tensions, and conflicts of interest. Recalls of drugs and devices and studies demonstrating advantages of older drugs over newer ones highlight the importance of these limitations. The FDA does not compare competing drugs and rarely requires tests of clinical efficacy for new devices. It does not review advertisements before use, assess cost-effectiveness, or regulate surgery (except for devices). Many believe postmarketing surveillance of drugs and devices is inadequate. A source of tension within the agency is pressure for speedy approvals. This may have resulted in "burn-out" among medical officers and has prompted criticism that safety is ignored. Others argue, however, that the agency is unnecessarily slow and bureaucratic. Recent reports identify conflicts of interest (stock ownership, consulting fees, research grants) among some members of the FDA's advisory committees. FDA review serves a critical function, but physicians should be aware that new drugs may not be as effective as old ones; that new drugs are likely to have undiscovered side effects at the time of marketing; that direct-to-consumer ads are sometimes misleading; that new devices generally have less rigorous evidence of efficacy than new drugs; and that value for money is not considered in approval.

78 FR 68714 - Medical Devices; Ophthalmic Devices; Classification of the Scleral Plug

Science.gov (United States)

2013-11-15

... amendments), as ``preamendments devices.'' FDA classifies these devices after the Agency takes the following.... FDA-2012-N-1238] Medical Devices; Ophthalmic Devices; Classification of the Scleral Plug AGENCY: Food... scleral plugs in order to provide a reasonable assurance of safety and effectiveness of the device. The...

Network-Based Real-time Integrated Fire Detection and Alarm (FDA) System with Building Automation

Science.gov (United States)

Anwar, F.; Boby, R. I.; Rashid, M. M.; Alam, M. M.; Shaikh, Z.

2017-11-01

Fire alarm systems have become increasingly an important lifesaving technology in many aspects, such as applications to detect, monitor and control any fire hazard. A large sum of money is being spent annually to install and maintain the fire alarm systems in buildings to protect property and lives from the unexpected spread of fire. Several methods are already developed and it is improving on a daily basis to reduce the cost as well as increase quality. An integrated Fire Detection and Alarm (FDA) systems with building automation was studied, to reduce cost and improve their reliability by preventing false alarm. This work proposes an improved framework for FDA system to ensure a robust intelligent network of FDA control panels in real-time. A shortest path algorithmic was chosen for series of buildings connected by fiber optic network. The framework shares information and communicates with each fire alarm panels connected in peer to peer configuration and declare the network state using network address declaration from any building connected in network. The fiber-optic connection was proposed to reduce signal noises, thus increasing large area coverage, real-time communication and long-term safety. Based on this proposed method an experimental setup was designed and a prototype system was developed to validate the performance in practice. Also, the distributed network system was proposed to connect with an optional remote monitoring terminal panel to validate proposed network performance and ensure fire survivability where the information is sequentially transmitted. The proposed FDA system is different from traditional fire alarm and detection system in terms of topology as it manages group of buildings in an optimal and efficient manner.Introduction

Security and privacy qualities of medical devices: an analysis of FDA postmarket surveillance.

Science.gov (United States)

Kramer, Daniel B; Baker, Matthew; Ransford, Benjamin; Molina-Markham, Andres; Stewart, Quinn; Fu, Kevin; Reynolds, Matthew R

2012-01-01

Medical devices increasingly depend on computing functions such as wireless communication and Internet connectivity for software-based control of therapies and network-based transmission of patients' stored medical information. These computing capabilities introduce security and privacy risks, yet little is known about the prevalence of such risks within the clinical setting. We used three comprehensive, publicly available databases maintained by the Food and Drug Administration (FDA) to evaluate recalls and adverse events related to security and privacy risks of medical devices. Review of weekly enforcement reports identified 1,845 recalls; 605 (32.8%) of these included computers, 35 (1.9%) stored patient data, and 31 (1.7%) were capable of wireless communication. Searches of databases specific to recalls and adverse events identified only one event with a specific connection to security or privacy. Software-related recalls were relatively common, and most (81.8%) mentioned the possibility of upgrades, though only half of these provided specific instructions for the update mechanism. Our review of recalls and adverse events from federal government databases reveals sharp inconsistencies with databases at individual providers with respect to security and privacy risks. Recalls related to software may increase security risks because of unprotected update and correction mechanisms. To detect signals of security and privacy problems that adversely affect public health, federal postmarket surveillance strategies should rethink how to effectively and efficiently collect data on security and privacy problems in devices that increasingly depend on computing systems susceptible to malware.

Security and Privacy Qualities of Medical Devices: An Analysis of FDA Postmarket Surveillance

Science.gov (United States)

Kramer, Daniel B.; Baker, Matthew; Ransford, Benjamin; Molina-Markham, Andres; Stewart, Quinn; Fu, Kevin; Reynolds, Matthew R.

2012-01-01

Background Medical devices increasingly depend on computing functions such as wireless communication and Internet connectivity for software-based control of therapies and network-based transmission of patients’ stored medical information. These computing capabilities introduce security and privacy risks, yet little is known about the prevalence of such risks within the clinical setting. Methods We used three comprehensive, publicly available databases maintained by the Food and Drug Administration (FDA) to evaluate recalls and adverse events related to security and privacy risks of medical devices. Results Review of weekly enforcement reports identified 1,845 recalls; 605 (32.8%) of these included computers, 35 (1.9%) stored patient data, and 31 (1.7%) were capable of wireless communication. Searches of databases specific to recalls and adverse events identified only one event with a specific connection to security or privacy. Software-related recalls were relatively common, and most (81.8%) mentioned the possibility of upgrades, though only half of these provided specific instructions for the update mechanism. Conclusions Our review of recalls and adverse events from federal government databases reveals sharp inconsistencies with databases at individual providers with respect to security and privacy risks. Recalls related to software may increase security risks because of unprotected update and correction mechanisms. To detect signals of security and privacy problems that adversely affect public health, federal postmarket surveillance strategies should rethink how to effectively and efficiently collect data on security and privacy problems in devices that increasingly depend on computing systems susceptible to malware. PMID:22829874

Identifying and Synchronizing Health Information Technology (HIT) Events from FDA Medical Device Reports.

Science.gov (United States)

Kang, Hong; Wang, Frank; Zhou, Sicheng; Miao, Qi; Gong, Yang

2017-01-01

Health information technology (HIT) events, a subtype of patient safety events, pose a major threat and barrier toward a safer healthcare system. It is crucial to gain a better understanding of the nature of the errors and adverse events caused by current HIT systems. The scarcity of HIT event-exclusive databases and event reporting systems indicates the challenge of identifying the HIT events from existing resources. FDA Manufacturer and User Facility Device Experience (MAUDE) database is a potential resource for HIT events. However, the low proportion and the rapid evolvement of HIT-related events present challenges for distinguishing them from other equipment failures and hazards. We proposed a strategy to identify and synchronize HIT events from MAUDE by using a filter based on structured features and classifiers based on unstructured features. The strategy will help us develop and grow an HIT event-exclusive database, keeping pace with updates to MAUDE toward shared learning.

Extending FDA guidance to include consumer medication information (CMI) delivery on mobile devices.

Science.gov (United States)

Sage, Adam; Blalock, Susan J; Carpenter, Delesha

This paper describes the current state of consumer-focused mobile health application use and the current U.S. Food and Drug Administration (FDA) guidance on the distribution of consumer medication information (CMI), and discusses recommendations and considerations for the FDA to expand CMI guidance to include CMI in mobile applications. Smartphone-based health interventions have been linked to increased medication adherence and improved health outcomes. Trends in smartphone ownership present opportunities to more effectively communicate and disseminate medication information; however, current FDA guidance for CMI does not outline how to effectively communicate CMI on a mobile platform, particularly in regards to user-centered design and information sourcing. As evidence supporting the potential effectiveness of mobile communication in health care continues to increase, CMI developers, regulating entities, and researchers should take note. Although mobile-based CMI offers an innovative mechanism to deliver medication information, caution should be exercised. Specifically, considerations for developing mobile CMI include consumers' digital literacy, user experience (e.g., usability), and the quality and accuracy of new widely used sources of information (e.g., crowd-sourced reviews and ratings). Recommended changes to FDA guidance for CMI include altering the language about scientific accuracy to address more novel methods of information gathering (e.g., anecdotal experiences and Google Consumer Surveys) and including guidance for usability testing of mobile health applications. Copyright © 2016 Elsevier Inc. All rights reserved.

Bringing smart pills to market: FDA regulation of ingestible drug/device combination products.

Science.gov (United States)

Avery, Matthew; Liu, Dan

2011-01-01

Imagine a pill that, after you swallow it, can track its position in your body. Or imagine a pill that can transmit a message to a doctor to tell him that you have taken your bitter medicine. Pills like this already exist. These so-called smart pills are an emerging type of medical therapy. However, this nascent technology has yet to reach the market and developers of these novel therapies face significant regulatory challenges. This article predicts how the Food and Drug Administration will regulate smart pills and shows how the current regulatory regime is inadequate. The article then proposes modifying the current regulatory regime to encourage development of smart pills and other innovative combination products by: (1) regulating combination products based on their "novel mode of action" rather than their "primary mode of action," (2) creating a marketing approval pathway specifically for combination products, and (3) eliminating regulations that require sponsors to get marketing approval from multiple centers within FDA and providing regulatory guidance specifically for ingestible drug/device combination products.

No sisyphean task: how the FDA can regulate electronic cigarettes.

Science.gov (United States)

Paradise, Jordan

2013-01-01

The adverse effects of smoking have fostered a natural market for smoking cessation and smoking reduction products. Smokers attempting to quit or reduce consumption have tried everything: "low" or "light" cigarettes; nicotine-infused chewing gum, lozenges, and lollipops; dermal patches; and even hypnosis. The latest craze in the quest to find a safer source of nicotine is the electronic cigarette. Electronic cigarettes (e-cigarettes) have swept the market, reaching a rapidly expanding international consumer base. Boasting nicotine delivery and the tactile feel of a traditional cigarette without the dozens of other chemical constituents that contribute to carcinogenicity, e-cigarettes are often portrayed as less risky, as a smoking reduction or even a complete smoking cessation product, and perhaps most troubling for its appeal to youth, as a flavorful, trendy, and convenient accessory. The sensationalism associated with e-cigarettes has spurred outcry from health and medical professional groups, as well as the Food and Drug Administration (FDA), because of the unknown effects on public health. Inhabiting a realm of products deemed "tobacco products" under recent 2009 legislation, e-cigarettes pose new challenges to FDA regulation because of their novel method of nicotine delivery, various mechanical and electrical parts, and nearly nonexistent safety data. Consumer use, marketing and promotional claims, and technological characteristics of e-cigarettes have also raised decades old questions of when the FDA can assert authority over products as drugs or medical devices. Recent case law restricting FDA enforcement efforts against e-cigarettes further confounds the distinction among drugs and medical devices, emerging e-cigarette products, and traditional tobacco products such as cigarettes, cigars, and smokeless tobacco. This Article investigates the e-cigarette phenomenon in the wake of the recently enacted Family Smoking Prevention and Tobacco Control Act of 2009

Right to experimental treatment: FDA new drug approval, constitutional rights, and the public's health.

Science.gov (United States)

Leonard, Elizabeth Weeks

2009-01-01

On May 2, 2006, a divided panel of the U.S. Court of Appeals for the District of Columbia, in a startling opinion, Abigail Alliance for Better Access to Developmental Drugs v. Eschenbach, held that terminally ill patients who have exhausted all other available options have a constitutional right to experimental treatment that FDA has not yet approved. Although ultimately overturned by the full court, Abigail Alliance generated considerable interest from various constituencies. Meanwhile, FDA proposed similar regulatory amendments, as have lawmakers on both sides of the aisle in Congress. But proponents of expanded access fail to consider public health and consumer safety concerns. In particular, allowing patients to try unproven treatments, outside of controlled clinical trials risks both the study's outcome and the health of patients who might benefit from the deliberate, careful process of new drug approval as it currently operates under FDA's auspices.

Drugs@FDA Database

Data.gov (United States)

U.S. Department of Health & Human Services — Information about FDA-approved brand name and generic prescription and over-the-counter human drugs and biological therapeutic products. Drugs@FDA includes most of...

77 FR 42318 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of...

Science.gov (United States)

2012-07-18

... generally intended as an adjunct to fusion for the treatment of degenerative disc disease (as defined by..., infection, and inflammatory disorders in the cervical spine. FDA intends to make background material... accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the...

Process and a device for manufacturing a composite building panel for use in a building structure cladding system

Energy Technology Data Exchange (ETDEWEB)

Tetu, B

1991-06-11

A process and device are disclosed for manufacturing a composite panel used for cladding a building. The panel comprises a facing layer made from a plurality of facing elements, such as brick slices, retained in a spaced-apart relationship, and magnetically attractible particulate material disposed between the facing elements to imitate mortar. A rigid backing layer is provided, spaced from the spacing layer, and the space between the facing and the backing layers is filled with an insulation/bonding layer, made of urethane foam. The device for manufacturing the panel comprises a facing element holder in the form of a structure with a plurality of recesses for receiving facing elements, also including spacers between the recesses in order to retain the facing elements in a spaced-apart relationship. Ceramic magnets are provided on the spacers for temporarily retaining the particulate material against gravity until the insulation/bonding layer is built which retains all the panel elements together. The invention enables manufacture of non-planar panels, such as those used on corners of buildings, thereby eliminating the need for a corner joint. 9 figs.

78 FR 24426 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of...

Science.gov (United States)

2013-04-25

... on FDA's regulatory issues. Date and Time: The meeting will be held on July 24 and 25, 2013, from 8 a... confirmed by patient history, physical examination, and radiographic studies. FDA intends to make background... notify the contact person and submit a brief statement of the general nature of the evidence or arguments...

FDA, CE mark or something else?-Thinking fast and slow.

Science.gov (United States)

Mishra, Sundeep

There is a robust debate going on among the Medical Device stake-holders whether FDA is better or CE mark or something else. Currently process of obtaining an FDA approval is bogged down by ever-increasing unpredictability, inconsistency, prolonged time, and huge expense but CE mark has its own problems. Historically, the Japanese review process has tended to be the slowest among the big three but recently with the introduction of accelerated review process there has been a significant progress. While the goal of an innovator/manufacturer is to develop, manufacture and market a medical device that addresses an unmet clinical need, the requisite regulatory approval process can be very confusing. Not only there is a whole lot of jargon tossed around by regulatory affair professionals: "substantial equivalence," "PMDA," "CE mark," "Notified body," "510K" and "PMA" but the actual approval process can also be very tardy, inconsistent and expensive. Copyright © 2016 Cardiological Society of India. Published by Elsevier B.V. All rights reserved.

Regulating nanomedicine - can the FDA handle it?

Science.gov (United States)

Bawa, Raj

2011-05-01

There is enormous excitement and expectation surrounding the multidisciplinary field of nanomedicine - the application of nanotechnology to healthcare - which is already influencing the pharmaceutical industry. This is especially true in the design, formulation and delivery of therapeutics. Currently, nanomedicine is poised at a critical stage. However, regulatory guidance in this area is generally lacking and critically needed to provide clarity and legal certainty to manufacturers, policymakers, healthcare providers as well as public. There are hundreds, if not thousands, of nanoproducts on the market for human use but little is known of their health risks, safety data and toxicity profiles. Less is known of nanoproducts that are released into the environment and that come in contact with humans. These nanoproducts, whether they are a drug, device, biologic or combination of any of these, are creating challenges for the Food and Drug Administration (FDA), as regulators struggle to accumulate data and formulate testing criteria to ensure development of safe and efficacious nanoproducts (products incorporating nanoscale technologies). Evidence continues to mount that many nanoproducts inherently posses novel size-based properties and toxicity profiles. Yet, this scientific fact has been generally ignored by the FDA and the agency continues to adopt a precautionary approach to the issue in hopes of countering future potential negative public opinion. As a result, the FDA has simply maintained the status quo with regard to its regulatory policies pertaining to nanomedicine. Therefore, there are no specific laws or mechanisms in place for oversight of nanomedicine and the FDA continues to treat nanoproducts as substantially equivalent ("bioequivalent") to their bulk counterparts. So, for now nanoproducts submitted for FDA review will continue to be subjected to an uncertain regulatory pathway. Such regulatory uncertainty could negatively impact venture funding, stifle

Medical devices; exemption from premarket notification; class II devices; wheelchair elevator. Final order.

Science.gov (United States)

2013-03-04

The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from premarket notification requirements for wheelchair elevator devices commonly known as inclined platform lifts and vertical platform lifts. These devices are used to provide a means for a person with a mobility impairment caused by injury or other disease to move from one level to another, usually in a wheelchair. This order exempts wheelchair elevators, class II devices, from premarket notification and establishes conditions for exemption for this device that will provide a reasonable assurance of the safety and effectiveness of the device without submission of a premarket notification (510(k)). This exemption from 510(k), subject to these conditions, is immediately in effect for wheelchair elevators. All other devices classified under FDA's wheelchair elevator regulations, including attendant-operated stair climbing devices for wheelchairs and portable platform lifts, continue to require submission of 510(k)s. FDA is publishing this order in accordance with the section of the Food, Drug, and Cosmetic Act (the FD&C Act) permitting the exemption of a device from the requirement to submit a 510(k).

TU-AB-204-01: Device Approval Process

International Nuclear Information System (INIS)

Delfino, J.

2016-01-01

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC

TU-AB-204-01: Device Approval Process

Energy Technology Data Exchange (ETDEWEB)

Delfino, J. [Food & Drug Administration (United States)

2016-06-15

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC

FDA-CDC Antimicrobial Resistance Isolate Bank: a Publicly Available Resource To Support Research, Development, and Regulatory Requirements.

Science.gov (United States)

Lutgring, Joseph D; Machado, María-José; Benahmed, Faiza H; Conville, Patricia; Shawar, Ribhi M; Patel, Jean; Brown, Allison C

2018-02-01

The FDA-CDC Antimicrobial Resistance Isolate Bank was created in July 2015 as a publicly available resource to combat antimicrobial resistance. It is a curated repository of bacterial isolates with an assortment of clinically important resistance mechanisms that have been phenotypically and genotypically characterized. In the first 2 years of operation, the bank offered 14 panels comprising 496 unique isolates and had filled 486 orders from 394 institutions throughout the United States. New panels are being added. Copyright © 2018 American Society for Microbiology.

FDA publishes conflict of interest rules for clinical trials. Food and Drug Administration.

Science.gov (United States)

James, J S

1998-03-06

The Food and Drug Administration (FDA) published new rules defining conflict of interests between drug companies and medical researchers and clinicians. Certain financial arrangements will need to be disclosed, although the FDA estimates that only one to ten percent of pharmaceutical companies will need to submit disclosures for one or more of their investigators. The purpose of the new rule is to prevent bias in safety and efficacy studies of drugs and medical devices. The full rule is published in the Federal Register.

FDA regulation of tobacco: blessing or curse for FDA professionals?

Science.gov (United States)

O'Reilly, James T

2009-01-01

Upwards of 400,000 Americans will die that year from the effects of cigarettes, which FDA will now "regulate" very gently, with its hands tied by a slick statutory protection for the largest existing tobacco marketers. Career FDA professionals will be criticized as enablers of mega-marketers' continued sales, working at the margins, arranging the paperwork for protection of megafirms' market share, and sitting by as the deaths and addictive behaviors continue. "Join the Public Health Service, inspired by a public health mission," they were told, and yet they will be unable to do much regulating of the addictive and fatal products for which they now have titular responsibility. This essay observes that these fine FDA professionals are handed the sticky remains of a messy bargain, negotiated in a distracted Congress by expensive lawyers with clients who were potent contributors to political action committees. The only formula that is not secret about the 2009 law is the way in which industry purchased sufficient allegiance to gather the votes for its adoption. The remaining mystery is how FDA could be expected to do these tasks without losing its best and brightest professionals to other fields.

Analysis of 3-panel and 4-panel microscale ionization sources

International Nuclear Information System (INIS)

Natarajan, Srividya; Parker, Charles B.; Glass, Jeffrey T.; Piascik, Jeffrey R.; Gilchrist, Kristin H.; Stoner, Brian R.

2010-01-01

Two designs of a microscale electron ionization (EI) source are analyzed herein: a 3-panel design and a 4-panel design. Devices were fabricated using microelectromechanical systems technology. Field emission from carbon nanotube provided the electrons for the EI source. Ion currents were measured for helium, nitrogen, and xenon at pressures ranging from 10 -4 to 0.1 Torr. A comparison of the performance of both designs is presented. The 4-panel microion source showed a 10x improvement in performance compared to the 3-panel device. An analysis of the various factors affecting the performance of the microion sources is also presented. SIMION, an electron and ion optics software, was coupled with experimental measurements to analyze the ion current results. The electron current contributing to ionization and the ion collection efficiency are believed to be the primary factors responsible for the higher efficiency of the 4-panel microion source. Other improvements in device design that could lead to higher ion source efficiency in the future are also discussed. These microscale ion sources are expected to find application as stand alone ion sources as well as in miniature mass spectrometers.

FDA Acronyms and Abbreviations

Data.gov (United States)

U.S. Department of Health & Human Services — The FDA Acronyms and Abbreviations database provides a quick reference to acronyms and abbreviations related to Food and Drug Administration (FDA) activities

FDA, CE mark or something else?—Thinking fast and slow

Directory of Open Access Journals (Sweden)

Sundeep Mishra

2017-01-01

Full Text Available There is a robust debate going on among the Medical Device stake-holders whether FDA is better or CE mark or something else. Currently process of obtaining an FDA approval is bogged down by ever-increasing unpredictability, inconsistency, prolonged time, and huge expense but CE mark has its own problems. Historically, the Japanese review process has tended to be the slowest among the big three but recently with the introduction of accelerated review process there has been a significant progress. While the goal of an innovator/manufacturer is to develop, manufacture and market a medical device that addresses an unmet clinical need, the requisite regulatory approval process can be very confusing. Not only there is a whole lot of jargon tossed around by regulatory affair professionals: “substantial equivalence,” “PMDA,” “CE mark,” “Notified body,” “510K” and “PMA” but the actual approval process can also be very tardy, inconsistent and expensive.

Performance comparison between silicon solar panel and dye-sensitized solar panel in Malaysia

Science.gov (United States)

Hamed, N. K. A.; Ahmad, M. K.; Urus, N. S. T.; Mohamad, F.; Nafarizal, N.; Ahmad, N.; Soon, C. F.; Ameruddin, A. S.; Faridah, A. B.; Shimomura, M.; Murakami, K.

2017-09-01

In carrying out experimental research in performance between silicon solar panel and dye-sensitive solar panel, we have been developing a device and a system. This system has been developed consisting of controllers, hardware and software. This system is capable to get most of the input sources. If only need to change the main circuit and coding for a different source input value. This device is able to get the ambient temperature, surface temperature, surrounding humidity, voltage with load, current with load, voltage without load and current without load and save the data into external memory. This device is able to withstand the heat and rain as it was fabricated in a waterproof box. This experiment was conducted to examine the performance of both the solar panels which are capable to maintain their stability and performance. A conclusion based on data populated, the distribution of data for dye-sensitized solar panel is much better than silicon solar panel as dye-sensitized solar panel is very sensitive to heat and not depend only on midday where is that is the maximum ambient temperature for both solar panel as silicon solar panel only can give maximum and high output only when midday.

77 FR 14404 - Guidance for the Public, Food and Drug Administration (FDA) Advisory Committee Members, and FDA...

Science.gov (United States)

2012-03-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2002-D-0094; (formerly Docket No. 02D-0049)] Guidance for the Public, Food and Drug Administration (FDA) Advisory... Food and Drug Administration (FDA) is announcing the availability of a guidance for the public, FDA...

Preventing medical device recalls

CERN Document Server

Raheja, Dev

2014-01-01

Introduction to Medical Device RequirementsIntroductionThe ChallengesSources of ErrorsUnderstanding the Science of Safety     Overview of FDA Quality System Regulation     Overview of Risk Management Standard ISO 14971     Overview of FDA Device Approval Process     Overview of Regulatory Requirements for Clinical TrialsSummaryReferencesPreventing Recalls during Specification WritingIntroductionConduct Requirements Analysis to Identify Missing RequirementsSpecifications for Safety, Durability, and

TU-AB-204-02: Device Adverse Events and Compliance

International Nuclear Information System (INIS)

Gonzales, S.

2016-01-01

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC

TU-AB-204-02: Device Adverse Events and Compliance

Energy Technology Data Exchange (ETDEWEB)

Gonzales, S. [Food & Drug Administration (United States)

2016-06-15

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC

Scouting For Approval: Lessons on Medical Device Regulation in an Era of Crowdfunding from Scanadu's "Scout".

Science.gov (United States)

Smith, Colleen

2015-01-01

Internet crowdfunding, a new and increasingly popular method of raising capital to develop products and businesses, has recently come into conflict with the Food and Drug Administration's (FDA's) regulation of medical devices. This Article examines the issues that arise when companies pre-sell medical devices via crowdfunding campaigns before gaining FDA approval of the devices. Because Internet crowdfunding has only been in use for a few years, little has been written about it academically, particularly about its interaction with FDA regulations. The rising interest in crowdfunding, coupled with the downturn in investment in the American medical device industry, make this a salient issue that is ripe for FDA review. This Article uses the crowdfunding campaign Scanadu, a medical device company, conducted in 2013 to raise money to develop its in-home diagnostic device, the "Scout," as a starting point for this analysis. Because it is extremely costly to develop a device and obtain FDA approval, medical device companies should be able to utilize crowdfunding to raise the necessary capital. However, because of the possible dangers medical devices pose, FDA needs to review the risks created by allowing companies to crowdfund medical devices and should issue guidance to help companies comply with FDA regulations while still allowing them to take advantage of the benefits of crowdfunding. This guidance should ensure the continued commitment to consumer safety that is at the core of FDA regulation.

FDA Warns About Stem Cell Therapies

Science.gov (United States)

... Home For Consumers Consumer Updates FDA Warns About Stem Cell Therapies Share Tweet Linkedin Pin it More sharing ... see the boxed section below for more advice. Stem Cell Uses and FDA Regulation The FDA has the ...

Human Factors and Medical Devices

International Nuclear Information System (INIS)

Dick Sawyer

1998-01-01

Medical device hardware- and software-driven user interfaces should be designed to minimize the likelihood of use-related errors and their consequences. The role of design-induced errors in medical device incidents is attracting widespread attention. The U.S. Food and Drug Administration (FDA) is fully cognizant that human factors engineering is critical to the design of safe medical devices, and user interface design is receiving substantial attention by the agency. Companies are paying more attention to the impact of device design, including user instructions, upon the performance of those health professionals and lay users who operate medical devices. Concurrently, the FDA is monitoring human factors issues in its site inspections, premarket device approvals, and postmarket incident evaluations. Overall, the outlook for improved designs and safer device operation is bright

Syndromic Panel-Based Testing in Clinical Microbiology.

Science.gov (United States)

Ramanan, Poornima; Bryson, Alexandra L; Binnicker, Matthew J; Pritt, Bobbi S; Patel, Robin

2018-01-01

The recent development of commercial panel-based molecular diagnostics for the rapid detection of pathogens in positive blood culture bottles, respiratory specimens, stool, and cerebrospinal fluid has resulted in a paradigm shift in clinical microbiology and clinical practice. This review focuses on U.S. Food and Drug Administration (FDA)-approved/cleared multiplex molecular panels with more than five targets designed to assist in the diagnosis of bloodstream, respiratory tract, gastrointestinal, or central nervous system infections. While these panel-based assays have the clear advantages of a rapid turnaround time and the detection of a large number of microorganisms and promise to improve health care, they present certain challenges, including cost and the definition of ideal test utilization strategies (i.e., optimal ordering) and test interpretation. Copyright © 2017 American Society for Microbiology.

Effect of warning placement on the information processing of college students reading an OTC drug facts panel.

Science.gov (United States)

Bhansali, Archita H; Sangani, Darshan S; Mhatre, Shivani K; Sansgiry, Sujit S

2018-01-01

To compare three over-the-counter (OTC) Drug Facts panel versions for information processing optimization among college students. University of Houston students (N = 210) participated in a cross-sectional survey from January to May 2010. A current FDA label was compared to two experimental labels developed using the theory of CHREST to test information processing by re-positioning the warning information within the Drug Facts panel. Congruency was defined as placing like information together. Information processing was evaluated using the OTC medication Label Evaluation Process Model (LEPM): label comprehension, ease-of-use, attitude toward the product, product evaluation, and purchase intention. Experimental label with chunked congruent information (uses-directions-other information-warnings) was rated significantly higher than the current FDA label and had the best average scores among the LEPM information processing variables. If replications uphold these findings, the FDA label design might be revised to improve information processing.

The evolution of FDA policy on silicone breast implants: a case study of politics, bureaucracy, and business in the process of decision-making.

Science.gov (United States)

Palley, H A

1995-01-01

The central issue facing federal regulation of breast implants is that while such devices are not functionally necessary or needed for survival, the side effects may be harmful and have not been proven unharmful. The Medical Device Amendments of 1976 appear to require such evidence prior to the FDA permitting the unrestricted marketing of these devices. However, only recently have such requirements been imposed by the FDA. The author examines the FDA's decision-making process, particularly as applied to silicone breast implants, and the factors that appears to have affected such decisions. In pursuing this study, the activities of a number of interest-group actors, as well as congressional responses and the role of federal bureaucratic actors, were examined. In 1992, the FDA established a regulatory protocol that effectively withdrew most silicone breast implants from the market for the purpose of breast augmentation and allows for the monitoring of the impact of new implants on women's health. This increase concern for determining the safety of breast implants is due to a number of factors, which are examined in this article.

78 FR 14309 - Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish...

Science.gov (United States)

2013-03-05

... FDA's Product Tracing Web page at http://www.fda.gov/Food/FoodSafety/FSMA/ucm270851.htm . This... Submit a Report to Congress for the Improvement of Tracking and Tracing of Food; Request for Comments and... Institute of Food Technologists (IFT) to execute product tracing pilot projects as described in the FDA Food...

Solar panel parallel mounting configuration

Science.gov (United States)

Mutschler, Jr., Edward Charles (Inventor)

1998-01-01

A spacecraft includes a plurality of solar panels interconnected with a power coupler and an electrically operated device to provide power to the device when the solar cells are insolated. The solar panels are subject to bending distortion when entering or leaving eclipse. Spacecraft attitude disturbances are reduced by mounting each of the solar panels to an elongated boom made from a material with a low coefficient of thermal expansion, so that the bending of one panel is not communicated to the next. The boom may be insulated to reduce its bending during changes in insolation. A particularly advantageous embodiment mounts each panel to the boom with a single mounting, which may be a hinge. The single mounting prevents transfer of bending moments from the panel to the boom.

Control device for automatic orientation of a solar panel based on a microcontroller (PIC16f628a)

Science.gov (United States)

Rezoug, M. R.; Krama, A.

2016-07-01

This work proposes a control device for autonomous solar tracker based on one axis, It consists of two main parts; the control part which is based on "the PIC16f628a"; it has the role of controlling, measuring and plotting responses. The second part is a mechanical device, which has the role of making the solar panel follows the day-night change of the sun throughout the year. Both parties are established to improve energy generation of the photovoltaic panels. In this paper, we will explain the main operating principles of our system. Also, we will provide experimental results which demonstrate the good performance and the efficiency of this system. This innovation is different from what has been proposed in previous studies. The important points of this system are maximum output energy and minimum energy consumption of solar tracker, its cost is relatively low with simplicity in implementation. The average power increase produced by using the tracking system for a particular day, is over 30 % compared with the static panel.

Regulating (for the benefit of) future persons: a different perspective on the FDA's jurisdiction to regulate human reproductive cloning.

Science.gov (United States)

Javitt, Gail H; Hudson, Kathy

2003-01-01

The Food and Drug Administration (FDA) has taken the position that human reproductive cloning falls within its regulatory jurisdiction. This position has been subject to criticism on both procedural and substantive grounds. Some have contended that the FDA has failed to follow administrative law principles in asserting its jurisdiction, while others claim the FDA is ill suited to the task of addressing the ethical and social implications of human cloning. This Article argues, that, notwithstanding these criticisms, the FDA could plausibly assert jurisdiction over human cloning as a form of human gene therapy, an area in which the FDA is already regarded as having primary regulatory authority. Such an assertion would require that the FDA's jurisdiction extend to products affecting future persons, i.e., those not yet born. This Article demonstrates, for the first time, that such jurisdiction was implicit in the enactment of the 1962 Kefauver-Harris Amendments to the Federal Food, Drug, and Cosmetic Act and that the FDA has historically relied on such authority in promulgating regulations for drugs and devices.

FDA Peanut-Containing Product Recall

Data.gov (United States)

U.S. Department of Health & Human Services — The FDA Peanut-Containing Product Recall widget allows you to browse the Food and Drug Administration (FDA) database of peanut butter and peanut-containing products...

76 FR 64223 - Cardiovascular Devices; Reclassification of External Pacemaker Pulse Generator Devices

Science.gov (United States)

2011-10-17

... Drug Administration 21 CFR Part 870 Cardiovascular Devices; Reclassification of External Pacemaker... Special Controls Guidance Document: External Pacemaker Pulse Generator; Availability; Proposed Rule and... [Docket No. FDA-2011-N-0650] Cardiovascular Devices; Reclassification of External Pacemaker Pulse...

77 FR 14272 - Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus Serological...

Science.gov (United States)

2012-03-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2012-N-0165] Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus... AND MICROBIOLOGY DEVICES 0 1. The authority citation for 21 CFR part 866 continues to read as follows...

78 FR 46977 - Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Science.gov (United States)

2013-08-02

... intraoperative management of clear corneal incisions with a wound leak demonstrated by Seidel test, and for... a disability, please contact AnnMarie Williams at Annmarie.Williams@fda.hhs.gov or 301-796-5966, at...

Medical Device Regulation: A Comparison of the United States and the European Union.

Science.gov (United States)

Maak, Travis G; Wylie, James D

2016-08-01

Medical device regulation is a controversial topic in both the United States and the European Union. Many physicians and innovators in the United States cite a restrictive US FDA regulatory process as the reason for earlier and more rapid clinical advances in Europe. The FDA approval process mandates that a device be proved efficacious compared with a control or be substantially equivalent to a predicate device, whereas the European Union approval process mandates that the device perform its intended function. Stringent, peer-reviewed safety data have not been reported. However, after recent high-profile device failures, political pressure in both the United States and the European Union has favored more restrictive approval processes. Substantial reforms of the European Union process within the next 5 to 10 years will result in a more stringent approach to device regulation, similar to that of the FDA. Changes in the FDA regulatory process have been suggested but are not imminent.

78 FR 950 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

Science.gov (United States)

2013-01-07

..., FDA- 2012-M-0965, FDA-2012-M-0968, FDA-2012-M-1011, and FDA-2012-M-1013] Medical Devices; Availability.... Glucose Monitoring System (TGMS). P000008/S017, FDA-2012-M-1013.. Allergan, Inc..... LAP-BAND \\TM\\ February 16, 2011. Adjustable Gastric Banding System. P100049, FDA-2012-M-0893....... Torax Medical, Inc...

Adherence of pharmaceutical advertisements in medical journals to FDA guidelines and content for safe prescribing.

Science.gov (United States)

Korenstein, Deborah; Keyhani, Salomeh; Mendelson, Ali; Ross, Joseph S

2011-01-01

Physician-directed pharmaceutical advertising is regulated in the United States by the Food and Drug Administration (FDA); adherence to current FDA guidelines is unknown. Our objective was to determine adherence rates of physician-directed print advertisements in biomedical journals to FDA guidelines and describe content important for safe prescribing. Cross-sectional analysis of November 2008 pharmaceutical advertisements within top U.S.-based biomedical journals publishing original research. We excluded advertisements for devices, over the counter medications, and disease awareness. We utilized FDA guideline items identifying unique forms of advertisement bias to categorize advertisements as adherent to FDA guidelines, possibly non-adherent to at least 1 item, or non-adherent to at least 1 item. We also evaluated advertisement content important for safe prescribing, including benefit quantification, risk information and verifiable references. All advertisements were evaluated by 2 or more investigators, with differences resolved by discussion. Twelve journals met inclusion criteria. Nine contained pharmaceutical advertisements, including 192 advertisements for 82 unique products; median 2 per product (range 1-14). Six "teaser" advertisements presented only drug names, leaving 83 full unique advertisements. Fifteen advertisements (18.1%) adhered to all FDA guidelines, 41 (49.4%) were non-adherent with at least one form of FDA-described bias, and 27 (32.5%) were possibly non-adherent due to incomplete information. Content important for safe prescribing was often incomplete; 57.8% of advertisements did not quantify serious risks, 48.2% lacked verifiable references and 28.9% failed to present adequate efficacy quantification. Study limitations included its focus on advertisements from a single month, the subjectivity of FDA guidelines themselves, and the necessary subjectivity of determinations of adherence. Few physician-directed print pharmaceutical advertisements

Adherence of pharmaceutical advertisements in medical journals to FDA guidelines and content for safe prescribing.

Directory of Open Access Journals (Sweden)

Deborah Korenstein

Full Text Available Physician-directed pharmaceutical advertising is regulated in the United States by the Food and Drug Administration (FDA; adherence to current FDA guidelines is unknown. Our objective was to determine adherence rates of physician-directed print advertisements in biomedical journals to FDA guidelines and describe content important for safe prescribing.Cross-sectional analysis of November 2008 pharmaceutical advertisements within top U.S.-based biomedical journals publishing original research. We excluded advertisements for devices, over the counter medications, and disease awareness. We utilized FDA guideline items identifying unique forms of advertisement bias to categorize advertisements as adherent to FDA guidelines, possibly non-adherent to at least 1 item, or non-adherent to at least 1 item. We also evaluated advertisement content important for safe prescribing, including benefit quantification, risk information and verifiable references. All advertisements were evaluated by 2 or more investigators, with differences resolved by discussion. Twelve journals met inclusion criteria. Nine contained pharmaceutical advertisements, including 192 advertisements for 82 unique products; median 2 per product (range 1-14. Six "teaser" advertisements presented only drug names, leaving 83 full unique advertisements. Fifteen advertisements (18.1% adhered to all FDA guidelines, 41 (49.4% were non-adherent with at least one form of FDA-described bias, and 27 (32.5% were possibly non-adherent due to incomplete information. Content important for safe prescribing was often incomplete; 57.8% of advertisements did not quantify serious risks, 48.2% lacked verifiable references and 28.9% failed to present adequate efficacy quantification. Study limitations included its focus on advertisements from a single month, the subjectivity of FDA guidelines themselves, and the necessary subjectivity of determinations of adherence.Few physician-directed print pharmaceutical

High energy devices versus low energy devices in orthopedics treatment modalities

Science.gov (United States)

Schultheiss, Reiner

2003-10-01

The orthopedic consensus group defined in 1997 the 42 most likely relevant parameters of orthopedic shock wave devices. The idea of this approach was to correlate the different clinical outcomes with the physical properties of the different devices with respect to their acoustical waves. Several changes in the hypothesis of the dose effect relationship have been noticed since the first orthopedic treatments. The relation started with the maximum pressure p+, followed by the total energy, the energy density; and finally the single treatment approach using high, and then the multiple treatment method using low energy. Motivated by the reimbursement situation in Germany some manufacturers began to redefine high and low energy devices independent of the treatment modality. The OssaTron as a high energy, single treatment electro hydraulic device gained FDA approval as the first orthopedic ESWT device for plantar fasciitis and, more recently, for lateral epicondylitis. Two low energy devices have now also gained FDA approval based upon a single treatment. Comparing the acoustic data, differences between the OssaTron and the other devices are obvious and will be elaborated upon. Cluster analysis of the outcomes and the acoustical data are presented and new concepts will be suggested.

78 FR 79304 - Cardiovascular Devices; Reclassification of External Counter-Pulsating Devices for Treatment of...

Science.gov (United States)

2013-12-30

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 870 [Docket No. FDA-2013-N-0487] Cardiovascular Devices; Reclassification of External Counter- Pulsating Devices for...--CARDIOVASCULAR DEVICES 0 1. The authority citation for 21 CFR part 870 continues to read as follows: Authority...

75 FR 68200 - Medical Devices; Radiology Devices; Reclassification of Full-Field Digital Mammography System

Science.gov (United States)

2010-11-05

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 892 [Docket No. FDA-2008-N-0273] Medical Devices; Radiology Devices; Reclassification of Full- Field Digital... and Drugs, 21 CFR part 892 is amended as follows: PART 892--RADIOLOGY DEVICES 0 1. The authority...

75 FR 17093 - Neurological and Physical Medicine Devices; Designation of Special Controls for Certain Class II...

Science.gov (United States)

2010-04-05

... preamendments devices) have been classified by FDA under the procedures set forth in section 513(c) and (d) of... premarket approval, unless FDA initiates the following procedures: (1) FDA reclassifies the device into...)), the transcutaneous electrical stimulator for aesthetic purposes (Sec. 882.5890(e)), and the...

Medical Devices; General Hospital and Personal Use Devices; Classification of the Ultraviolet Radiation Chamber Disinfection Device. Final order.

Science.gov (United States)

2015-11-20

The Food and Drug Administration (FDA or the Agency) is classifying the ultraviolet (UV) radiation chamber disinfection device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the UV radiation chamber disinfection device classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey

Directory of Open Access Journals (Sweden)

Ross JS

2015-05-01

Full Text Available Joseph S Ross, Katrina L Blount, Jessica D Ritchie, Beth Hodshon, Harlan M Krumholz Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA Background: In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA's pre-market approval (PMA pathway. Methods and results: We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%, nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Conclusion: Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives. Keywords: FDA, PMA pathway, post-market surveillance

75 FR 54493 - Cardiovascular Devices; Reclassification of Certain Percutaneous Transluminal Coronary...

Science.gov (United States)

2010-09-08

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 870 [Docket No. FDA-2000-P-0924] (formerly Docket No. FDA-2000-P-1533) Cardiovascular Devices; Reclassification of... follows: PART 870--CARDIOVASCULAR DEVICES 0 1. The authority citation for 21 CFR part 870 continues to...

Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey.

Science.gov (United States)

Ross, Joseph S; Blount, Katrina L; Ritchie, Jessica D; Hodshon, Beth; Krumholz, Harlan M

2015-01-01

In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA) to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA's pre-market approval (PMA) pathway. We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%), nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives.

77 FR 19534 - Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus Serological...

Science.gov (United States)

2012-04-02

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2012-N-0165] Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus Serological Reagents; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; correction...

76 FR 21237 - Medical Devices; Obstetrical and Gynecological Devices; Classification of the Hemorrhoid...

Science.gov (United States)

2011-04-15

... type of device must submit to FDA a premarket notification, prior to marketing the device, which... directs agencies to assess all costs and benefits of available regulatory alternatives and, when... economic, environmental, public health and safety, and other advantages; distributive impacts; and equity...

Reflecting variable opening insulating panel

International Nuclear Information System (INIS)

Nungesser, W.T.

1976-01-01

A description is given of a reflecting variable opening insulating panel assembly, comprising a static panel assembly of reflecting insulation sheets forming a cavity along one side of the panel and a movable panel opening out by sliding from the cavity of the static panel, and a locking device for holding the movable panel in a position extending from the cavity of the static panel. This can apply to a nuclear reactor of which the base might require maintenance and periodical checking and for which it is desirable to have available certain processes for the partial dismantling of the insulation [fr

77 FR 7589 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Science.gov (United States)

2012-02-13

... ongoing randomized clinical trial, ``Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis'' (SAMMPRIS), published in the New England Journal of Medicine (2011;365...-0923. FDA intends to make background material available to the public no later than 2 business days...

76 FR 22322 - Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass...

Science.gov (United States)

2011-04-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2010-N-0026] Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass Assessment Score Test System; Correction AGENCY: Food and Drug Administration, HHS. ACTION...

77 FR 19293 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Meeting

Science.gov (United States)

2012-03-30

... population (Ref. 3). This peer-reviewed journal article presented the following findings regarding primary Mo... resurfacing). FDA intends to make background material available to the public no later than 2 business days... Implants: A Technology Overview'' (July 15, 2011), accessed online at http://www.aaos.org/research...

75 FR 70112 - Medical Devices; General and Plastic Surgery Devices; Classification of Non-Powered Suction...

Science.gov (United States)

2010-11-17

.... FDA-2010-N-0513] Medical Devices; General and Plastic Surgery Devices; Classification of Non-Powered... risks. Adverse tissue reaction Material degradation Improper function of suction apparatus (e.g., reflux.... Material degradation Section 8. Stability and Shelf Life. [[Page 70113

77 FR 69488 - Medical Devices; Custom Devices; Request for Comments

Science.gov (United States)

2012-11-19

... strategy and policy for the custom device exemption criteria in the FD&C Act amended by FDASIA. FDA is... States in finished form through labeling or advertising by the manufacturer, importer, or distributor for...

78 FR 17415 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

Science.gov (United States)

2013-03-21

... its decision. The regulations provide that FDA publish a quarterly list of available safety and..., FDA-2012-M-1183, and FDA-2012-M-1184] Medical Devices; Availability of Safety and Effectiveness.... SUMMARY: The Food and Drug Administration (FDA) is publishing a list of premarket approval applications...

76 FR 43119 - Medical Devices; General and Plastic Surgery Devices; Classification of the Focused Ultrasound...

Science.gov (United States)

2011-07-20

... type of device must submit to FDA a premarket notification, prior to marketing the device, which... Orders 12866 and 13563 direct Agencies to assess all costs and benefits of available regulatory... (including potential economic, environmental, public health and safety, and other advantages; distributive...

75 FR 68972 - Medical Devices; General and Plastic Surgery Devices; Classification of Tissue Adhesive With...

Science.gov (United States)

2010-11-10

.... FDA-2010-N-0512] Medical Devices; General and Plastic Surgery Devices; Classification of Tissue... running to unintended areas, etc. B. Wound dehiscence C. Adverse tissue reaction and chemical burns D..., Clinical Studies, Labeling. Adverse tissue reaction and chemical Biocompatibility Animal burns. Testing...

Point-Counterpoint: The FDA Has a Role in Regulation of Laboratory-Developed Tests.

Science.gov (United States)

Caliendo, Angela M; Hanson, Kimberly E

2016-04-01

Since the Food and Drug Administration (FDA) released its draft guidance on the regulation of laboratory-developed tests (LDTs) in October 2014, there has been a flurry of responses from commercial and hospital-based laboratory directors, clinicians, professional organizations, and diagnostic companies. The FDA defines an LDT as an "in vitrodiagnostic device that is intended for clinical use and is designed, manufactured, and used within a single laboratory." The draft guidance outlines a risk-based approach, with oversight of high-risk and moderate-risk tests being phased in over 9 years. High-risk tests would be regulated first and require premarket approval. Subsequently, moderate-risk tests would require a 510(k) premarket submission to the FDA and low-risk tests would need only to be registered. Oversight discretion would be exercised for LDTs focused on rare diseases (defined as fewer than 4,000 tests, not cases, per year nationally) and unmet clinical needs (defined as those tests for which there is no alternative FDA-cleared or -approved test). There was an open comment period followed by a public hearing in early January of 2015, and we are currently awaiting the final decision regarding the regulation of LDTs. Given that LDTs have been developed by many laboratories and are essential for the diagnosis and monitoring of an array of infectious diseases, changes in their regulation will have far-reaching implications for clinical microbiology laboratories. In this Point-Counterpoint, Angela Caliendo discusses the potential benefits of the FDA guidance for LDTs whereas Kim Hanson discusses the concerns associated with implementing the guidance and why these regulations may not improve clinical care. Copyright © 2016, American Society for Microbiology. All Rights Reserved.

76 FR 16292 - Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass...

Science.gov (United States)

2011-03-23

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2011-N-0026] Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian... of Food and Drugs, 21 CFR part 866 is amended as follows: PART 866--IMMUNOLOGY AND MICROBIOLOGY...

77 FR 50701 - Radiological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Science.gov (United States)

2012-08-22

..., sponsored by Hologic, Inc. The Selenia Dimensions 3D System is currently approved for breast cancer screening and diagnosis. The screening exam can consist of field digital mammography (FFDM) alone or the... combination of DBT with synthetic 2D images to be used as another exam option for breast cancer screening. FDA...

76 FR 41507 - Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Science.gov (United States)

2011-07-14

... consider surgical mesh used to treat stress urinary incontinence. FDA intends to make background material... contact person and submit a brief statement of the general nature of the evidence or arguments they wish...

Medical devices; immunology and microbiology devices; classification of John Cunningham Virus serological reagents. Final order.

Science.gov (United States)

2014-01-23

The Food and Drug Administration (FDA) is classifying John Cunningham Virus (JCV) serological reagents into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

21 CFR 60.34 - FDA action on petitions.

Science.gov (United States)

2010-04-01

... RESTORATION Due Diligence Petitions § 60.34 FDA action on petitions. (a) Within 90 days after FDA receives a... this section or investigate and determine under § 60.36 whether the applicant acted with due diligence during the regulatory review period. FDA will publish its due diligence determination in the Federal...

76 FR 63928 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Science.gov (United States)

2011-10-14

..., releasing the Sensor. Electronics Unit (Interrogator) and database--The Electronics Unit contains hardware... transmitted from the electronics unit, and presents the data for review by medical professionals. FDA intends... person on or before November 30, 2011. Oral presentations from the public will be scheduled between...

77 FR 48160 - Division of Cardiovascular Devices 30-Day Notices and Annual Reports; Public Workshop; Request...

Science.gov (United States)

2012-08-13

... performed. For parking and security information, please refer to: http://www.fda.gov/AboutFDA/WorkingatFDA... attendee, including name, title, affiliation, address, email, and telephone number. Those without Internet... the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm...

Photobiomodulation therapy for androgenetic alopecia: A clinician's guide to home-use devices cleared by the Federal Drug Administration.

Science.gov (United States)

Dodd, Erin M; Winter, Margo A; Hordinsky, Maria K; Sadick, Neil S; Farah, Ronda S

2018-06-01

The market for home-use photobiomodulation devices to treat androgenetic alopecia has rapidly expanded, and the Food and Drug Administration (FDA) has recently cleared many devices for this purpose. Patients increasingly seek the advice of dermatologists regarding the safety and efficacy of these hair loss treatments. The purpose of this guide was threefold: (1) to identify all home-use photobiomodulation therapy devices with FDA-clearance for treatment of androgenetic alopecia; (2) to review device design, features and existing clinical evidence; and (3) to discuss practical considerations of photobiomodulation therapy, including patient suitability, treatment goals, safety, and device selection. A search of the FDA 510(k) Premarket Notification database was conducted using product code "OAP" to identify all home-use devices that are FDA-cleared to treat androgenetic alopecia. Thirteen commercially available devices were identified and compared. Devices varied in shape, wavelength, light sources, technical features, price, and level of clinical evidence. To date, there are no head-to-head studies comparing the efficacy of these devices. Photobiomodulation therapy devices have an excellent safety profile and mounting evidence supporting their efficacy. However, long-term, high quality studies comparing these devices in diverse populations are lacking. As these devices become increasingly popular, dermatologists should be familiar with this treatment modality to add to their therapeutic armamentarium. AGA, androgenetic alopecia; FDA, Food and Drug Administration; IEC, International Electrotechnical Commission; LED, light-emitting diode; PBMT, photobiomodulation therapy.

Real-World Evidence, Public Participation, and the FDA.

Science.gov (United States)

Schwartz, Jason L

2017-11-01

For observers of pharmaceutical regulation and the Food and Drug Administration, these are uncertain times. Events in late 2016 raised concerns that the FDA's evidentiary standards were being weakened, compromising the agency's ability to adequately perform its regulatory and public health responsibilities. Two developments most directly contributed to these fears-the approval of eteplirsen, a treatment for Duchenne muscular dystrophy, against the recommendations of both FDA staff and an advisory committee and the December 2016 signing of the 21st Century Cures Act, which encouraged greater use by the FDA of "real-world" evidence not obtained through randomized controlled trials. The arrival of the Trump administration-with its deregulatory, industry-friendly approach-has only amplified concerns over the future of the FDA. It is too early to know whether the recent developments are truly harbingers of an FDA less likely to prevent unsafe or ineffective products from reaching the market. But elements in the two events-the role of patient narratives in deliberations regarding eteplirsen and the enthusiasm for real-world evidence in the 21st Century Cures Act-raise critical issues for the future of evidence in the FDA's work. The rigorous, inclusive approach under way to consider issues related to real-world evidence provides a model for a similarly needed inquiry regarding public participation in FDA decision-making. © 2017 The Hastings Center.

Human health and ecological toxicity potentials due to heavy metal content in waste electronic devices with flat panel displays

International Nuclear Information System (INIS)

Lim, Seong-Rin; Schoenung, Julie M.

2010-01-01

Display devices such as cathode-ray tube (CRT) televisions and computer monitors are known to contain toxic substances and have consequently been banned from disposal in landfills in the State of California and elsewhere. New types of flat panel display (FPD) devices, millions of which are now purchased each year, also contain toxic substances, but have not previously been systematically studied and compared to assess the potential impact that could result from their ultimate disposal. In the current work, the focus is on the evaluation of end-of-life toxicity potential from the heavy metal content in select FPD devices with the intent to inform material selection and design-for-environment (DfE) decisions. Specifically, the metals antimony, arsenic, barium, beryllium, cadmium, chromium, cobalt, copper, lead, mercury, molybdenum, nickel, selenium, silver, vanadium, and zinc in plasma TVs, LCD (liquid crystal display) TVs, LCD computer monitors and laptop computers are considered. The human health and ecotoxicity potentials are evaluated through a life cycle assessment perspective by combining data on the respective heavy metal contents, the characterization factors in the U.S. EPA Tool for the Reduction and Assessment of Chemical and other environmental Impacts (TRACI), and a pathway and impact model. Principal contributors to the toxicity potentials are lead, arsenic, copper, and mercury. Although the heavy metal content in newer flat panel display devices creates less human health toxicity potential than that in CRTs, for ecological toxicity, the new devices are worse, especially because of the mercury in LCD TVs and the copper in plasma TVs.

Magnetic evaluation of a solar panel using HTS-SQUID

Energy Technology Data Exchange (ETDEWEB)

Kiwa, Toshihiko, E-mail: kiwa@okayama-u.ac.jp; Fukudome, Yohei; Miyazaki, Shingo; Saari, Mohd Mawardi; Sakai, Kenji; Tsukada, Keiji

2013-11-15

Highlights: •The magnetic evaluation system of a solar panel using HTS-SQUID has been developed. •The electric circuits made by the discrete devices on the circuit board were visualized. •The electric properties of the commercial solar panels were demonstrated. -- Abstract: The magnetic evaluation system of a solar panel using HTS-SQUID has been proposed and developed. A normal pick-up coil was applied to detect the tangential magnetic field to the panel surface. Since the detected field could be related to the currents of the solar panels, the electric properties of the solar panels could be evaluated. In this work, the evaluation of the electric properties of the commercial solar panels as well as the electric circuits made by the discrete devices on the circuit board was visualized.

Magnetic evaluation of a solar panel using HTS-SQUID

International Nuclear Information System (INIS)

Kiwa, Toshihiko; Fukudome, Yohei; Miyazaki, Shingo; Saari, Mohd Mawardi; Sakai, Kenji; Tsukada, Keiji

2013-01-01

Highlights: •The magnetic evaluation system of a solar panel using HTS-SQUID has been developed. •The electric circuits made by the discrete devices on the circuit board were visualized. •The electric properties of the commercial solar panels were demonstrated. -- Abstract: The magnetic evaluation system of a solar panel using HTS-SQUID has been proposed and developed. A normal pick-up coil was applied to detect the tangential magnetic field to the panel surface. Since the detected field could be related to the currents of the solar panels, the electric properties of the solar panels could be evaluated. In this work, the evaluation of the electric properties of the commercial solar panels as well as the electric circuits made by the discrete devices on the circuit board was visualized

The first FDA marketing authorizations of next-generation sequencing technology and tests: challenges, solutions and impact for future assays.

Science.gov (United States)

Bijwaard, Karen; Dickey, Jennifer S; Kelm, Kellie; Težak, Živana

2015-01-01

The rapid emergence and clinical translation of novel high-throughput sequencing technologies created a need to clarify the regulatory pathway for the evaluation and authorization of these unique technologies. Recently, the US FDA authorized for marketing four next generation sequencing (NGS)-based diagnostic devices which consisted of two heritable disease-specific assays, library preparation reagents and a NGS platform that are intended for human germline targeted sequencing from whole blood. These first authorizations can serve as a case study in how different types of NGS-based technology are reviewed by the FDA. In this manuscript we describe challenges associated with the evaluation of these novel technologies and provide an overview of what was reviewed. Besides making validated NGS-based devices available for in vitro diagnostic use, these first authorizations create a regulatory path for similar future instruments and assays.

EVA geen FDA

NARCIS (Netherlands)

Folbert, J.P.; Dagevos, J.C.

2001-01-01

De oprichting van een Europese Voedselautoriteit die in 2002 operationeel moet zijn. Velen zien hierin een evenbeeld van de Amerikaanse FDA (Food and Drug Administration). Deze instantie werkt echter niet zo ideaal als vaak wordt voorgesteld. Het belangrijkste verschil tussen beide instanties is de

[Consideration of Mobile Medical Device Regulation].

Science.gov (United States)

Peng, Liang; Yang, Pengfei; He, Weigang

2015-07-01

The regulation of mobile medical devices is one of the hot topics in the industry now. The definition, regulation scope and requirements, potential risks of mobile medical devices were analyzed and discussed based on mobile computing techniques and the FDA guidance of mobile medical applications. The regulation work of mobile medical devices in China needs to adopt the risk-based method.

FDA Drug Label Data

Data.gov (United States)

U.S. Department of Health & Human Services — This file contains the data elements used for searching the FDA Online Data Repository including proprietary name, active ingredients, marketing application number...

FDA and the Chemical Brain Drainers

DEFF Research Database (Denmark)

Grandjean, Philippe

2017-01-01

Comment to: "Anesthesia and Developing Brains — Implications of the FDA Warning." Dean B. Andropoulos, M.D., M.H.C.M., and Michael F. Greene, M.D. N Engl J Med 2017; 376:905-907......Comment to: "Anesthesia and Developing Brains — Implications of the FDA Warning." Dean B. Andropoulos, M.D., M.H.C.M., and Michael F. Greene, M.D. N Engl J Med 2017; 376:905-907...

Medical devices; neurological devices; classification of the transcranial magnetic stimulator for headache. Final order.

Science.gov (United States)

2014-07-08

The Food and Drug Administration (FDA) is classifying the transcranial magnetic stimulator for headache into class II (special controls). The special controls that will apply to the device are identified in this order, and will be part of the codified language for the transcranial magnetic stimulator for headache classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

FDA Recognized Consensus Standards

Data.gov (United States)

U.S. Department of Health & Human Services — This database consists of those national and international standards recognized by FDA which manufacturers can declare conformity to and is part of the information...

75 FR 18219 - Drug and Medical Device Forum on Food and Drug Administration Drug and Device Requirements and...

Science.gov (United States)

2010-04-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0142] Drug and Medical Device Forum on Food and Drug Administration Drug and Device Requirements and Supplier Controls; Public Educational Forum AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public...

21 CFR 60.10 - FDA assistance on eligibility.

Science.gov (United States)

2010-04-01

... from the U.S. Patent and Trademark Office, FDA will assist the U.S. Patent and Trademark Office in... in FDA's Division of Dockets Management (HFA-305), 5630 Fishers Lane, rm. 1061, Rockville, MD 20852...

Panel discussion: Chemistry aspects of pet radiotracers

International Nuclear Information System (INIS)

Kilbourn, M.R.

1991-01-01

A panel discussion on the radiotracer development process opened with a question regarding the role of toxicological studies in the process of obtaining a physician-sponsored Investigational New Drug (IND) for a new radiopharmaceutical. Panel members were uniformly supportive of new radiotracer development, expressing their opinions that the regulatory hurdles were there but could be overcome. Several institutions are actively working with regulatory agencies to determine just what toxicology data are relevant to new radiopharmaceutical development in the PET field. The FDA is beginning to understand that the pharmacology of PET tracer doses may be completely different from what is usually important in drug trials. The second part of the panel discussion centered on the role, if any, of the pharmaceutical companies in new radiotracer development. It was pointed out that what the radiochemist is looking for in a radiopharmaceutical is different from what these companies are searching for in a therapeutic drug. Panel and audience members responded to the question: What would a pharmaceutical company gain from collaboration with radiopharmaceutical research laboratories? Several examples were given such as providing crucial data from humans rather than animals; determining individualized drug doses to maximize the therapeutic index of a new drug regimen; and replacing the large amounts of time and money currently invested by drug companies in the radiolabeling and evaluation of metabolites of new drugs

Medical devices; immunology and microbiology devices; classification of nucleic acid-based devices for the detection of Mycobacterium tuberculosis complex and the genetic mutations associated with antibiotic resistance. Final order.

Science.gov (United States)

2014-10-22

The Food and Drug Administration (FDA) is classifying nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex (MTB-complex) and the genetic mutations associated with MTB-complex antibiotic resistance in respiratory specimens devices into class II (special controls). The Agency is classifying the device into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of the device.

76 FR 80949 - Request for Nominations for Voting Members on Public Advisory Panels or Committees

Science.gov (United States)

2011-12-27

.... Orthopedic and Rehabilitation Devices Panel. Jamie Waterhouse, Center for Devices Circulatory System Devices... Advisory Committee--Neurosurgeons (cerebrovascular and pediatric), neurologists (stroke, pediatric, pain... ophthalmic clinical trials. Orthopaedic and 2 September 1, 2012. Rehabilitation Devices Panel of the Medical...

Micro-inverter solar panel mounting

Science.gov (United States)

Morris, John; Gilchrist, Phillip Charles

2016-02-02

Processes, systems, devices, and articles of manufacture are provided. Each may include adapting micro-inverters initially configured for frame-mounting to mounting on a frameless solar panel. This securement may include using an adaptive clamp or several adaptive clamps secured to a micro-inverter or its components, and using compressive forces applied directly to the solar panel to secure the adaptive clamp and the components to the solar panel. The clamps can also include compressive spacers and safeties for managing the compressive forces exerted on the solar panels. Friction zones may also be used for managing slipping between the clamp and the solar panel during or after installation. Adjustments to the clamps may be carried out through various means and by changing the physical size of the clamps themselves.

Changes In Growth Culture FDA Activity Under Changing Growth Conditions

DEFF Research Database (Denmark)

Jørgensen, Per Elberg; Eriksen, Thomas Juul; Jensen, Bjørn K.

1992-01-01

The FDA hydrolysis capacities and bacterial biomass concentrations (estimated by determination of ATP content) of growth cultures prepared from activated sludge and wastewater, were measured to find out whether the FDA activity would reflect bacterial biomass under different physiological states...... of the bacteria. The FDA activity/ATP ratio was calculated for different concentrations of autoclaved sludge. A faster decay rate of ATP relative to FDA hydrolysis activity was observed, thus causing changes in the ratio. Furthermore, comparison between values obtained from pure cultures and different soils...... revealed differences up to two orders of magnitude of the ratio. Based on these results it was concluded that the FDA activity should not be applied for measurements of viable biomass in environments in which different physiological conditions occur....

77 FR 41417 - Regulatory Science Considerations for Medical Countermeasure Radiation Biodosimetry Devices

Science.gov (United States)

2012-07-13

... scientific and technological challenges for performance validation of radiation biodosimetry devices. Date... participants (non-FDA employees) is through Bldg. 1 where routine security check procedures will be performed... this document. FDA will do its best to accommodate requests to make public comment. Individuals and...

Subarray-based FDA radar to counteract deceptive ECM signals

Science.gov (United States)

Abdalla, Ahmed; Wang, Wen-Qin; Yuan, Zhao; Mohamed, Suhad; Bin, Tang

2016-12-01

In recent years, the frequency diverse array (FDA) radar concept has attracted extensive attention, as it may benefit from a small frequency increment, compared to the carrier frequency across the array elements and thereby achieve an array factor that is a function of the angle, the time, and the range which is superior to the conventional phase array radar (PAR). However, limited effort on the subject of FDA in electronic countermeasure scenarios, especially in the presence of mainbeam deceptive jamming, has been published. Basic FDA is not desirable for anti-jamming applications, due to the range-angle coupling response of targets. In this paper, a novel method based on subarrayed FDA signal processing is proposed to counteract deceptive ECM signals. We divide the FDA array into multiple subarrays, each of which employs a distinct frequency increment. As a result, in the subarray-based FDA, the desired target can be distinguished at subarray level in joint range-angle-Doppler domain by utilizing the fact that the jammer generates false targets with the same ranges to each subarray without reparations. The performance assessment shows that the proposed solution is effective for deceptive ECM targets suppression. The effectiveness is verified by simulation results.

76 FR 20840 - Medical Devices; General and Plastic Surgery Devices; Classification of the Low Level Laser...

Science.gov (United States)

2011-04-14

... looking directly at the laser beam and the wearing of appropriate laser safety eyewear by both the user...). The special control for this device is the FDA guidance document entitled ``Guidance for Industry and...

Integration of new technology into clinical practice after FDA approval.

Science.gov (United States)

Govil, Ashul; Hao, Steven C

2016-10-01

Development of new medical technology is a crucial part of the advancement of medicine and our ability to better treat patients and their diseases. This process of development is long and arduous and requires a significant investment of human, financial and material capital. However, technology development can be rewarded richly by its impact on patient outcomes and successful sale of the product. One of the major regulatory hurdles to technology development is the Food and Drug Administration (FDA) approval process, which is necessary before a technology can be marketed and sold in the USA. Many businesses, medical providers and consumers believe that the FDA approval process is the only hurdle prior to use of the technology in day-to-day care. In order for the technology to be adopted into clinical use, reimbursement for both the device as well as the associated work performed by physicians and medical staff must be in place. Work and coverage decisions require Current Procedural Terminology (CPT) code development and Relative Value Scale Update Committee (RUC) valuation determination. Understanding these processes is crucial to the timely availability of new technology to patients and providers. Continued and better partnerships between physicians, industry, regulatory bodies and payers will facilitate bringing technology to market sooner and ensure appropriate utilization.

75 FR 49502 - Medical Device User Fee Act; Public Meeting; Request for Comments

Science.gov (United States)

2010-08-13

... of all stakeholder interest groups. Registrants will receive confirmation once they have been... FDA and a series of panels representing different stakeholder interest groups (such as patient... public meeting, interested persons may submit either electronic or written comments by October 14, 2010...

Localized environment characterization device

KAUST Repository

Alzain, Hashim

2016-07-21

Various apparatuses and methods are provided for measuring the likely environmental impact of a particular geographic location on power generation properties of potential solar installations at the particular location. In an example embodiment of one such apparatus, a measurement device is provided. The measurement device includes a base portion comprising a base frame element disposed on a plurality of supporting legs, and a top panel comprising a series of connected members and one or more measurement modules whose planar dimensions are defined by the series of connected members. The top panel is connected to the base portion by a joint such that the top panel can rotate about the joint, and a panel support element is configured to fasten the top panel immovably at a desired degree of rotation in relation to the base portion.

Evolution of atherectomy devices.

Science.gov (United States)

Al Khoury, G; Chaer, R

2011-08-01

Percutaneous atherectomy provides an alternative approach to the endovascular treatment of peripheral atherosclerotic occlusive disease beyond angioplasty and stenting, and has the theoretical advantage of lesion debulking and minimizing barotrauma to the vessel wall. Atherectomy has evolved greatly during the last decade, with currently four FDA approved devices for the treatment of peripheral arterial disease. Several reports have focused on the initial technical success rates, and demonstrated the safety and short as well as mid-term efficacy of atherectomy devices. This article will review the evolution of current atherectomy devices and the associated literature.

76 FR 1180 - FDA Transparency Initiative: Improving Transparency to Regulated Industry

Science.gov (United States)

2011-01-07

...] FDA Transparency Initiative: Improving Transparency to Regulated Industry AGENCY: Food and Drug... the Transparency Initiative, the Food and Drug Administration (FDA) is announcing the availability of a report entitled ``FDA Transparency Initiative: Improving Transparency to Regulated Industry.'' The...

Medical devices; exemption from premarket notification; Class II devices; optical impression systems for computer assisted design and manufacturing. Final rule.

Science.gov (United States)

2003-04-22

The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for data acquisition units for ceramic dental restoration systems. This rule exempts from premarket notification data acquisition units for ceramic dental restoration systems and establishes a guidance document as a special control for this device. FDA is publishing this order in accordance with the Food and Drug Administration Modernization Act of 1997 (FDAMA).

76 FR 45825 - Center for Devices and Radiological Health 510(k) Clearance Process; Institute of Medicine Report...

Science.gov (United States)

2011-08-01

... Drug Administration (FDA) is requesting comments on the Institute of Medicine (IOM) report entitled... assessment of the 510(k) process was an independent study by the IOM. At the request of FDA, IOM has..., 2011, IOM released the report ``Medical Devices and the Public's Health, The FDA 510(k) Clearance...

21 CFR 312.86 - Focused FDA regulatory research.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Focused FDA regulatory research. 312.86 Section 312.86 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency...

Medical devices; neurological devices; classification of the transcutaneous electrical nerve stimulator to treat headache. Final order.

Science.gov (United States)

2014-07-03

The Food and Drug Administration (FDA) is classifying the transcutaneous electrical nerve stimulator to treat headache into class II (special controls). The special controls that will apply to the device are identified in this order, and will be part of the codified language for the transcutaneous electrical nerve stimulator to treat headache classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

75 FR 15439 - Food and Drug Administration/Xavier University Global Medical Device Conference

Science.gov (United States)

2010-03-29

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Food and Drug Administration/Xavier University Global Medical Device Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY: The Food and Drug Administration (FDA...

78 FR 15957 - Food and Drug Administration/Xavier University Global Medical Device Conference

Science.gov (United States)

2013-03-13

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Food and Drug Administration/Xavier University Global Medical Device Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY: The Food and Drug Administration (FDA...

77 FR 10537 - Food and Drug Administration/Xavier University Global Medical Device Conference

Science.gov (United States)

2012-02-22

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Food and Drug Administration/Xavier University Global Medical Device Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY: The Food and Drug Administration (FDA...

Medical Devices; Obstetrical and Gynecological Devices; Classification of the Fetal Head Elevator. Final order.

Science.gov (United States)

2017-12-19

The Food and Drug Administration (FDA or we) is classifying the fetal head elevator into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the fetal head elevator's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Microbial Pathogen Nucleic Acids in Cerebrospinal Fluid. Final order.

Science.gov (United States)

2017-10-20

The Food and Drug Administration (FDA or we) is classifying the device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid into class II (special controls). The special controls that will apply to the device type are identified in this order and will be part of the codified language for the device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid’s classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Class 1 devices case studies in medical devices design

CERN Document Server

Ogrodnik, Peter J

2014-01-01

The Case Studies in Medical Devices Design series consists of practical, applied case studies relating to medical device design in industry. These titles complement Ogrodnik's Medical Device Design and will assist engineers with applying the theory in practice. The case studies presented directly relate to Class I, Class IIa, Class IIb and Class III medical devices. Designers and companies who wish to extend their knowledge in a specific discipline related to their respective class of operation will find any or all of these titles a great addition to their library. Class 1 Devices is a companion text to Medical Devices Design: Innovation from Concept to Market. The intention of this book, and its sister books in the series, is to support the concepts presented in Medical Devices Design through case studies. In the context of this book the case studies consider Class I (EU) and 510(k) exempt (FDA) . This book covers classifications, the conceptual and embodiment phase, plus design from idea to PDS. These title...

Circuits in the Sun: Solar Panel Physics

Science.gov (United States)

Gfroerer, Tim

2013-01-01

Typical commercial solar panels consist of approximately 60 individual photovoltaic cells connected in series. Since the usual Kirchhoff rules apply, the current is uniform throughout the circuit, while the electric potential of the individual devices is cumulative. Hence, a solar panel is a good analog of a simple resistive series circuit, except…

78 FR 1162 - Cardiovascular Devices; Reclassification of External Cardiac Compressor

Science.gov (United States)

2013-01-08

.... FDA-2012-N-1173] Cardiovascular Devices; Reclassification of External Cardiac Compressor AGENCY: Food... external cardiac compressors as class III requiring premarket approval. The Cardiovascular Device... on CPR and emergency cardiovascular care (Ref. 1) conclude that ``real-time CPR prompting and...

Thermal Analysis of Solar Panels

Science.gov (United States)

Barth, Nicolas; de Correia, João Pedro Magalhães; Ahzi, Saïd; Khaleel, Mohammad Ahmed

In this work, we propose to analyze the thermal behavior of PV panels using finite element simulations (FEM). We applied this analysis to compute the temperature distribution in a PV panel BP 350 subjected to different atmospheric conditions. This analysis takes into account existing formulations in the literature and, based on NOCT conditions, meteorological data was used to validate our approach for different wind speed and solar irradiance. The electrical performance of the PV panel was also studied. The proposed 2D FEM analysis is applied to different region's climates and was also used to consider the role of thermal inertia on the optimization of the PV device efficiency.

Gottlieb, the FDA and dumbing down medicine

OpenAIRE

Robbins RA

2017-01-01

No abstract available. Article truncated at 150 words. In the last few weeks several events have occurred that might impact drug approval in the US. President Donald Trump's pick for FDA commissioner, Dr. Scott Gottlieb. Gottlieb, like many of Trump’s picks for administration healthcare positions, is a physician. He also has experience as deputy FDA commissioner from 2005-7. However, his confirmation hearing before the Senate Committee on Health, Education, Labor and Pensions alarmed some wh...

77 FR 60704 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

Science.gov (United States)

2012-10-04

... regulations provide that FDA publish a quarterly list of available safety and effectiveness summaries of PMA...-0638] Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval... Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This...

76 FR 81363 - Temperature-Indicating Devices; Thermally Processed Low-Acid Foods Packaged in Hermetically...

Science.gov (United States)

2011-12-28

... amended FDA's regulations for thermally processed low-acid foods packaged in hermetically sealed... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 113 [Docket No. FDA-2007-N-0265] (formerly 2007N-0026) Temperature-Indicating Devices; Thermally Processed Low-Acid...

Medical Devices; Neurological Devices; Classification of the External Vagal Nerve Stimulator for Headache. Final order.

Science.gov (United States)

2017-12-27

The Food and Drug Administration (FDA or we) is classifying the external vagal nerve stimulator for headache into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the external vagal nerve stimulator for headache's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Advancing regulatory science to bring novel medical devices for use in emergency care to market: the role of the Food and Drug Administration.

Science.gov (United States)

Scully, Christopher G; Forrest, Shawn; Galeotti, Loriano; Schwartz, Suzanne B; Strauss, David G

2015-04-01

The Food and Drug Administration (FDA) performs regulatory science to provide science-based medical product regulatory decisions. This article describes the types of scientific research the FDA's Center for Devices and Radiological Health performs and highlights specific projects related to medical devices for emergency medicine. In addition, this article discusses how results from regulatory science are used by the FDA to support the regulatory process as well as how the results are communicated to the public. Regulatory science supports the FDA's mission to assure safe, effective, and high-quality medical products are available to patients. Published by Elsevier Inc.

42 CFR 405.753 - Appeal of a categorization of a device.

Science.gov (United States)

2010-10-01

... 42 Public Health 2 2010-10-01 2010-10-01 false Appeal of a categorization of a device. 405.753... Under Medicare Part A § 405.753 Appeal of a categorization of a device. (a) CMS's acceptance of the FDA categorization of a device as an experimental/investigational (Category A) device under § 405.203 is a national...

42 CFR 405.877 - Appeal of a categorization of a device.

Science.gov (United States)

2010-10-01

... 42 Public Health 2 2010-10-01 2010-10-01 false Appeal of a categorization of a device. 405.877... Part B Program § 405.877 Appeal of a categorization of a device. (a) CMS's acceptance of the FDA categorization of a device as an experimental/investigational (Category A) device under § 405.203 is a national...

Obstetrical and Gynecological Devices; Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair; Final order.

Science.gov (United States)

2016-01-05

The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify surgical mesh for transvaginal pelvic organ prolapse (POP) repair from class II to class III. FDA is reclassifying these devices based on the determination that general controls and special controls together are not sufficient to provide reasonable assurance of safety and effectiveness for this device, and these devices present a potential unreasonable risk of illness or injury. The Agency is reclassifying surgical mesh for transvaginal POP repair on its own initiative based on new information.

Gottlieb, the FDA and dumbing down medicine

Directory of Open Access Journals (Sweden)

Robbins RA

2017-04-01

Full Text Available No abstract available. Article truncated at 150 words. In the last few weeks several events have occurred that might impact drug approval in the US. President Donald Trump's pick for FDA commissioner, Dr. Scott Gottlieb. Gottlieb, like many of Trump’s picks for administration healthcare positions, is a physician. He also has experience as deputy FDA commissioner from 2005-7. However, his confirmation hearing before the Senate Committee on Health, Education, Labor and Pensions alarmed some who say his deep ties to the pharmaceutical industry will cause a conflict of interest (1. Others praised Gottlieb as the right man to lead the FDA. As opposed to Trump, Gottlieb denied any connection between vaccines and autism (1,2. Dr. Gottlieb called the issue "one of the most exhaustively studied questions in medical history," before saying, "There is no plausible link between vaccines and autism. At some point, we have to accept 'no' for an answer." However, Gottlieb did not give a straight …

Assurance Cases for Medical Devices

Science.gov (United States)

2011-04-28

the patient, and the hospital setting. Some pumps allow the patient to control part of the injection process (e.g. to inject more painkiller ...overdose, incorrect therapy, etc.   Design and development decisions that bear on safety and effectiveness http://www.fda.gov/MedicalDevices

Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Organophosphate Test System. Final order.

Science.gov (United States)

2017-10-18

The Food and Drug Administration (FDA or we) is classifying the organophosphate test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the organophosphate test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Medical Devices; Hematology and Pathology Devices; Classification of a Cervical Intraepithelial Neoplasia Test System. Final order.

Science.gov (United States)

2018-01-03

The Food and Drug Administration (FDA or we) is classifying the cervical intraepithelial neoplasia (CIN) test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the CIN test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

77 FR 8260 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device...

Science.gov (United States)

2012-02-14

... will be used to evaluate risks associated with medical devices which will enable FDA to take...] Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Reporting... comment in response to the notice. This notice solicits comments on medical device reporting (MDR...

75 FR 384 - Event Problem Codes Web Site; Center for Devices and Radiological Health; Availability

Science.gov (United States)

2010-01-05

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0576] Event Problem Codes Web Site; Center for Devices and Radiological Health; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

FDA Adverse Event Reporting System (FAERS): Latest Quartely Data Files

Data.gov (United States)

U.S. Department of Health & Human Services — The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse event and medication error reports submitted to FDA. The database...

Healthy public relations: the FDA's 1930s legislative campaign.

Science.gov (United States)

Kay, G

2001-01-01

In this article, I argue that the Food and Drug Administration (FDA) is an oft-overlooked government agency that acts to preserve and secure the public's health. From its early years as an agency charged with enforcement of the 1906 Pure Food and Drugs Act, the FDA not only protected the public's health but also made the public aware of its mission, using methods as diverse as displays at county fairs and at the 1933 Chicago World's Fair, radio programming, and active correspondence. The agency encouraged the public to protect itself, particularly in those arenas in which the FDA had no regulatory authority. In addition, it may have overstepped its boundaries when it actively solicited public support for a bill submitted to Congress in the early 1930s. In the dark days of the Great Depression, the FDA contended not only with limited resources and its own feelings of inadequacy in terms of what could and could not be done to protect the populace, but also with "guinea pig" books that horrified and angered many readers. By 1938, when the agency prevailed and the revisions to the 1906 Act passed Congress and were signed into law by President Franklin D. Roosevelt, the FDA had done all that a responsible public health agency should do, and more.

76 FR 47210 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

Science.gov (United States)

2011-08-04

... placed on the Internet. Section 10.33(b) provides that FDA may, for good cause, extend this 30-day period.......... Chestnut Medical Pipeline embolization device.... April 6, 2011. Technologies, Inc. P100034 FDA-2011-M-0295... Scientific Corp ION paclitaxel-eluting coronary April 22, 2011. stent system (monorail and over- the-wire...

Large-area high-efficiency flexible PHOLED lighting panels

Science.gov (United States)

Pang, Huiqing; Mandlik, Prashant; Levermore, Peter A.; Silvernail, Jeff; Ma, Ruiqing; Brown, Julie J.

2012-09-01

Organic Light Emitting Diodes (OLEDs) provide various attractive features for next generation illumination systems, including high efficiency, low power, thin and flexible form factor. In this work, we incorporated phosphorescent emitters and demonstrated highly efficient white phosphorescent OLED (PHOLED) devices on flexible plastic substrates. The 0.94 cm2 small-area device has total thickness of approximately 0.25 mm and achieved 63 lm/W at 1,000 cd/m2 with CRI = 85 and CCT = 2920 K. We further designed and fabricated a 15 cm x 15 cm large-area flexible white OLED lighting panels, finished with a hybrid single-layer ultra-low permeability single layer barrier (SLB) encapsulation film. The flexible panel has an active area of 116.4 cm2, and achieved a power efficacy of 47 lm/W at 1,000 cd/m2 with CRI = 83 and CCT = 3470 K. The efficacy of the panel at 3,000 cd/m2 is 43 lm/W. The large-area flexible PHOLED lighting panel is to bring out enormous possibilities to the future general lighting applications.

Medical Devices; Immunology and Microbiology Devices; Classification of the Assayed Quality Control Material for Clinical Microbiology Assays. Final order.

Science.gov (United States)

2017-07-27

The Food and Drug Administration (FDA, Agency, or we) is classifying the assayed quality control material for clinical microbiology assays into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the assayed quality control material for clinical microbiology assays' classification. The Agency is classifying the device into class II (special controls) to provide a reasonable assurance of safety and effectiveness of the device.

Use of Internet panels to conduct surveys.

Science.gov (United States)

Hays, Ron D; Liu, Honghu; Kapteyn, Arie

2015-09-01

The use of Internet panels to collect survey data is increasing because it is cost-effective, enables access to large and diverse samples quickly, takes less time than traditional methods to obtain data for analysis, and the standardization of the data collection process makes studies easy to replicate. A variety of probability-based panels have been created, including Telepanel/CentERpanel, Knowledge Networks (now GFK KnowledgePanel), the American Life Panel, the Longitudinal Internet Studies for the Social Sciences panel, and the Understanding America Study panel. Despite the advantage of having a known denominator (sampling frame), the probability-based Internet panels often have low recruitment participation rates, and some have argued that there is little practical difference between opting out of a probability sample and opting into a nonprobability (convenience) Internet panel. This article provides an overview of both probability-based and convenience panels, discussing potential benefits and cautions for each method, and summarizing the approaches used to weight panel respondents in order to better represent the underlying population. Challenges of using Internet panel data are discussed, including false answers, careless responses, giving the same answer repeatedly, getting multiple surveys from the same respondent, and panelists being members of multiple panels. More is to be learned about Internet panels generally and about Web-based data collection, as well as how to evaluate data collected using mobile devices and social-media platforms.

77 FR 66848 - Minimum Clinically Important Difference: An Outcome Metric in Orthopaedic Device Science and...

Science.gov (United States)

2012-11-07

...] Minimum Clinically Important Difference: An Outcome Metric in Orthopaedic Device Science and Regulation... Clinically Important Difference: An Outcome Metric in Orthopaedic Device Science and Regulation.'' FDA is co... (MCID) for patient-reported outcome (PRO) instruments used in orthopaedic extremity device-related...

78 FR 33849 - Battery-Powered Medical Devices Workshop: Challenges and Opportunities; Public Workshop; Request...

Science.gov (United States)

2013-06-05

... after the public workshop on the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/Workshops..., compact, and mobile, the number of battery-powered medical devices will continue to increase. While many...] Battery-Powered Medical Devices Workshop: Challenges and Opportunities; Public Workshop; Request for...

78 FR 12068 - Device Good Manufacturing Practice Advisory Committee; Notice of Meeting

Science.gov (United States)

2013-02-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Device Good Manufacturing Practice Advisory Committee; Notice of Meeting AGENCY: Food and Drug... Committee: Device Good Manufacturing Practice Advisory Committee. General Function of the Committee: To...

77 FR 16036 - Guidance for Industry, Third Parties and Food and Drug Administration Staff; Medical Device ISO...

Science.gov (United States)

2012-03-19

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0226...) audit report provides FDA a degree of assurance of compliance with basic and fundamental quality management system requirements for medical devices. \\1\\ The GHTF founding members auditing systems include...

Comparison of FDA safety and efficacy data for KAMRA and Raindrop corneal inlays

Directory of Open Access Journals (Sweden)

Majid Moshirfar

2017-09-01

Full Text Available AIM: To provide a side-by-side analysis of the summary of safety and effectiveness data (SSED submitted to the FDA for the KAMRA and Raindrop corneal inlays for the correction of presbyopia. METHODS: SSED reports submitted to the FDA for KAMRA and Raindrop were compared with respect to loss of corrected distance visual acuity (CDVA, adverse event rates, induction of astigmatism, retention of contrast sensitivity, stability of manifest refractive spherical equivalent (MRSE, and achieved monocular uncorrected near visual acuity (UNVA at 24mo. RESULTS: Totally 442/508 of KAMRA patients and 344/373 Raindrop patients remained enrolled in the clinical trials at 24mo. The proportion of KAMRA and Raindrop patients who lost ≥2 lines of CDVA at 24mo was 3.4% and 1%, respectively. The adverse event rate was comparable between the devices. No significant inductions of astigmatism were noted. Both technologies induced a transient myopic shift in MRSE followed by a hyperopic shift and subsequent stabilization. Totally 87% of KAMRA and 98% of Raindrop patients attained a monocular UNVA of J5 (20/40 or better at 24mo, 28% of KAMRA and 67% of Raindrop patients attained a monocular UNVA of J1 (20/20 or better at 24mo. CONCLUSION: Both devices can be considered safe and effective, however, the results of corneal inlay implantation are mixed, and long-term patient satisfaction will likely depend on subjective expectations about the capabilities of the inlays. Variability in surgical technique and postoperative care within and between the two clinical trials diminishes the comparative power of this article.

37 CFR 251.2 - Purpose of Copyright Arbitration Royalty Panels.

Science.gov (United States)

2010-07-01

... carrier royalty fees and digital audio recording devices and media payments deposited with the Register of... Arbitration Royalty Panels. 251.2 Section 251.2 Patents, Trademarks, and Copyrights COPYRIGHT OFFICE, LIBRARY OF CONGRESS COPYRIGHT ARBITRATION ROYALTY PANEL RULES AND PROCEDURES COPYRIGHT ARBITRATION ROYALTY...

Permitting product liability litigation for FDA-approved drugs and devices promotes patient safety.

Science.gov (United States)

Kesselheim, A S

2010-06-01

In 2008 and 2009, the Supreme Court reviewed the question of whether patients injured by dangerous prescription drugs or medical devices can bring tort lawsuits against pharmaceutical and device manufacturers. The Court ruled that claims against device manufacturers were preempted while claims against pharmaceutical manufacturers were not. The threat of product liability lawsuits promotes patient safety by encouraging manufacturers to take greater responsibility in providing clear warnings about known adverse effects of their products.

78 FR 79300 - Cardiovascular Devices; Reclassification of Intra-Aortic Balloon and Control Systems for Acute...

Science.gov (United States)

2013-12-30

.... FDA-2013-N-0581] Cardiovascular Devices; Reclassification of Intra-Aortic Balloon and Control Systems... of these devices into class II. List of Subjects in 21 CFR Part 870 Medical devices, Cardiovascular... Commissioner of Food and Drugs, 21 CFR part 870 is amended as follows: PART 870--CARDIOVASCULAR DEVICES 0 1...

78 FR 36702 - Cardiovascular Devices; Reclassification of Intra-Aortic Balloon and Control Systems (IABP) for...

Science.gov (United States)

2013-06-19

.... FDA-2013-N-0581] Cardiovascular Devices; Reclassification of Intra-Aortic Balloon and Control Systems... Device In the preamble to the proposed rule (44 FR 13369; March 9, 1979), the Cardiovascular Device... Bypass Grafting: A Propensity Score Analysis,'' Interactive Cardiovascular and Thoracic Surgery, vol. 9...

76 FR 43582 - Cardiovascular Devices; Classification of Electrocardiograph Electrodes

Science.gov (United States)

2011-07-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 870 [Docket No. FDA-2007-N-0092] (Formerly Docket No. 2007N-0308) Cardiovascular Devices; Classification of... amended as follows: [[Page 43585

Color quality management in advanced flat panel display engines

Science.gov (United States)

Lebowsky, Fritz; Neugebauer, Charles F.; Marnatti, David M.

2003-01-01

During recent years color reproduction systems for consumer needs have experienced various difficulties. In particular, flat panels and printers could not reach a satisfactory color match. The RGB image stored on an Internet server of a retailer did not show the desired colors on a consumer display device or printer device. STMicroelectronics addresses this important color reproduction issue inside their advanced display engines using novel algorithms targeted for low cost consumer flat panels. Using a new and genuine RGB color space transformation, which combines a gamma correction Look-Up-Table, tetrahedrization, and linear interpolation, we satisfy market demands.

FDA Approves First Therapeutic Cancer Vaccine

Science.gov (United States)

Sipuleucel-T (Provenge) is a relatively nontoxic treatment option for men with hormone-resistant or castration-resistant prostate cancer. The FDA's approval of the vaccine represented the first proof of principle that immunotherapy can work in cancer.

Embedded nonvolatile memory devices with various silicon nitride energy band gaps on glass used for flat panel display applications

International Nuclear Information System (INIS)

Son, Dang Ngoc; Van Duy, Nguyen; Jung, Sungwook; Yi, Junsin

2010-01-01

Nonvolatile memory (NVM) devices with a nitride–nitride–oxynitride stack structure on a rough poly-silicon (poly-Si) surface were fabricated using a low-temperature poly-Si (LTPS) thin film transistor technology on glass substrates for application of flat panel display (FPD). The plasma-assisted oxidation/nitridation method is used to form a uniform oxynitride with an ultrathin tunneling layer on a rough LTPS surface. The NVMs, using a Si-rich silicon nitride film as a charge-trapping layer, were proposed as one of the solutions for the improvement of device performance such as the program/erase speed, the memory window and the charge retention characteristics. To further improve the vertical scaling and charge retention characteristics of NVM devices, the high-κ high-density N-rich SiN x films are used as a blocking layer. The fabricated NVM devices have outstanding electrical properties, such as a low threshold voltage, a high ON/OFF current ratio, a low subthreshold swing, a low operating voltage of less than ±9 V and a large memory window of 3.7 V, which remained about 1.9 V over a period of 10 years. These characteristics are suitable for electrical switching and data storage with in FPD application

Mining FDA drug labels for medical conditions.

Science.gov (United States)

Li, Qi; Deleger, Louise; Lingren, Todd; Zhai, Haijun; Kaiser, Megan; Stoutenborough, Laura; Jegga, Anil G; Cohen, Kevin Bretonnel; Solti, Imre

2013-04-24

Cincinnati Children's Hospital Medical Center (CCHMC) has built the initial Natural Language Processing (NLP) component to extract medications with their corresponding medical conditions (Indications, Contraindications, Overdosage, and Adverse Reactions) as triples of medication-related information ([(1) drug name]-[(2) medical condition]-[(3) LOINC section header]) for an intelligent database system, in order to improve patient safety and the quality of health care. The Food and Drug Administration's (FDA) drug labels are used to demonstrate the feasibility of building the triples as an intelligent database system task. This paper discusses a hybrid NLP system, called AutoMCExtractor, to collect medical conditions (including disease/disorder and sign/symptom) from drug labels published by the FDA. Altogether, 6,611 medical conditions in a manually-annotated gold standard were used for the system evaluation. The pre-processing step extracted the plain text from XML file and detected eight related LOINC sections (e.g. Adverse Reactions, Warnings and Precautions) for medical condition extraction. Conditional Random Fields (CRF) classifiers, trained on token, linguistic, and semantic features, were then used for medical condition extraction. Lastly, dictionary-based post-processing corrected boundary-detection errors of the CRF step. We evaluated the AutoMCExtractor on manually-annotated FDA drug labels and report the results on both token and span levels. Precision, recall, and F-measure were 0.90, 0.81, and 0.85, respectively, for the span level exact match; for the token-level evaluation, precision, recall, and F-measure were 0.92, 0.73, and 0.82, respectively. The results demonstrate that (1) medical conditions can be extracted from FDA drug labels with high performance; and (2) it is feasible to develop a framework for an intelligent database system.

78 FR 58785 - Unique Device Identification System

Science.gov (United States)

2013-09-24

... the UDI system because they are controlled in the supply chain by the kit rather than by constituent... reduce existing obstacles to the adequate identification of medical devices used in the United States. By... stated, ``We support FDA's objective to substantially reduce existing obstacles to the adequate...

Environmental assessments and findings of no significant impact--FDA. Notice.

Science.gov (United States)

1998-05-18

The Food and Drug Administration (FDA) is announcing that it has reviewed environmental assessments (EA's) and issued findings of no significant impact (FONSI's) relating to the 167 new drug applications (NDA's) and supplemental applications listed in this document. FDA is publishing this notice because Federal regulations require public notice of the availability of environmental documents.

21 CFR 516.34 - FDA recognition of exclusive marketing rights.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 6 2010-04-01 2010-04-01 false FDA recognition of exclusive marketing rights. 516... SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES Designation of a Minor Use or Minor Species New Animal Drug § 516.34 FDA recognition of exclusive...

Guide to preemption of state-law claims against Class III PMA medical devices.

Science.gov (United States)

Whitney, Daniel W

2010-01-01

There is a perception that the express preemption holding of the Supreme Court in Riegel v. Medtronic, 552 U.S. 312(2008), immunizes medical device manufacturers from common law personal injury actions involving Class III devices that received FDA clearance under a premarket approval application (PMA). In the aftermath of Riegel, many lawsuits involving Class III PMA devices have been dismissed by district courts applying the new heightened pleading standard of Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007). Other lawsuits involving Class III PMA devices premised on fraud-on-FDA have been dismissed based on the implied preemption holding of the Supreme Court in Buckman v. Plaintiffs' Legal Comm., 531 U.S. 341 (2001). When these decisions are carefully analyzed together with Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), which found no preemption regarding a Class III device receiving FDA clearance through the 510(k) mechanism, it is apparent that the preemption defense does not apply universally to Class III PMA devices. The overall methodology for framing a non-preempted claim is to first identify conduct which violated the PMA or other specific requirements related to safety or efficacy. If such conduct can also be stated in terms of a breach of a parallel common law duty (e.g, failure to warn under strict liability or negligence, manufacturing defect or breach of warranty), then it would appear the claim is not preempted. Alternatively, regardless of a specific violation, common law remedies are not preempted by general CGMP requirements.

Formation of defect-free 6FDA-DAM asymmetric hollow fiber membranes for gas separations

KAUST Repository

Xu, Liren; Zhang, Chen; Rungta, Meha; Qiu, Wulin; Liu, Junqiang; Koros, William J.

2014-01-01

This paper reports the formation of defect-free 6FDA-DAM asymmetric hollow fiber membranes. 6FDA-polyimides are of great interest for advanced gas separation membranes, and 6FDA-DAM polyimide is a representative polymer in this family

Gas separation performance of 6FDA-based polyimides with different chemical structures

KAUST Repository

Qiu, Wulin

2013-10-01

This work reports the gas separation performance of several 6FDA-based polyimides with different chemical structures, to correlate chemical structure with gas transport properties with a special focus on CO2 and CH 4 transport and plasticization stability of the polyimides membranes relevant to natural gas purification. The consideration of the other gases (He, O2 and N2) provided additional insights regarding effects of backbone structure on detailed penetrant properties. The polyimides studied include 6FDA-DAM, 6FDA-mPDA, 6FDA-DABA, 6FDA-DAM:DABA (3:2), 6FDA-DAM:mPDA (3:2) and 6FDA-mPDA:DABA (3:2). Both pure and binary gas permeation were investigated. The packing density, which is tunable by adjusting monomer type and composition of the various samples, correlated with transport permeability and selectivity. The separation performance of the polyimides for various gas pairs were also plotted for comparison to the upper bound curves, and it was found that this family of materials shows attractive performance. The CO 2 plasticization responses for the un-cross-linked polyimides showed good plasticization resistance to CO2/CH4 mixed gas with 10% CO2; however, only the cross-linked polyimides showed good plasticization resistance under aggressive gas feed conditions (CO 2/CH4 mixed gas with 50% CO2 or pure CO 2). For future work, asymmetric hollow fibers and carbon molecular sieve membranes based on the most attractive members of the family will be considered. © 2013 Elsevier Ltd. All rights reserved.

FDA Proposes New Safety Measures for Indoor Tanning Devices: The Facts

Science.gov (United States)

... Related Consumer Updates Indoor Tanning: The Risks of Ultraviolet Rays 5 Tips for a Healthy Vacation More in Consumer Updates Animal & Veterinary Children's Health Cosmetics Dietary Supplements Drugs Food Medical Devices Nutrition Radiation-Emitting Products Tobacco Products ...

Formation of defect-free 6FDA-DAM asymmetric hollow fiber membranes for gas separations

KAUST Repository

Xu, Liren

2014-06-01

This paper reports the formation of defect-free 6FDA-DAM asymmetric hollow fiber membranes. 6FDA-polyimides are of great interest for advanced gas separation membranes, and 6FDA-DAM polyimide is a representative polymer in this family with attractive dense film properties for several potential applications. The work reported here for the 6FDA-DAM polyimide provides insight for the challenging fabrication of defect-free asymmetric hollow fiber membranes for this class of 6FDA-polyimides, which behave rather different from lower free volume polymers. Specifically, the 6FDA based materials show relatively slow phase separation rate in water quench baths, which presents a challenge for fiber spinning. For convenience, we refer to the behavior as more "non-solvent resistant" in comparison to other lower free volume polymers, since the binodal phase boundary is displaced further from the conventional position near the pure polymer-solvent axis on a ternary phase diagram in conventional polymers like Matrimid® and Ultem®. The addition of lithium nitrate to promote phase separation has a useful impact on 6FDA-DAM asymmetric hollow fiber formation. 6FDA-DAM phase diagrams using ethanol and water as non-solvent are reported, and it was found that water is less desirable as a non-solvent dope additive for defect-free fiber spinning. Phase diagrams are also reported for 6FDA-DAM dope formulation with and without the addition of lithium nitrate, and defect-free asymmetric hollow fiber membranes are reported for both cases. The effect of polymer molecular weight on defect-free fiber spinning was also investigated. Gas transport properties and morphology of hollow fibers were characterized. With several thorough case studies, this work provides a systematic guideline for defect-free fiber formation from 6FDA-polymers. © 2014 Elsevier B.V.

Medical Devices; Obstetrical and Gynecological Devices; Classification of the Pressure Wedge for the Reduction of Cesarean Delivery. Final order.

Science.gov (United States)

2017-12-28

The Food and Drug Administration (FDA or we) is classifying the pressure wedge for the reduction of cesarean delivery into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the pressure wedge for the reduction of cesarean delivery's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

An FDA-Drug Library Screen for Compounds with Bioactivities against Meticillin-Resistant Staphylococcus aureus (MRSA

Directory of Open Access Journals (Sweden)

Qiu Ying Lau

2015-10-01

Full Text Available The lack of new antibacterial drugs entering the market and their misuse have resulted in the emergence of drug-resistant bacteria, posing a major health crisis worldwide. In particular, meticillin-resistant Staphylococcus aureus (MRSA, a pathogen responsible for numerous human infections, has become endemic in hospitals worldwide. Drug repurposing, the finding of new therapeutic indications for approved drugs, is deemed a plausible solution to accelerate drug discovery and development in this area. Towards this end, we screened 1163 drugs approved by the Food and Drug Administration (FDA for bioactivities against MRSA in a 10 μM single-point assay. After excluding known antibiotics and antiseptics, six compounds were identified and their MICs were determined against a panel of clinical MRSA strains. A toxicity assay using human keratinocytes was also conducted to gauge their potential for repurposing as topical agents for treating MRSA skin infections.

Analysis of lomustine drug content in FDA-approved and compounded lomustine capsules.

Science.gov (United States)

KuKanich, Butch; Warner, Matt; Hahn, Kevin

2017-02-01

OBJECTIVE To determine the lomustine content (potency) in compounded and FDA-approved lomustine capsules. DESIGN Evaluation study. SAMPLE 2 formulations of lomustine capsules (low dose [7 to 11 mg] and high dose [40 to 48 mg]; 5 capsules/dose/source) from 3 compounders and from 1 manufacturer of FDA-approved capsules. PROCEDURES Lomustine content was measured by use of a validated high-pressure liquid chromatography method. An a priori acceptable range of 90% to 110% of the stated lomustine content was selected on the basis of US Pharmacopeia guidelines. RESULTS The measured amount of lomustine in all compounded capsules was less than the stated content (range, 59% to 95%) and was frequently outside the acceptable range (failure rate, 2/5 to 5/5). Coefficients of variation for lomustine content ranged from 4.1% to 16.7% for compounded low-dose capsules and from 1.1% to 10.8% for compounded high-dose capsules. The measured amount of lomustine in all FDA-approved capsules was slightly above the stated content (range, 104% to 110%) and consistently within the acceptable range. Coefficients of variation for lomustine content were 0.5% for low-dose and 2.3% for high-dose FDA-approved capsules. CONCLUSIONS AND CLINICAL RELEVANCE Compounded lomustine frequently did not contain the stated content of active drug and had a wider range of lomustine content variability than did the FDA-approved product. The sample size was small, and larger studies are needed to confirm these findings; however, we recommend that compounded veterinary formulations of lomustine not be used when appropriate doses can be achieved with FDA-approved capsules or combinations of FDA-approved capsules.

Advancing Product Quality: a Summary of the Inaugural FDA/PQRI Conference.

Science.gov (United States)

Yu, Lawrence X; Baker, Jeffrey; Berlam, Susan C; Boam, Ashley; Brandreth, E J; Buhse, Lucinda; Cosgrove, Thomas; Doleski, David; Ensor, Lynne; Famulare, Joseph; Ganapathy, Mohan; Grampp, Gustavo; Hussong, David; Iser, Robert; Johnston, Gordon; Kesisoglou, Filippos; Khan, Mansoor; Kozlowski, Steven; Lacana, Emanuela; Lee, Sau L; Miller, Stephen; Miksinski, Sarah Pope; Moore, Christine M V; Mullin, Theresa; Raju, G K; Raw, Andre; Rosencrance, Susan; Rosolowsky, Mark; Stinavage, Paul; Thomas, Hayden; Wesdyk, Russell; Windisch, Joerg; Vaithiyalingam, Sivakumar

2015-07-01

On September 16 and 17, 2014, the Food and Drug Administration (FDA) and Product Quality Research Institute (PQRI) inaugurated their Conference on Evolving Product Quality. The Conference is conceived as an annual forum in which scientists from regulatory agencies, industry, and academia may exchange viewpoints and work together to advance pharmaceutical quality. This Conference Summary Report highlights key topics of this conference, including (1) risk-based approaches to pharmaceutical development, manufacturing, regulatory assessment, and post-approval changes; (2) FDA-proposed quality metrics for products, facilities, and quality management systems; (3) performance-based quality assessment and clinically relevant specifications; (4) recent developments and implementation of continuous manufacturing processes, question-based review, and European Medicines Agency (EMA)-FDA pilot for Quality-by-Design (QbD) applications; and (5) breakthrough therapies, biosimilars, and international harmonization, focusing on ICH M7 and Q3D guidelines. The second FDA/PQRI conference on advancing product quality is planned for October 5-7, 2015.

FDA-approved small-molecule kinase inhibitors

DEFF Research Database (Denmark)

Wu, Peng; Nielsen, Thomas E.; Clausen, Mads Hartvig

2015-01-01

Kinases have emerged as one of the most intensivelypursued targets in current pharmacological research,especially for cancer, due to their critical roles in cellularsignaling. To date, the US FDA has approved 28 smallmoleculekinase inhibitors, half of which were approvedin the past 3 years. While...

77 FR 40735 - Unique Device Identification System

Science.gov (United States)

2012-07-10

... lessons learned from these pilot activities. FDA also solicited input through public meetings; a public... used to identify devices, and no assurance that different companies are using a given term in the same... weaknesses or problems in our implementation of the UDI system and to make appropriate mid-course corrections...

Could FDA approval of pre-exposure prophylaxis make a difference? A qualitative study of PrEP acceptability and FDA perceptions among men who have sex with men.

Science.gov (United States)

Underhill, Kristen; Morrow, Kathleen M; Operario, Don; Mayer, Kenneth H

2014-02-01

The FDA has approved tenofovir-emtricitabine for use as HIV pre-exposure prophylaxis, but it is unknown how approval may affect PrEP acceptability among US men who have sex with men. We conducted 8 focus groups among 38 Rhode Island MSM, including 3 groups among 16 male sex workers and 5 groups among 22 men in the general MSM community. Participants reported wide-ranging beliefs regarding consequences and meanings of FDA approval. Some participants would not use PrEP without approval, while others perceived approval as irrelevant or less significant than other sources of information. Our results suggest that FDA approval sends a signal that directly shapes PrEP acceptability among some MSM, while indirect influences of approval may affect uptake by others. Efforts to educate MSM about PrEP can increase acceptability by incorporating information about FDA approval, and outreach strategies should consider how this information may factor into personal decisions about PrEP use.

Innovative postmarket device evaluation using a quality registry to monitor thoracic endovascular aortic repair in the treatment of aortic dissection.

Science.gov (United States)

Beck, Adam W; Lombardi, Joseph V; Abel, Dorothy B; Morales, J Pablo; Marinac-Dabic, Danica; Wang, Grace; Azizzadeh, Ali; Kern, John; Fillinger, Mark; White, Rodney; Cronenwett, Jack L; Cambria, Richard P

2017-05-01

United States Food and Drug Administration (FDA)-mandated postapproval studies have long been a mainstay of the continued evaluation of high-risk medical devices after initial marketing approval; however, these studies often present challenges related to patient/physician recruitment and retention. Retrospective single-center studies also do not fully represent the spectrum of real-world performance nor are they likely to have a sufficiently large enough sample size to detect important signals. In recent years, The FDA Center for Devices and Radiological Health has been promoting the development and use of patient registries to advance infrastructure and methodologies for medical device investigation. The FDA 2012 document, "Strengthening the National System for Medical Device Post-market Surveillance," highlighted registries as a core foundational infrastructure when linked to other complementary data sources, including embedded unique device identification. The Vascular Quality Initiative (VQI) thoracic endovascular aortic repair for type B aortic dissection project is an innovative method of using quality improvement registries to meet the needs of device evaluation after market approval. Here we report the organization and background of this project and highlight the innovation facilitated by collaboration of physicians, the FDA, and device manufacturers. This effort used an existing national network of VQI participants to capture patients undergoing thoracic endovascular aortic repair for acute type B aortic dissection within a registry that aligns with standard practice and existing quality efforts. The VQI captures detailed patient, device, and procedural data for consecutive eligible cases under the auspices of a Patient Safety Organization (PSO). Patients were divided into a 5-year follow-up group (200 acute; 200 chronic dissections) and a 1-year follow-up group (100 acute; 100 chronic). The 5-year cohort required additional imaging details, and the 1-year

Hypnotic Medications and Suicide: Risk, Mechanisms, Mitigation, and the FDA.

Science.gov (United States)

McCall, W Vaughn; Benca, Ruth M; Rosenquist, Peter B; Riley, Mary Anne; McCloud, Laryssa; Newman, Jill C; Case, Doug; Rumble, Meredith; Krystal, Andrew D

2017-01-01

Insomnia is associated with increased risk for suicide. The Food and Drug Administration (FDA) has mandated that warnings regarding suicide be included in the prescribing information for hypnotic medications. The authors conducted a review of the evidence for and against the claim that hypnotics increase the risk of suicide. This review focused on modern, FDA-approved hypnotics, beginning with the introduction of benzodiazepines, limiting its findings to adults. PubMed and Web of Science were searched, crossing the terms "suicide" and "suicidal" with each of the modern FDA-approved hypnotics. The FDA web site was searched for postmarketing safety reviews, and the FDA was contacted with requests to provide detailed case reports for hypnotic-related suicide deaths reported through its Adverse Event Reporting System. Epidemiological studies show that hypnotics are associated with an increased risk for suicide. However, none of these studies adequately controlled for depression or other psychiatric disorders that may be linked with insomnia. Suicide deaths have been reported from single-agent hypnotic overdoses. A separate concern is that benzodiazepine receptor agonist hypnotics can cause parasomnias, which in rare cases may lead to suicidal ideation or suicidal behavior in persons who were not known to be suicidal. On the other hand, ongoing research is testing whether treatment of insomnia may reduce suicidality in adults with depression. The review findings indicate that hypnotic medications are associated with suicidal ideation. Future studies should be designed to assess whether increases in suicidality result from CNS impairments from a given hypnotic medication or whether such medication decreases suicidality because of improvements in insomnia.

Regulation and Device Development: Tips for Optimizing Your Experience With the Food and Drug Administration.

Science.gov (United States)

Brooks, Steven S

2017-06-01

Physician-inventors are in a unique position to identify unserved patient needs, and innovate solutions to clinical problems. These solutions may also have associated commercial opportunities. The logistics of developing these medical products, however, can seem a daunting task. One of the primary barriers in the United States is the regulatory process of the Food and Drug Administration (FDA). In this article, we will explore the risk-based approach used by the FDA which forms a framework to consider the regulatory pathway and the process to gain regulatory clearance or approval for medical devices. Inherent device properties and the procedural risk of the devices will determine the rigor with which they are scrutinized by FDA, and the evidentiary requirements to legally market them. Data and evidentiary development will vary depending on risk and regulatory precedent and may or may not require clinical data This regulatory paradigm will determine into which risk-based device class they fit, and whether they are regulated under the 510(k) or premarket approval application pathways. The FDA, although gatekeeper of the US market and tasked with determining which products are safe and effective, can be a powerful ally for product development. They have significant scientific and medical expertise, and mechanisms to both provide guidance, and also to consider novel approaches to product development and evidence development. Early interaction for routine and novel products alike can result in expedited and efficient development. This collaborative approach can be best practice to most expeditiously develop the next generation of products, getting them into the hands of US doctors and into the treatment of US patients. Copyright © 2017. Published by Elsevier Inc.

Endoscopic Devices for Obesity.

Science.gov (United States)

Sampath, Kartik; Dinani, Amreen M; Rothstein, Richard I

2016-06-01

The obesity epidemic, recognized by the World Health Organization in 1997, refers to the rising incidence of obesity worldwide. Lifestyle modification and pharmacotherapy are often ineffective long-term solutions; bariatric surgery remains the gold standard for long-term obesity weight loss. Despite the reported benefits, it has been estimated that only 1% of obese patients will undergo surgery. Endoscopic treatment for obesity represents a potential cost-effective, accessible, minimally invasive procedure that can function as a bridge or alternative intervention to bariatric surgery. We review the current endoscopic bariatric devices including space occupying devices, endoscopic gastroplasty, aspiration technology, post-bariatric surgery endoscopic revision, and obesity-related NOTES procedures. Given the diverse devices already FDA approved and in development, we discuss the future directions of endoscopic therapies for obesity.

Evaluating eating behavior treatments by FDA standards

Directory of Open Access Journals (Sweden)

A. Janet eTomiyama

2014-01-01

Full Text Available Behavioral treatments for obesity are not evaluated by the same criteria as pharmaceutical drugs, even though treatments such as low-calorie dieting are widely prescribed, require the patients’ time and investment, and may have risks. The Food and Drug Administration (FDA has a procedure for evaluating drugs, in which drugmakers must answer the following questions: (1 Is the treatment safe? (2 How dangerous is the condition the intervention is treating? (3 Is the treatment effective? (4 Is the treatment safe and effective for large numbers of people? We argue that using this framework to evaluate behavioral interventions could help identify unanswered research questions on their efficacy and effectiveness, and we use the example of low-calorie dieting to illustrate how FDA criteria might be applied in the context of behavioral medicine.

77 FR 70449 - Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal...

Science.gov (United States)

2012-11-26

... and Drug Administration (FDA) is announcing the Web site location where the Agency will post two lists... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-1021] Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal Year 2013...

76 FR 61367 - Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal...

Science.gov (United States)

2011-10-04

.... ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the Web site location where... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-N-0270; formerly Docket No. 2007N-0357] Medical Device User Fee and Modernization Act; Notice to Public of Web Site...

78 FR 66746 - Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal...

Science.gov (United States)

2013-11-06

... and Drug Administration (FDA or the Agency) is announcing the Web site location where the Agency will... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-1021] Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal Year 2014...

78 FR 4094 - Effective Date of Requirement for Premarket Approval for Two Class III Preamendments Devices

Science.gov (United States)

2013-01-18

... devices. On August 8, 2001, the Orthopaedic and Rehabilitation Devices Panel (the Panel) recommended five... function due to excessive wear, fracture, deformation of the device components, or loosening of the device... excessive wear, fracture, deformation of the device components, or loosening of the device in the surgical...

Interfacial Crack Arrest in Sandwich Panels with Embedded Crack Stoppers Subjected to Fatigue Loading

DEFF Research Database (Denmark)

Martakos, G.; Andreasen, J. H.; Berggreen, Christian

2017-01-01

A novel crack arresting device has been implemented in sandwich panels and tested using a special rig to apply out-of-plane loading on the sandwich panel face-sheets. Fatigue crack propagation was induced in the face-core interface of the sandwich panels which met the crack arrester. The effect o...

Access to Investigational Drugs: FDA Expanded Access Programs or "Right-to-Try" Legislation?

Science.gov (United States)

Holbein, M E Blair; Berglund, Jelena P; Weatherwax, Kevin; Gerber, David E; Adamo, Joan E

2015-10-01

The Food and Drug Administration Expanded Access (EA) program and "Right-to-Try" legislation aim to provide seriously ill patients who have no other comparable treatment options to gain access to investigational drugs and biological agents. Physicians and institutions need to understand these programs to respond to questions and requests for access. FDA EA programs and state and federal legislative efforts to provide investigational products to patients by circumventing FDA regulations were summarized and compared. The FDA EA program includes Single Patient-Investigational New Drug (SP-IND), Emergency SP-IND, Intermediate Sized Population IND, and Treatment IND. Approval rates for all categories exceed 99%. Approval requires FDA and Institutional Review Board (IRB) approval, and cooperation of the pharmaceutical partner is essential. "Right-to-Try" legislation bypasses some of these steps, but provides no regulatory or safety oversight. The FDA EA program is a reasonable option for patients for whom all other therapeutic interventions have failed. The SP-IND not only provides patient access to new drugs, but also maintains a balance between immediacy and necessary patient protection. Rather than circumventing existing FDA regulations through proposed legislation, it seems more judicious to provide the knowledge and means to meet the EA requirements. © 2015 Wiley Periodicals, Inc.

76 FR 48715 - Immunology and Microbiology Devices; Reclassification of the Herpes Simplex Virus Serological...

Science.gov (United States)

2011-08-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2010-N-0429] Immunology and Microbiology Devices; Reclassification of the Herpes Simplex Virus... CFR part 866 is amended as follows: PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES 0 1. The authority...

76 FR 30175 - Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by...

Science.gov (United States)

2011-05-24

... consider public release of financial disclosure information related to an approved marketing application...] (Formerly FDA-1999-D-0792) Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial... entitled ``Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical...

76 FR 12742 - Guidance for Industry and Food and Drug Administration Staff; Clinical Investigations of Devices...

Science.gov (United States)

2011-03-08

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0457] Guidance for Industry and Food and Drug Administration Staff; Clinical Investigations of Devices Indicated... other electrical continence devices; protective garment for incontinence; surgical mesh; electrosurgical...

76 FR 22805 - Medical Devices; Reclassification of the Topical Oxygen Chamber for Extremities

Science.gov (United States)

2011-04-25

... 1976 Amendments (Pub. L. 94-295), the SMDA (Pub. L. 101-629), and the FDAMA (Pub. L. 105-115... Plastic Surgery Devices Panel (GPS Panel) for their recommendation on the requested reclassification. At a public meeting on November 17, 1998, the GPS Panel recommended that the device be retained in class III...

FDA actions against health economic promotions, 2002-2011.

Science.gov (United States)

Neumann, Peter J; Bliss, Sarah K

2012-01-01

To investigate Food and Drug Administration (FDA) regulatory actions against drug companies' health economic promotions from 2002 through 2011 to understand how frequently and in what circumstances the agency has considered such promotions false or misleading. We reviewed all warning letters and notices of violation ("untitled letters") issued by the FDA's Division of Drug Marketing, Advertising and Communications (DDMAC) to pharmaceutical companies from January 2002 through December 2011. We analyzed letters containing a violation related to "health economic promotion," defined according to one of several categories (e.g., implied claims of cost savings due to work productivity or economic claims containing unsupported statements about effectiveness or safety). We also collected information on factors such as the indication and type of media involved and whether the letter referenced Section 114 of the Food and Drug Administration Modernization Act. Of 291 DDMAC letters sent to pharmaceutical companies during the study period, 35 (12%) cited a health economic violation. The most common type of violation cited was an implied claim of cost savings due to work productivity or functioning (found in 20 letters) and economic claims containing unsubstantiated comparative claims of effectiveness, safety, or interchangeability (7 letters). The violations covered various indications, mostly commonly psychiatric disorders (6 letters) and pain (6 letters). No DDMAC letter pertained to Food and Drug Administration Modernization Act Section 114. The FDA has cited inappropriate health economic promotions in roughly 12% of the letters issued by the DDMAC. The letters highlight drug companies' interest in promoting the value of their products and the FDA's concerns in certain cases about the lack of supporting evidence. Copyright © 2012 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

75 FR 59670 - Immunology and Microbiology Devices; Reclassification of the Herpes Simplex Virus Serological...

Science.gov (United States)

2010-09-28

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2010-N-0429] Immunology and Microbiology Devices; Reclassification of the Herpes Simplex Virus... proposed that 21 CFR part 866 be amended as follows: PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES 1. The...

Semiconductor-based, large-area, flexible, electronic devices

Science.gov (United States)

Goyal, Amit [Knoxville, TN

2011-03-15

Novel articles and methods to fabricate the same resulting in flexible, large-area, triaxially textured, single-crystal or single-crystal-like, semiconductor-based, electronic devices are disclosed. Potential applications of resulting articles are in areas of photovoltaic devices, flat-panel displays, thermophotovoltaic devices, ferroelectric devices, light emitting diode devices, computer hard disc drive devices, magnetoresistance based devices, photoluminescence based devices, non-volatile memory devices, dielectric devices, thermoelectric devices and quantum dot laser devices.

A review of sensing technologies for small and large-scale touch panels

Science.gov (United States)

Akhtar, Humza; Kemao, Qian; Kakarala, Ramakrishna

2017-06-01

A touch panel is an input device for human computer interaction. It consists of a network of sensors, a sampling circuit and a micro controller for detecting and locating a touch input. Touch input can come from either finger or stylus depending upon the type of touch technology. These touch panels provide an intuitive and collaborative workspace so that people can perform various tasks with the use of their fingers instead of traditional input devices like keyboard and mouse. Touch sensing technology is not new. At the time of this writing, various technologies are available in the market and this paper reviews the most common ones. We review traditional designs and sensing algorithms for touch technology. We also observe that due to its various strengths, capacitive touch will dominate the large-scale touch panel industry in years to come. In the end, we discuss the motivation for doing academic research on large-scale panels.

Classification and evaluation of medical devices

Directory of Open Access Journals (Sweden)

Edina Vranić

2003-05-01

Full Text Available Medical devices and medical disposables contribute significantly to the quality and effectiveness of the health care system. It is necessary to commit scientifically sound regulatory environment that will provide consumers with the best medical care. This includes continued services to small manufacturers, readily available guidance on FDA requirements, predictable and reasonable response times on applications for marketing, and equitable enforcement. But in the public interest, this commitment to the industry must be coupled with a reciprocal commitment: that medical device firms will meet high standards in the design, manufacture, and evaluation of their products. The protections afforded our consumer, and the benefits provided the medical device industry, cannot be underestimated.

75 FR 17143 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

Science.gov (United States)

2010-04-05

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0495] Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Documents; Availability AGENCY: Food and Drug Administration, HHS. ACTION...

75 FR 44267 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

Science.gov (United States)

2010-07-28

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0495] Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening of Comment Period AGENCY: Food and Drug...

75 FR 20854 - Medical Device Use in the Home Environment: Implications for the Safe and Effective Use of...

Science.gov (United States)

2010-04-21

...] Medical Device Use in the Home Environment: Implications for the Safe and Effective Use of Medical Device... related to the safe and effective use of medical device technology in the home environment. The workshop... the home environment. FDA will solicit feedback on: 1. The agency's current working definition of...

FDA regulations for commercial food irradiation

International Nuclear Information System (INIS)

Takeguchi, C.A.

1985-01-01

The Food and Drug Administration published an Advance Notice of Proposed Rulemaking (ANPR) on food irradiation on March 27, 1981 (FDA, 1981). The next step in the rulemaking process is a proposed rule that will deal with low-dose irradiation of certain foods and high-dose irradiation of spices. The status of the proposed regulation is discussed

Time-Resolved Particle Image Velocimetry Measurements with Wall Shear Stress and Uncertainty Quantification for the FDA Nozzle Model.

Science.gov (United States)

Raben, Jaime S; Hariharan, Prasanna; Robinson, Ronald; Malinauskas, Richard; Vlachos, Pavlos P

2016-03-01

We present advanced particle image velocimetry (PIV) processing, post-processing, and uncertainty estimation techniques to support the validation of computational fluid dynamics analyses of medical devices. This work is an extension of a previous FDA-sponsored multi-laboratory study, which used a medical device mimicking geometry referred to as the FDA benchmark nozzle model. Experimental measurements were performed using time-resolved PIV at five overlapping regions of the model for Reynolds numbers in the nozzle throat of 500, 2000, 5000, and 8000. Images included a twofold increase in spatial resolution in comparison to the previous study. Data was processed using ensemble correlation, dynamic range enhancement, and phase correlations to increase signal-to-noise ratios and measurement accuracy, and to resolve flow regions with large velocity ranges and gradients, which is typical of many blood-contacting medical devices. Parameters relevant to device safety, including shear stress at the wall and in bulk flow, were computed using radial basis functions. In addition, in-field spatially resolved pressure distributions, Reynolds stresses, and energy dissipation rates were computed from PIV measurements. Velocity measurement uncertainty was estimated directly from the PIV correlation plane, and uncertainty analysis for wall shear stress at each measurement location was performed using a Monte Carlo model. Local velocity uncertainty varied greatly and depended largely on local conditions such as particle seeding, velocity gradients, and particle displacements. Uncertainty in low velocity regions in the sudden expansion section of the nozzle was greatly reduced by over an order of magnitude when dynamic range enhancement was applied. Wall shear stress uncertainty was dominated by uncertainty contributions from velocity estimations, which were shown to account for 90-99% of the total uncertainty. This study provides advancements in the PIV processing methodologies over

Humanitarian Use Device and Humanitarian Device Exemption regulatory programs: pros and cons.

Science.gov (United States)

Bernad, Daniel Maxwell

2009-03-01

The US FDA established the Humanitarian Use Device (HUD) and Humanitarian Device Exemption (HDE) program to encourage medical device firms to address rare diseases. Despite being in existence for over a decade, there has only been one peer-reviewed publication examining this field. The objective of this report is to investigate how the HUD/HDE program differs from the standard regulatory system, discuss its potential advantages and disadvantages, and to speculate which humanitarian devices will be brought to market within the next 5 years. A total of 40 semistructured interviews with stakeholders, representing approximately half (n = 20, 49%) of the firms that have successfully obtained HDE-approved products, were performed in order to acquire the primary data for this paper. There appear to be short-term gains and long-term drains associated with launching humanitarian devices to market. This report aims to provide sponsors with information that may allow them to make better decisions during their product development of humanitarian devices and may, hopefully, also play a role in encouraging other sponsors to take the necessary steps forward in helping to find treatments for patients with rare diseases.

Product-based Safety Certification for Medical Devices Embedded Software.

Science.gov (United States)

Neto, José Augusto; Figueiredo Damásio, Jemerson; Monthaler, Paul; Morais, Misael

2015-01-01

Worldwide medical device embedded software certification practices are currently focused on manufacturing best practices. In Brazil, the national regulatory agency does not hold a local certification process for software-intensive medical devices and admits international certification (e.g. FDA and CE) from local and international industry to operate in the Brazilian health care market. We present here a product-based certification process as a candidate process to support the Brazilian regulatory agency ANVISA in medical device software regulation. Center of Strategic Technology for Healthcare (NUTES) medical device embedded software certification is based on a solid safety quality model and has been tested with reasonable success against the Class I risk device Generic Infusion Pump (GIP).

FDA Regulation of Clinical Applications of CRISPR-CAS Gene-Editing Technology.

Science.gov (United States)

Grant, Evita V

Scientists have repurposed an adaptive immune system of single cell organisms to create a new type of gene-editing tool: CRISPR (clustered regularly interspaced short palindromic repeats)-Cas technology. Scientists in China have reported its use in the genome modification of non-viable human embryos. This has ignited a spirited debate about the moral, ethical, scientific, and social implications of human germline genome engineering. There have also been calls for regulations; however, FDA has yet to formally announce its oversight of clinical applications of CRISPR-Cas systems. This paper reviews FDA regulation of previously controversial biotechnology breakthroughs, recombinant DNA and human cloning. It then shows that FDA is well positioned to regulate CRISPR-Cas clinical applications, due to its legislative mandates, its existing regulatory frameworks for gene therapies and assisted reproductive technologies, and other considerations.

Access to Investigational Drugs: FDA Expanded Access Programs or “Right‐to‐Try” Legislation?

Science.gov (United States)

Berglund, Jelena P.; Weatherwax, Kevin; Gerber, David E.; Adamo, Joan E.

2015-01-01

Abstract Purpose The Food and Drug Administration Expanded Access (EA) program and “Right‐to‐Try” legislation aim to provide seriously ill patients who have no other comparable treatment options to gain access to investigational drugs and biological agents. Physicians and institutions need to understand these programs to respond to questions and requests for access. Methods FDA EA programs and state and federal legislative efforts to provide investigational products to patients by circumventing FDA regulations were summarized and compared. Results The FDA EA program includes Single Patient‐Investigational New Drug (SP‐IND), Emergency SP‐IND, Intermediate Sized Population IND, and Treatment IND. Approval rates for all categories exceed 99%. Approval requires FDA and Institutional Review Board (IRB) approval, and cooperation of the pharmaceutical partner is essential. “Right‐to‐Try” legislation bypasses some of these steps, but provides no regulatory or safety oversight. Conclusion The FDA EA program is a reasonable option for patients for whom all other therapeutic interventions have failed. The SP‐IND not only provides patient access to new drugs, but also maintains a balance between immediacy and necessary patient protection. Rather than circumventing existing FDA regulations through proposed legislation, it seems more judicious to provide the knowledge and means to meet the EA requirements. PMID:25588691

Global Proteome Analysis of the NCI-60 Cell Line Panel

Directory of Open Access Journals (Sweden)

Amin Moghaddas Gholami

2013-08-01

Full Text Available The NCI-60 cell line collection is a very widely used panel for the study of cellular mechanisms of cancer in general and in vitro drug action in particular. It is a model system for the tissue types and genetic diversity of human cancers and has been extensively molecularly characterized. Here, we present a quantitative proteome and kinome profile of the NCI-60 panel covering, in total, 10,350 proteins (including 375 protein kinases and including a core cancer proteome of 5,578 proteins that were consistently quantified across all tissue types. Bioinformatic analysis revealed strong cell line clusters according to tissue type and disclosed hundreds of differentially regulated proteins representing potential biomarkers for numerous tumor properties. Integration with public transcriptome data showed considerable similarity between mRNA and protein expression. Modeling of proteome and drug-response profiles for 108 FDA-approved drugs identified known and potential protein markers for drug sensitivity and resistance. To enable community access to this unique resource, we incorporated it into a public database for comparative and integrative analysis (http://wzw.tum.de/proteomics/nci60.

A Novel Lighting OLED Panel Design

Directory of Open Access Journals (Sweden)

Enyang Zhang

2016-11-01

Full Text Available A novel OLED (organic light emitting diode lighting panel, which uses a special layout design, can reduce the photolithography cycles and process costs and is more reliable. It only needs two steps of photolithography cycles, which include an ITO (InSnO compound transparent oxide pattern and insulator pattern. There is no need for the metal bus pattern of the ordinary design. The OLED device structure is a type of red–green–blue (RGB-stacked emitting layer that has a good color index and greater adjustability, which improves the performance of the device. This novel design has the same equipment and material requirement compared to the ordinary design, and it is very beneficial in terms of high volume and low-cost production. It uses a hyper driving method because the entire OLED lighting panel is divided into many sub-emitting units; if one of the sub-emitting units is burned out, it has no effect on the adjacent sub-emitting unit, so the reliability is markedly better than the ordinary design.

Small-molecule kinase inhibitors: an analysis of FDA-approved drugs

DEFF Research Database (Denmark)

Wu, Peng; Nielsen, Thomas Eiland; Clausen, Mads Hartvig

2016-01-01

Small-molecule kinase inhibitors (SMKIs), 28 of which are approved by the US Food and Drug Administration (FDA), have been actively pursued as promising targeted therapeutics. Here, we assess the key structural and physicochemical properties, target selectivity and mechanism of function, and ther......Small-molecule kinase inhibitors (SMKIs), 28 of which are approved by the US Food and Drug Administration (FDA), have been actively pursued as promising targeted therapeutics. Here, we assess the key structural and physicochemical properties, target selectivity and mechanism of function...

FDA's Activities Supporting Regulatory Application of "Next Gen" Sequencing Technologies.

Science.gov (United States)

Wilson, Carolyn A; Simonyan, Vahan

2014-01-01

Applications of next-generation sequencing (NGS) technologies require availability and access to an information technology (IT) infrastructure and bioinformatics tools for large amounts of data storage and analyses. The U.S. Food and Drug Administration (FDA) anticipates that the use of NGS data to support regulatory submissions will continue to increase as the scientific and clinical communities become more familiar with the technologies and identify more ways to apply these advanced methods to support development and evaluation of new biomedical products. FDA laboratories are conducting research on different NGS platforms and developing the IT infrastructure and bioinformatics tools needed to enable regulatory evaluation of the technologies and the data sponsors will submit. A High-performance Integrated Virtual Environment, or HIVE, has been launched, and development and refinement continues as a collaborative effort between the FDA and George Washington University to provide the tools to support these needs. The use of a highly parallelized environment facilitated by use of distributed cloud storage and computation has resulted in a platform that is both rapid and responsive to changing scientific needs. The FDA plans to further develop in-house capacity in this area, while also supporting engagement by the external community, by sponsoring an open, public workshop to discuss NGS technologies and data formats standardization, and to promote the adoption of interoperability protocols in September 2014. Next-generation sequencing (NGS) technologies are enabling breakthroughs in how the biomedical community is developing and evaluating medical products. One example is the potential application of this method to the detection and identification of microbial contaminants in biologic products. In order for the U.S. Food and Drug Administration (FDA) to be able to evaluate the utility of this technology, we need to have the information technology infrastructure and

Evidence behind FDA alerts for drugs with adverse cardiovascular effects: implications for clinical practice.

Science.gov (United States)

Rackham, Daniel M; C Herink, Megan; Stevens, Ian G; Cardoza, Natalie M; Singh, Harleen

2014-01-01

The U.S. Food and Drug Administration (FDA) periodically publishes Drug Safety Communications and Drug Alerts notifying health care practitioners and the general public of important information regarding drug therapies following FDA approval. These alerts can result in both positive and negative effects on patient care. Most clinical trials are not designed to detect long-term safety end points, and postmarketing surveillance along with patient reported events are often instrumental in signaling the potential harmful effect of a drug. Recently, many cardiovascular (CV) safety announcements have been released for FDA-approved drugs. Because a premature warning could discourage a much needed treatment or prompt a sudden discontinuation, it is essential to evaluate the evidence supporting these FDA alerts to provide effective patient care and to avoid unwarranted changes in therapy. Conversely, paying attention to these warnings in cases involving high-risk patients can prevent adverse effects and litigation. This article reviews the evidence behind recent FDA alerts for drugs with adverse CV effects and discusses the clinical practice implications. © 2013 Pharmacotherapy Publications, Inc.

High performance ZIF-8/6FDA-DAM mixed matrix membrane for propylene/propane separations

KAUST Repository

Zhang, Chen; Dai, Ying; Johnson, Justin R.; Karvan, Oguz; Koros, William J.

2012-01-01

We report significantly enhanced propylene/propane (C 3H 6/C 3H 8) selectivity in mixed matrix membranes fabricated using 6FDA-DAM polyimide and a zeolitic imidazolate framework (ZIF-8). Equilibrium isotherms and sorption kinetics of C 3H 6 and C 3H 8 at 35°C were studied on a 200nm commercially available ZIF-8 sample produced by BASF. Mixed matrix dense films were formed with 6FDA-DAM and 200nm BASF ZIF-8 particles. SEM imaging showed generally good adhesion between the ZIF-8 and 6FDA-DAM without the need for surface-treating ZIF-8. Pure gas permeation showed significantly enhanced mixed matrix ZIF-8/6FDA-DAM membrane C 3H 6/C 3H 8 separation performance over the pure 6FDA-DAM membrane performance. A C 3H 6 permeability of 56.2Barrer and C 3H 6/C 3H 8 ideal selectivity of 31.0 was found in ZIF-8/6FDA-DAM mixed matrix membrane with 48.0wt% ZIF-8 loading, which are 258% and 150% higher than the pure 6FDA-DAM membrane, respectively for permeability and selectivity. Permeation properties of C 3H 6 and C 3H 8 in ZIF-8 were back-calculated by the Maxwell model for composite permeability using pure gas permeation data, leading to a C 3H 6 permeability of 277Barrer and C 3H 6/C 3H 8 selectivity of 122. Mixed gas permeation also verified that selectivity enhancements were achievable in mixed gas environment by ZIF-8. © 2011 Elsevier B.V.

High performance ZIF-8/6FDA-DAM mixed matrix membrane for propylene/propane separations

KAUST Repository

Zhang, Chen

2012-02-01

We report significantly enhanced propylene/propane (C 3H 6/C 3H 8) selectivity in mixed matrix membranes fabricated using 6FDA-DAM polyimide and a zeolitic imidazolate framework (ZIF-8). Equilibrium isotherms and sorption kinetics of C 3H 6 and C 3H 8 at 35°C were studied on a 200nm commercially available ZIF-8 sample produced by BASF. Mixed matrix dense films were formed with 6FDA-DAM and 200nm BASF ZIF-8 particles. SEM imaging showed generally good adhesion between the ZIF-8 and 6FDA-DAM without the need for surface-treating ZIF-8. Pure gas permeation showed significantly enhanced mixed matrix ZIF-8/6FDA-DAM membrane C 3H 6/C 3H 8 separation performance over the pure 6FDA-DAM membrane performance. A C 3H 6 permeability of 56.2Barrer and C 3H 6/C 3H 8 ideal selectivity of 31.0 was found in ZIF-8/6FDA-DAM mixed matrix membrane with 48.0wt% ZIF-8 loading, which are 258% and 150% higher than the pure 6FDA-DAM membrane, respectively for permeability and selectivity. Permeation properties of C 3H 6 and C 3H 8 in ZIF-8 were back-calculated by the Maxwell model for composite permeability using pure gas permeation data, leading to a C 3H 6 permeability of 277Barrer and C 3H 6/C 3H 8 selectivity of 122. Mixed gas permeation also verified that selectivity enhancements were achievable in mixed gas environment by ZIF-8. © 2011 Elsevier B.V.

Estimating capacity of solar thermoelectric generator (STEG) panels

International Nuclear Information System (INIS)

Kokhova, I.I.; Malevskii, Yu.N.; Tsvetkov, A.I.

1979-01-01

Energy characteristics of a solar thermoelectric generator (STEG) panel without solar-flux concentration are considered. The design of such devices is no simple task. Several fully justified assumptions have been introduced in an attempt to obtain a solution convenient for engineering calculations

21 CFR 801.128 - Exceptions or alternatives to labeling requirements for medical devices held by the Strategic...

Science.gov (United States)

2010-04-01

... requirements for medical devices held by the Strategic National Stockpile. 801.128 Section 801.128 Food and... requirements for medical devices held by the Strategic National Stockpile. (a) The appropriate FDA Center... Strategic National Stockpile. (b)(1)(i) A Strategic National Stockpile official or any entity that...

Safety and effectiveness considerations for clinical studies of visual prosthetic devices

Science.gov (United States)

Cohen, Ethan D.

2007-03-01

With the advent of new designs of visual prostheses for the blind, FDA is faced with developing guidance for evaluating their engineering, safety and patient performance. Visual prostheses are considered significant risk medical devices, and their use in human clinical trials must be approved by FDA under an investigation device exemption (IDE). This paper contains a series of test topics and design issues that sponsors should consider in order to assess the safety and efficacy of their device. The IDE application includes a series of pre-clinical and clinical data sections. The pre-clinical section documents laboratory, animal and bench top performance tests of visual prostheses safety and reliability to support a human clinical trial. The materials used in constructing the implant should be biocompatible, sterile, corrosion resistant, and able to withstand any forces exerted on it during normal patient use. The clinical data section is composed of items related to patient-related evaluation of device performance. This section documents the implantation procedure, trial design, statistical analysis and how visual performance is assessed. Similar to cochlear implants, a visual prosthesis is expected to last in the body for many years, and good pre-clinical and clinical testing will help ensure its safety, durability and effectiveness.

Dose Matters: FDA's Guidance on Children's X-rays

Science.gov (United States)

... Consumer Updates Dose Matters: FDA's Guidance on Children's X-rays Share Tweet Linkedin Pin it More sharing options ... exposure during medical procedures. The level of ionizing radiation from X-ray imaging is generally very low, but can ...

Pressurized waterproof case for electronic device

KAUST Repository

Berumen, Michael L.

2013-01-01

having an open top panel or face covered by a flexible, transparent membrane or the like for the operation of the touch-screen device within the case. A pressurizing system is provided for the case to pressurize the case and the electronic device therein

NPC Based Design Optimization for a Net Zero Office Building in Hot Climates with PV Panels as Shading Device

Directory of Open Access Journals (Sweden)

Muhammad Zubair

2018-05-01

Full Text Available Hot areas of the world receive a high amount of solar radiation. As a result, buildings in those areas consume more energy to maintain a comfortable climate for their inhabitants. In an effort to design net-zero energy building in hot climates, PV possesses the unique advantage of generating electrical energy while protecting the building from solar irradiance. In this work, to form a net-zero energy building (NZEB, renewable resources such as solar and wind available onsite for an existing building have been analyzed in a hot climate location. PV and wind turbines in various configurations are studied to form a NZEB, where PV-only systems offer better performance than Hybrid PV Wind systems, based on net present cost (NPC. The self-shading losses in PV placed on rooftop areas are analyzed by placing parallel arrays of PV modules at various distances in between them. The effect on building cooling load by rooftop PV panels as shading devices is investigated. Furthermore, self-shading losses of PV are compared by the savings in cooling loads using PV as shading. In the case study, 12.3% saving in the cooling load of the building is observed when the building rooftop is completed shaded by PV panels; annual cooling load decreased from 3.417 GWh to 2.996 GWh, while only 1.04% shaded losses are observed for fully shaded (FS buildings compared to those with no shading (NS, as PV generation decreases from 594.39 kWh/m2 to 588.21 kWh/m2. The net present cost of the project has been decreased from US$4.77 million to US$4.41 million by simply covering the rooftop completely with PV panels, for a net-zero energy building.

Single Cigarette Sales: State Differences in FDA Advertising and Labeling Violations, 2014, United States.

Science.gov (United States)

Baker, Hannah M; Lee, Joseph G L; Ranney, Leah M; Goldstein, Adam O

2016-02-01

Single cigarettes, which are sold without warning labels and often evade taxes, can serve as a gateway for youth smoking. The Family Smoking Prevention and Tobacco Control Act of 2009 gives the US Food and Drug Administration (FDA) authority to regulate the manufacture, distribution, and marketing of tobacco products, including prohibiting the sale of single cigarettes. To enforce these regulations, the FDA conducted over 335,661 inspections between 2010 and September 30, 2014, and allocated over $115 million toward state inspections contracts. To examine differences in single cigarette violations across states and determine if likely correlates of single cigarette sales predict single cigarette violations at the state level. Cross-sectional study of publicly available FDA warning letters from January 1 to July 31, 2014. All 50 states and the District of Columbia. Tobacco retailer inspections conducted by FDA (n = 33 543). State cigarette tax, youth smoking prevalence, poverty, and tobacco production. State proportion of FDA warning letters issued for single cigarette violations. There are striking differences in the number of single cigarette violations found by state, with 38 states producing no warning letters for selling single cigarettes even as state policymakers developed legislation to address retailer sales of single cigarettes. The state proportion of warning letters issued for single cigarettes is not predicted by state cigarette tax, youth smoking, poverty, or tobacco production, P = .12. Substantial, unexplained variation exists in violations of single cigarette sales among states. These data suggest the possibility of differences in implementation of FDA inspections and the need for stronger quality monitoring processes across states implementing FDA inspections. © The Author 2015. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Steam/water separation device for drying a wet vapour

International Nuclear Information System (INIS)

Sundheimer, P.

1986-01-01

The aim of the present invention is to dry a wet vapour which flows up to the device. The device has at least a group of steam dryer elements in a zone in which there is a vertical apertured panel; this vertical apertured panel is a metal grille with baffles the inlet steam flow to make it horizontal or slightly inclined to the bottom. The invention applies more particularly, to PWR steam generators [fr

78 FR 2647 - Dental Devices; Reclassification of Blade-Form Endosseous Dental Implant

Science.gov (United States)

2013-01-14

.... FDA-2012-N-0677] Dental Devices; Reclassification of Blade-Form Endosseous Dental Implant AGENCY: Food...) is proposing to reclassify the blade- form endosseous dental implant, a preamendments class III... proposing to revise the classification of blade-form endosseous dental implants. DATES: Submit either...

Agreements and Discrepancies between FDA Reports and Journal Papers on Biologic Agents Approved for Rheumatoid Arthritis

DEFF Research Database (Denmark)

Amarilyo, Gil; Furst, Daniel E; Woo, Jennifer M P

2016-01-01

BACKGROUND: Sponsors that seek to commercialize new drugs apply to the Food and Drug Administration (FDA) which independently analyzes the raw data and reports the results on its website. OBJECTIVES: This study sought to determine if there are differences between the FDA assessments and journal...... reports on biologic agents developed for the treatment of rheumatoid arthritis. METHODS: Available data on FDA-approved drugs were extracted from the website, and a systematic literature search was conducted to identify matching studies in peer-reviewed medical journals. Outcome measures were the American...... College of Rheumatology response criteria ACR20 (efficacy) and withdrawal due to adverse events (safety). As effect size odds ratios were estimated for each active trial arm vs. control arm (i.e. for both sources: FDA and journal report), followed by calculation of the ratios of the FDA and journal report...

Control system of fuel transporting device

International Nuclear Information System (INIS)

Yokota, Minoru.

1981-01-01

Purpose: To effectively avoid an obstacle in a fuel transporting device by reading the outputs of absolute position detectors mounted on movable trucks, controlling the movements of the trucks, and thereby smoothly and accurately positioning the fuel transporting device at predetermined position and providing a contact detector thereat. Method: The outputs from absolute position detectors which are mounted on a longitudinally movable truck and a laterally movable truck are input to an input/output control circuit. The input/output control circuit serves to compare, the position a fuel transporting device is to be moved to, with the present position on the basis of said input detection signal and a command signal from an operator console, to calculate the amount of movement to be driven, to produce an operation signal therefor to a control panel, and to drive and control the drive motors which are respectively mounted on the trucks for the fuel transfer device. On the other hand, in case that the transfer device comes into contact with an obstacle, the contact detector will immediately operate to produce a stop command through the control panel to the transporting device, and avoid a collision with the obstacle. (Yoshino, Y.)

Quality assessment of digital annotated ECG data from clinical trials by the FDA ECG Warehouse.

Science.gov (United States)

Sarapa, Nenad

2007-09-01

The FDA mandates that digital electrocardiograms (ECGs) from 'thorough' QTc trials be submitted into the ECG Warehouse in Health Level 7 extended markup language format with annotated onset and offset points of waveforms. The FDA did not disclose the exact Warehouse metrics and minimal acceptable quality standards. The author describes the Warehouse scoring algorithms and metrics used by FDA, points out ways to improve FDA review and suggests Warehouse benefits for pharmaceutical sponsors. The Warehouse ranks individual ECGs according to their score for each quality metric and produces histogram distributions with Warehouse-specific thresholds that identify ECGs of questionable quality. Automatic Warehouse algorithms assess the quality of QT annotation and duration of manual QT measurement by the central ECG laboratory.

Investigation on a short circuit of large-area OLED lighting panels

International Nuclear Information System (INIS)

Park, J W; Kim, T W; Park, J B

2013-01-01

A short circuit often arises from large-area organic light-emitting device (OLED) lighting panels due to particles (i.e. dust, organic or metal debris) or the spike-like surface of the indium–tin–oxide (ITO) anode. On the emergence of a short circuit, an instant current crowding occurs, thereby reducing substantially the resistance of the panels and causing a failure of a dimming control. In this paper, we investigate the effect of the surface morphology of ITO on the resistance and dimmability of the panels. We have demonstrated that the peak-to-valley roughness of ITO should be much less than 20 nm or the resistance of the panels should be much higher than 1 MΩ in order to avoid an unwanted short-circuit phenomenon and thus achieve the high-yield fabrication of OLED lighting panels. It is also addressed that much care is taken to ensure a dimming control of OLED lighting panels with a larger active area because the resistance of those panels varies depending more sensitively on the surface roughness of ITO. (paper)

Characterizing the reflectivity of handheld display devices.

Science.gov (United States)

Liu, Peter; Badano, Aldo

2014-08-01

With increased use of handheld and tablet display devices for viewing medical images, methods for consistently measuring reflectivity of the devices are needed. In this note, the authors report on the characterization of diffuse reflections for handheld display devices including mobile phones and tablets using methods recommended by the American Association of Physicists in Medicine Task Group 18 (TG18). The authors modified the diffuse reflectance coefficient measurement method outlined in the TG18 report. The authors measured seven handheld display devices (two phones and five tablets) and three workstation displays. The device was attached to a black panel with Velcro. To study the effect of the back surface on the diffuse reflectance coefficient, the authors created Styrofoam masks with different size square openings and placed it in front of the device. Overall, for each display device, measurements of illuminance and reflected luminance on the display screen were taken. The authors measured with no mask, with masks of varying size, and with display-size masks, and calculated the corresponding diffuse reflectance coefficient. For all handhelds, the diffuse reflectance coefficient measured with no back panel were lower than measurements performed with a mask. The authors found an overall increase in reflectivity as the size of the mask decreases. For workstations displays, diffuse reflectance coefficients were higher when no back panel was used, and higher than with masks. In all cases, as luminance increased, illuminance increased, but not at the same rate. Since the size of handheld displays is smaller than that of workstation devices, the TG18 method suffers from a dependency on illumination condition. The authors show that the diffuse reflection coefficients can vary depending on the nature of the back surface of the illuminating box. The variability in the diffuse coefficient can be as large as 20% depending on the size of the mask. For all measurements

78 FR 79308 - Dental Devices; Reclassification of Temporary Mandibular Condyle Prosthesis

Science.gov (United States)

2013-12-30

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 872 [Docket No. FDA-2012-N-1239] Dental Devices; Reclassification of Temporary Mandibular Condyle Prosthesis AGENCY... delegated to the Commissioner of Food and Drugs, 21 CFR part 872 is amended as follows: PART 872--DENTAL...

Could FDA approval of pre-exposure prophylaxis make a difference? A qualitative study of PrEP acceptability and FDA perceptions among men who have sex with men

OpenAIRE

Underhill, Kristen; Morrow, Kathleen M.; Operario, Don; Mayer, Kenneth H.

2014-01-01

The FDA has approved tenofovir-emtricitabine for use as HIV pre-exposure prophylaxis, but it is unknown how approval may affect PrEP acceptability among US men who have sex with men. We conducted 8 focus groups among 38 Rhode Island MSM, including 3 groups among 16 male sex workers and 5 groups among 22 men in the general MSM community. Participants reported wide-ranging beliefs regarding consequences and meanings of FDA approval. Some participants would not use PrEP without approval, while o...

76 FR 36548 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Science.gov (United States)

2011-06-22

... information related to the humanitarian device exemption for the Berlin Heart EXCOR Pediatric Ventricular Assist Device (VAD) sponsored by Berlin Heart, Inc. The Berlin Heart EXCOR Pediatric VAD device is a..., please contact AnnMarie Williams, Conference Management Staff, at 301-796-5966, at least 7 days in...

Customizable orthopaedic oncology implants: one institution's experience with meeting current IRB and FDA requirements.

Science.gov (United States)

Willis, Alexander R; Ippolito, Joseph A; Patterson, Francis R; Benevenia, Joseph; Beebe, Kathleen S

2016-01-01

Customizable orthopaedic implants are often needed for patients with primary malignant bone tumors due to unique anatomy or complex mechanical problems. Currently, obtaining customizable orthopaedic implants for orthopaedic oncology patients can be an arduous task involving submitting approval requests to the Institutional Review Board (IRB) and the Food and Drug Administration (FDA). There is great potential for the delay of a patient's surgery and unnecessary paperwork if the submission pathways are misunderstood or a streamlined protocol is not in place. The objective of this study was to review the existing FDA custom implant approval pathways and to determine whether this process was improved with an institutional protocol. An institutional protocol for obtaining IRB and FDA approval for customizable orthopaedic implants was established with the IRB at our institution in 2013. This protocol was approved by the IRB, such that new patients only require submission of a modification to the existing protocol with individualized patient information. During the two-year period of 2013-2014, eight patients were retrospectively identified as having required customizable implants for various orthopaedic oncology surgeries. The dates of request for IRB approval, request for FDA approval, and total time to surgery were recorded, along with the specific pathway utilized for FDA approval. The average patient age was 12 years old (7-21 years old). The average time to IRB approval of a modification to the pre-approved protocol was 14 days (7-21 days). Average time to FDA approval after submission of the IRB approval to the manufacturer was 12.5 days (7-19 days). FDA approval was obtained for all implants as compassionate use requests in accordance with Section 561 of the Federal Food Drug and Cosmetic Act's expanded access provisions. Establishment of an institutional protocol with pre-approval by the IRB can expedite the otherwise time-consuming and complicated

Medical Device Recalls in Radiation Oncology: Analysis of US Food and Drug Administration Data, 2002-2015.

Science.gov (United States)

Connor, Michael J; Tringale, Kathryn; Moiseenko, Vitali; Marshall, Deborah C; Moore, Kevin; Cervino, Laura; Atwood, Todd; Brown, Derek; Mundt, Arno J; Pawlicki, Todd; Recht, Abram; Hattangadi-Gluth, Jona A

2017-06-01

To analyze all recalls involving radiation oncology devices (RODs) from the US Food and Drug Administration (FDA)'s recall database, comparing these with non-radiation oncology device recalls to identify discipline-specific trends that may inform improvements in device safety. Recall data on RODs from 2002 to 2015 were sorted into 4 product categories (external beam, brachytherapy, planning systems, and simulation systems). Outcomes included determined cause of recall, recall class (severity), quantity in commerce, time until recall termination (date FDA determines recall is complete), and time since 510(k) approval. Descriptive statistics were performed with linear regression of time-series data. Results for RODs were compared with those for other devices by Pearson χ 2 test for categorical data and 2-sample Kolmogorov-Smirnov test for distributions. There were 502 ROD recalls and 9534 other class II device recalls during 2002 to 2015. Most recalls were for external beam devices (66.7%) and planning systems (22.9%), and recall events peaked in 2011. Radiation oncology devices differed significantly from other devices in all recall outcomes (P≤.04). Recall cause was commonly software related (49% vs 10% for other devices). Recall severity was more often moderate among RODs (97.6% vs 87.2%) instead of severe (0.2% vs 4.4%; Panalysis of recall data can identify areas for device improvement, such as better system design among RODs. Copyright © 2017 Elsevier Inc. All rights reserved.

Changes in the utilization of osteoporosis drugs after the 2010 FDA bisphosphonate drug safety communication

Directory of Open Access Journals (Sweden)

Bander Balkhi

2018-02-01

Conclusions: The 2010 FDA bisphosphonates safety communication appeared to have influenced Osteoporosis utilization in Medicaid recipients. The 2010 FDA bisphosphonates safety communication was associated with a significant reduction in the utilization of bisphosphonates in the Medicaid program.

Panels Manufactured from Vegetable Fibers: An Alternative Approach for Controlling Noises in Indoor Environments

Directory of Open Access Journals (Sweden)

Leopoldo Pacheco Bastos

2012-01-01

Full Text Available Noise control devices such as panels and barriers, when of high efficiency, generally are of difficult acquisition due to high costs turning in many cases their use impracticable, mainly for limited budget small-sized companies. There is a huge requirement for new acoustic materials that have satisfactory performance, not only under acoustic aspect but also other relevant ones and are of low cost. Vegetable fibers are an alternative solution when used as panels since they promise satisfactory acoustic absorption, according to previous researches, exist in abundance, and derive from renewable sources. This paper, therefore, reports on the development of panels made from vegetable fibers (coconut, palm, sisal, and açaí, assesses their applicability by various experimental (flammability, odor, fungal growth, and ageing tests, and characterize them acoustically in terms of their sound absorption coefficients on a scale model reverberant chamber. Acoustic results point out that the aforementioned fiber panels play pretty well the role of a noise control device since they have compatible, and in some cases, higher performance when compared to commercially available conventional materials.

Design control considerations for biologic-device combination products.

Science.gov (United States)

Anderson, Dave; Liu, Roger; Anand Subramony, J; Cammack, Jon

2017-03-01

Combination products are therapeutic and diagnostic medical products that combine drugs, devices, and/or biological products with one another. Historically, biologics development involved identifying efficacious doses administered to patients intravenously or perhaps by a syringe. Until fairly recently, there has been limited focus on developing an accompanying medical device, such as a prefilled syringe or auto-injector, to enable easy and more efficient delivery. For the last several years, and looking forward, where there may be little to distinguish biologics medicines with relatively similar efficacy profiles, the biotechnology market is beginning to differentiate products by patient-focused, biologic-device based combination products. As innovative as biologic-device combination products are, they can pose considerable development, regulatory, and commercialization challenges due to unique physicochemical properties and special clinical considerations (e.g., dosing volumes, frequency, co-medications, etc.) of the biologic medicine. A biologic-device combination product is a marriage between two partners with "cultural differences," so to speak. There are clear differences in the development, review, and commercialization processes of the biologic and the device. When these two cultures come together in a combination product, developers and reviewers must find ways to address the design controls and risk management processes of both the biologic and device, and knit them into a single entity with supporting product approval documentation. Moreover, digital medicine and connected health trends are pushing the boundaries of combination product development and regulations even further. Despite an admirable cooperation between industry and FDA in recent years, unique product configurations and design features have resulted in review challenges. These challenges have prompted agency reviewers to modernize consultation processes, while at the same time, promoting

Use of endpoint adjudication to improve the quality and validity of endpoint assessment for medical device development and post marketing evaluation: Rationale and best practices. A report from the cardiac safety research consortium.

Science.gov (United States)

Seltzer, Jonathan H; Heise, Ted; Carson, Peter; Canos, Daniel; Hiatt, Jo Carol; Vranckx, Pascal; Christen, Thomas; Cutlip, Donald E

2017-08-01

This white paper provides a summary of presentations, discussions and conclusions of a Thinktank entitled "The Role of Endpoint Adjudication in Medical Device Clinical Trials". The think tank was cosponsored by the Cardiac Safety Research Committee, MDEpiNet and the US Food and Drug Administration (FDA) and was convened at the FDA's White Oak headquarters on March 11, 2016. Attention was focused on tailoring best practices for evaluation of endpoints in medical device clinical trials, practical issues in endpoint adjudication of therapeutic, diagnostic, biomarker and drug-device combinations, and the role of adjudication in regulatory and reimbursement issues throughout the device lifecycle. Attendees included representatives from medical device companies, the FDA, Centers for Medicare and Medicaid Services (CMS), end point adjudication specialist groups, clinical research organizations, and active, academically based adjudicators. The manuscript presents recommendations from the think tank regarding (1) rationale for when adjudication is appropriate, (2) best practices establishment and operation of a medical device adjudication committee and (3) the role of endpoint adjudication for post market evaluation in the emerging era of real world evidence. Copyright © 2017. Published by Elsevier Inc.

Devices and Endoscopic Bariatric Therapies for Obesity.

Science.gov (United States)

Saunders, Katherine H; Igel, Leon I; Saumoy, Monica; Sharaiha, Reem Z; Aronne, Louis J

2018-04-17

In this review, we describe the FDA-approved and investigational devices and endoscopic bariatric therapies for the treatment of obesity. We focus on literature published in the past few years and present mechanisms of action as well as efficacy and safety data. Devices and endoscopic procedures are emerging options to fill the significant treatment gap in the management of obesity. Not only are these devices and procedures minimally invasive and reversible, but they are potentially more effective than antiobesity medications, often safer for poor surgical candidates and possibly less expensive than bariatric surgery. As many patients require a variety of management strategies (medications, devices, procedures, and/or surgery) in addition to lifestyle modifications to achieve clinically significant weight loss, the future of obesity treatment involves a multidisciplinary approach. Combinations of advanced treatment strategies can lead to additive or synergistic weight loss. This is an area that requires further investigation.

Simulating cosmic radiation absorption and secondary particle production of solar panel layers of Low Earth Orbit (LEO) satellite with GEANT4

Science.gov (United States)

Yiǧitoǧlu, Merve; Veske, Doǧa; Nilüfer Öztürk, Zeynep; Bilge Demirköz, Melahat

2016-07-01

All devices which operate in space are exposed to cosmic rays during their operation. The resulting radiation may cause fatal damages in the solid structure of devices and the amount of absorbed radiation dose and secondary particle production for each component should be calculated carefully before the production. Solar panels are semiconductor solid state devices and are very sensitive to radiation. Even a short term power cut-off may yield a total failure of the satellite. Even little doses of radiation can change the characteristics of solar cells. This deviation can be caused by rarer high energetic particles as well as the total ionizing dose from the abundant low energy particles. In this study, solar panels planned for a specific LEO satellite, IMECE, are analyzed layer by layer. The Space Environment Information System (SPENVIS) database and GEANT4 simulation software are used to simulate the layers of the panels. The results obtained from the simulation will be taken in account to determine the amount of radiation protection and resistance needed for the panels or to revise the design of the panels.

Price, performance, and the FDA approval process: the example of home HIV testing.

Science.gov (United States)

Paltiel, A David; Pollack, Harold A

2010-01-01

The Food and Drug Administration (FDA) is considering approval of an over-the-counter, rapid HIV test for home use. To support its decision, the FDA seeks evidence of the test's performance. It has asked the manufacturer to conduct field studies of the test's sensitivity and specificity when employed by untrained users. In this article, the authors argue that additional information should be sought to evaluate the prevalence of undetected HIV in the end-user The analytic framework produces the elementary but counterintuitive finding that the performance of the home HIV test- measured in terms of its ability to correctly detect the presence and absence of HIV infection among the people who purchase it-depends critically on the manufacturer's retail price. This finding has profound implications for the FDA's approval process.

Semiconductor-based, large-area, flexible, electronic devices on {110} oriented substrates

Science.gov (United States)

Goyal, Amit

2014-08-05

Novel articles and methods to fabricate the same resulting in flexible, oriented, semiconductor-based, electronic devices on {110} textured substrates are disclosed. Potential applications of resulting articles are in areas of photovoltaic devices, flat-panel displays, thermophotovoltaic devices, ferroelectric devices, light emitting diode devices, computer hard disc drive devices, magnetoresistance based devices, photoluminescence based devices, non-volatile memory devices, dielectric devices, thermoelectric devices and quantum dot laser devices.

[100] or [110] aligned, semiconductor-based, large-area, flexible, electronic devices

Science.gov (United States)

Goyal, Amit

2015-03-24

Novel articles and methods to fabricate the same resulting in flexible, large-area, [100] or [110] textured, semiconductor-based, electronic devices are disclosed. Potential applications of resulting articles are in areas of photovoltaic devices, flat-panel displays, thermophotovoltaic devices, ferroelectric devices, light emitting diode devices, computer hard disc drive devices, magnetoresistance based devices, photoluminescence based devices, non-volatile memory devices, dielectric devices, thermoelectric devices and quantum dot laser devices.

First clinical experience with Celt ACD(®) : a femoral arterial puncture closure device.

LENUS (Irish Health Repository)

Jan, Aftab

2013-08-01

This prospective nonrandomized study compared the safety and efficacy of a novel arterial closure device (ACD) in common femoral artery procedures to that of the FDA submitted historical manual pressure control group, who underwent either a diagnostic angiogram (DA) or a percutaneous coronary intervention (PCI) procedure.

21 CFR 5.1110 - FDA public information offices.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false FDA public information offices. 5.1110 Section 5.1110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL...) Press Relations Staff. Press offices are located in White Oak Bldg. 1, 10903 New Hampshire Ave., Silver...

One and done: Reasons principal investigators conduct only one FDA-regulated drug trial

Directory of Open Access Journals (Sweden)

Amy Corneli, PhD, MPH

2017-06-01

Full Text Available Concerns have been raised over the high turnover rate for clinical investigators. Using the U.S. Food and Drug Administration's (FDA Bioresearch Monitoring Information System database, we conducted an online survey to identify factors that affect principal investigators' (PIs decisions to conduct only a single FDA-regulated drug trial. Of the 201 PIs who responded, 54.2% were classified as “one-and-done.” Among these investigators, 28.9% decided for personal reasons to not conduct another trial, and 44.4% were interested in conducting another trial, but no opportunities were available. Three categories of broad barriers were identified as generally burdensome or challenging by the majority of investigators: 1 workload balance (balancing trial implementation with other work obligations and opportunities (63.8%; 2 time requirements (time to initiate and implement trial; investigator and staff time (63.4%; and 3 data and safety reporting (56.5%. Additionally, 46.0% of investigators reported being generally unsatisfied with finance-related issues. These same top three barriers also affected investigators' decisions to no longer conduct FDA-regulated trials. Our findings illuminate three key aspects of investigator turnover. First, they confirm that investigator turnover occurs, as more than half of respondents were truly “one-and-done.” Second, because a large proportion of respondents wanted to conduct more FDA-regulated trials but lacked opportunities to do so, mechanisms that match interested investigators with research sponsors are needed. Third, by focusing on the barriers we identified that affected investigators' decisions to no longer conduct FDA-regulated trials, future efforts to reduce investigator turnover can target issues that matter the most to investigators.

DC current distribution mapping system of the solar panels using a HTS-SQUID gradiometer

International Nuclear Information System (INIS)

Miyazaki, Shingo; Kasuya, Syohei; Saari, Mohd Mawardi; Sakai, Kenji; Kiwa, Toshihiko; Tsukada, Keiji; Tsukamoto, Akira; Adachi, Seiji; Tanabe, Keiichi

2014-01-01

Solar panels are expected to play a major role as a source of sustainable energy. In order to evaluate solar panels, non-destructive tests, such as defect inspections and response property evaluations, are necessary. We developed a DC current distribution mapping system of the solar panels using a High Critical Temperature Superconductor Superconducting Quantum Interference Device (HTS-SQUID) gradiometer with ramp edge type Josephson junctions. Two independent components of the magnetic fields perpendicular to the panel surface (∂Bz/∂x, ∂Bz/∂y) were detected. The direct current of the solar panel is visualized by calculating the composition of the two signal components, the phase angle, and mapping the DC current vector. The developed system can evaluate the uniformity of DC current distributions precisely and may be applicable for defect detection of solar panels.

3D Printed Composites for Topology Transforming Multifunctional Devices

Science.gov (United States)

2017-01-26

panels connected by hinges, which occupy infinitesimal space but control the angles between two panels. Figure 2.2.1-3 shows panels are connected by...observations that higher curing temperature yields to more compacted and better connected silver NPs. The Young’s moduli, however, are lower than that of...AFRL-AFOSR-VA-TR-2017-0021 3D Printed Composites for Topology -Transforming Multifunctional Devices Kurt Maute REGENTS OF THE UNIVERSITY OF COLORADO

Cleaning Robot for Solar Panels in Solar Power Station

Science.gov (United States)

Hang, Lu-Bin; Shen, Cheng-Wei; Bian, Huai-Qiang; Wang, Yan

2016-05-01

The dust particles on solar panel surface have been a serious problem for the photovoltaic industry, a new monorail-tracked robot used for automatic cleaning of solar panel is presented in this paper. To meet the requirement of comprehensive and stable cleaning of PV array, the monorail-tracked pattern of robot is introduced based on the monorail structure technique. The running and striding mechanism are designed for mobility of robot on the solar panels. According to the carrying capacity and water circulation mechanism, a type of self-cleaning device with filtering system is developed. Combined with the computer software and communications technology, the control system is built in this robot, which can realize the functions of autonomous operation, positioning and monitoring. The application of this developed cleaning robot can actualize the Industrialization of automatic cleaning for PV components and have wide market prospect.

Barriers to clinical adoption of next generation sequencing: Perspectives of a policy Delphi panel

Directory of Open Access Journals (Sweden)

Donna A. Messner

2016-09-01

Full Text Available This research aims to inform policymakers by engaging expert stakeholders to identify, prioritize, and deliberate the most important and tractable policy barriers to the clinical adoption of next generation sequencing (NGS. A 4-round Delphi policy study was done with a multi-stakeholder panel of 48 experts. The first 2 rounds of online questionnaires (reported here assessed the importance and tractability of 28 potential barriers to clinical adoption of NGS across 3 major policy domains: intellectual property, coverage and reimbursement, and FDA regulation. We found that: 1 proprietary variant databases are seen as a key challenge, and a potentially intractable one; 2 payer policies were seen as a frequent barrier, especially a perceived inconsistency in standards for coverage; 3 relative to other challenges considered, FDA regulation was not strongly perceived as a barrier to clinical use of NGS. Overall the results indicate a perceived need for policies to promote data-sharing, and a desire for consistent payer coverage policies that maintain reasonably high standards of evidence for clinical utility, limit testing to that needed for clinical care decisions, and yet also flexibly allow for clinician discretion to use genomic testing in uncertain circumstances of high medical need.

78 FR 35284 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

Science.gov (United States)

2013-06-12

... summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2013-M-0036... Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY...

76 FR 31965 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

Science.gov (United States)

2011-06-02

... summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2011-M-0034... Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY...

Temperature Dependences on Various Types of Photovoltaic (PV) Panel

International Nuclear Information System (INIS)

Audwinto, I A; Leong, C S; Sopian, K; Zaidi, S H

2015-01-01

Temperature is one of the key roles in PV technology performance, since with the increases of temperature the open-circuit voltage will drop accordingly so do the electrical efficiency and power output generation. Different types of Photovoltaic (PV) panels- silicon solar panels and thin film solar panels; mono-crystalline, poly-crystalline, CIS, CIGS, CdTe, back-contact, and bi-facial solar panel under 40°C to 70°C approximately with 5°C interval have been comparatively analyzed their actual performances with uniformly distribution of light illumination from tungsten halogen light source, ±500W/m 2 . DC-Electronic Load and Data Logger devices with “Lab View” data program interface were used to collect all the necessary parameters in this study. Time needed to achieve a certain degree of temperature was recorded. Generally, each of the panels needed 15 minutes to 20 minutes to reach 70°C. Halogen based light source is not compatible in short wave-length in response to thin-film solar cell. Within this period of times, all the panels are facing a performance loss up to 15%. Other parameters; P max , V max , I max , V oc , I sc , R serries , R shunt , Fillfactor were collected as study cases. Our study is important in determining Photovoltaic type selection and system design as for study or industrial needed under different temperature condition. (paper)

We really need to talk: adapting FDA processes to rapid change.

Science.gov (United States)

Lykken, Sara

2013-01-01

The rapidly evolving realm of modern commerce strains traditional regulatory paradigms. This paper traces the historical evolution of FDA crisis-response regulation and provides examples of ways in which the definitions and procedures resulting from that past continue to be challenged by new products as market entrants, some in good faith and others not, take actions that create disconnects between actual product and marketing controls and those that consumers might expect. The paper then explores some of the techniques used by other federal agencies that have faced similar challenges in environments characterized by rapid innovation, and draws from this analysis suggestions for improvement of the FDA's warning letter system.

THPdb: Database of FDA-approved peptide and protein therapeutics.

Directory of Open Access Journals (Sweden)

Salman Sadullah Usmani

Full Text Available THPdb (http://crdd.osdd.net/raghava/thpdb/ is a manually curated repository of Food and Drug Administration (FDA approved therapeutic peptides and proteins. The information in THPdb has been compiled from 985 research publications, 70 patents and other resources like DrugBank. The current version of the database holds a total of 852 entries, providing comprehensive information on 239 US-FDA approved therapeutic peptides and proteins and their 380 drug variants. The information on each peptide and protein includes their sequences, chemical properties, composition, disease area, mode of activity, physical appearance, category or pharmacological class, pharmacodynamics, route of administration, toxicity, target of activity, etc. In addition, we have annotated the structure of most of the protein and peptides. A number of user-friendly tools have been integrated to facilitate easy browsing and data analysis. To assist scientific community, a web interface and mobile App have also been developed.

Portable low-cost flat panel detectors for real-time digital radiography

International Nuclear Information System (INIS)

Iovea, Mihai; Neagu, Marian; Stefanescu, Bogdan; Mateiasi, Gabriela; Porosnicu, Ioana; Angheluta, Elena

2015-01-01

The X-ray inspection is one of the most common used non-destructive testing methods in industry applications, but for the portable X-ray digital solution are not so many accessible, low-cost and versatile detection devices. The efficiency of a non-destructive X-ray portable device is represented by the quality of digital images, by its low acquisition time combined with a high resolution, in condition of low noise and at an affordable cost. The paper presents two X-ray portable imaging systems developed by us, suitable also for aerospace NDT applications, which are also very versatile for being easily adapted for other fields that requires mobile solutions. The first device described in the paper represent a portable large-size (210 mm X 550 mm) and high-resolution (27/54 microns) flat panel detector based on linear translation of a X-Ray TDI detector, destined for various components/parts real-time transmission measurements. The second system it is also a flat panel detectors, with a size of 510 mm X 610 mm, with the detector size from 0.2 mm until 1.5 mm, which can operate by applying the dual-energy method, very useful for discriminating materials by evaluating their Atomic effective number. The high resolution and low-cost of this flat-panels widens their applicability by covering large requirements, from identifying unwanted materials within a structure until detection of very thin cracks in complex components.

Portable low-cost flat panel detectors for real-time digital radiography

Energy Technology Data Exchange (ETDEWEB)

Iovea, Mihai; Neagu, Marian; Stefanescu, Bogdan; Mateiasi, Gabriela; Porosnicu, Ioana; Angheluta, Elena [Accent Pro 2000 S.R.L., Bucharest (Romania)

2015-07-01

The X-ray inspection is one of the most common used non-destructive testing methods in industry applications, but for the portable X-ray digital solution are not so many accessible, low-cost and versatile detection devices. The efficiency of a non-destructive X-ray portable device is represented by the quality of digital images, by its low acquisition time combined with a high resolution, in condition of low noise and at an affordable cost. The paper presents two X-ray portable imaging systems developed by us, suitable also for aerospace NDT applications, which are also very versatile for being easily adapted for other fields that requires mobile solutions. The first device described in the paper represent a portable large-size (210 mm X 550 mm) and high-resolution (27/54 microns) flat panel detector based on linear translation of a X-Ray TDI detector, destined for various components/parts real-time transmission measurements. The second system it is also a flat panel detectors, with a size of 510 mm X 610 mm, with the detector size from 0.2 mm until 1.5 mm, which can operate by applying the dual-energy method, very useful for discriminating materials by evaluating their Atomic effective number. The high resolution and low-cost of this flat-panels widens their applicability by covering large requirements, from identifying unwanted materials within a structure until detection of very thin cracks in complex components.

Consumer sleep tracking devices: a critical review.

Science.gov (United States)

Lee, Jeon; Finkelstein, Joseph

2015-01-01

Consumer sleep tracking devices are widely advertised as effective means to monitor and manage sleep quality and to provide positive effects on overall heath. However objective evidence supporting these claims is not always readily available. The goal of this study was to perform a comprehensive review of available information on six representative sleep tracking devices: BodyMedia FIT, Fitbit Flex, Jawbone UP, Basis Band, Innovative Sleep Solutions SleepTracker, and Zeo Sleep Manager Pro. The review was conducted along the following dimensions: output metrics, theoretical frameworks, systematic evaluation, and FDA clearance. The review identified a critical lack of basic information about the devices: five out of six devices provided no supporting information on their sensor accuracy and four out of six devices provided no information on their output metrics accuracy. Only three devices were found to have related peer-reviewed articles. However in these articles wake detection accuracy was revealed to be quite low and to vary widely (BodyMedia, 49.9±3.6%; Fitbit, 19.8%; Zeo, 78.9% to 83.5%). No supporting evidence on how well tracking devices can help mitigate sleep loss and manage sleep disturbances in practical life was provided.

Stress Testing of Organic Light- Emitting Diode Panels and Luminaires

Energy Technology Data Exchange (ETDEWEB)

Lynn Davis, Kelley Rountree, Karmann Mills

2018-01-31

This report builds on previous DOE efforts with OLED technology by updating information on a previously benchmarked OLED product (the Chalina luminaire from Acuity Brands) and provides new benchmarks on the performance of Brite 2 and Brite Amber OLED panels from OLEDWorks. During the tests described here, samples of these devices were subjected to continuous operation in stress tests at elevated ambient temperature environments of 35°C or 45°C. In addition, samples were also operated continuously at room temperature in a room temperature operational life test (RTOL). One goal of this study was to investigate whether these test conditions can accelerate failure of OLED panels, either through panel shorting or an open circuit in the panel. These stress tests are shown to provide meaningful acceleration of OLED failure modes, and an acceleration factor of 2.6 was calculated at 45°C for some test conditions. In addition, changes in the photometric properties of the emitted light (e.g., luminous flux and chromaticity maintenance) was also evaluated for insights into the long-term stability of these products compared to earlier generations. Because OLEDs are a lighting system, electrical testing was also performed on the panel-driver pairs to provide insights into the impact of the driver on long-term panel performance.

78 FR 14557 - Guidance for Industry and Food and Drug Administration Staff: Investigational Device Exemption...

Science.gov (United States)

2013-03-06

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0010] Guidance for Industry and Food and Drug Administration Staff: Investigational Device Exemption Guidance for Retinal Prostheses; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

The Use of PCs, Smartphones, and Tablets in a Probability-Based Panel Survey : Effects on Survey Measurement Error

NARCIS (Netherlands)

Lugtig, Peter; Toepoel, Vera

2016-01-01

Respondents in an Internet panel survey can often choose which device they use to complete questionnaires: a traditional PC, laptop, tablet computer, or a smartphone. Because all these devices have different screen sizes and modes of data entry, measurement errors may differ between devices. Using

77 FR 52742 - Public Meeting-Strengthening the National Medical Device Postmarket Surveillance System; Request...

Science.gov (United States)

2012-08-30

... Contact Person) no later than September 5, 2012. No commercial or promotional material will be permitted... develop and implement a comprehensive medical device postmarket surveillance strategy to collect, analyze... implementing this strategy, FDA is holding a public meeting to discuss the current and future state of medical...

76 FR 43691 - Unique Device Identification for Postmarket Surveillance and Enforcement; Public Workshop

Science.gov (United States)

2011-07-21

... limited and, therefore, FDA may limit the number of participants from each organization. If time and space... with device interoperability. 15. The current and future state of MMIS and RTLS systems to support safe.... Any lessons learned that can be applied from documenting medication use. 24. How the documentation of...

75 FR 51829 - Public Workshop on Medical Devices and Nanotechnology: Manufacturing, Characterization, and...

Science.gov (United States)

2010-08-23

... hotel at 301-977-8900 or refer to their Web page at: www.gaithersburg.hilton.com . Contact Person: Daya... provide public comments, time permitting. If you need special accommodations due to a disability, please... refer to the meeting registration Web page at http://www.fda.gov/MedicalDevices/NewsEvents/Workshops...

Usefulness of [18F]-DA and [18F]-DOPA for PET imaging in a mouse model of pheochromocytoma

International Nuclear Information System (INIS)

Martiniova, Lucia; Cleary, Susannah; Lai, Edwin W.; Kiesewetter, Dale O.; Seidel, Jurgen; Dawson, Linda F.; Phillips, Jacqueline K.; Thomasson, David; Chen Xiaoyuan; Eisenhofer, Graeme; Powers, James F.; Kvetnansky, Richard

2012-01-01

Purpose: To evaluate the usefulness of [ 18 F]-6-fluorodopamine ([ 18 F]-DA) and [ 18 F]-L-6-fluoro-3,4-dihydroxyphenylalanine ([ 18 F]-DOPA) positron emission tomography (PET) in the detection of subcutaneous (s.c.) and metastatic pheochromocytoma in mice; to assess the expression of the norepinephrine transporter (NET) and vesicular monoamine transporters 1 and 2 (VMAT1 and VMAT2), all important for [ 18 F]-DA and [ 18 F]-DOPA uptake. Furthermore, to compare tumor detection by micro-computed tomography (microCT) to magnetic resonance imaging (MRI) in individual mouse. Methods: SUV max values were calculated from [ 18 F]-DA and [ 18 F]-DOPA PET, tumor-to-liver ratios (TLR) were obtained and expression of NET, VMAT1 and VMAT2 was evaluated. Results: [ 18 F]-DA detected less metastatic lesions compared to [ 18 F]-DOPA. TLR values for liver metastases were 2.26–2.71 for [ 18 F]-DOPA and 1.83–2.83 for [ 18 F]-DA. A limited uptake of [ 18 F]-DA was found in s.c. tumors (TLR=0.22-0.27) compared to [ 18 F]-DOPA (TLR=1.56-2.24). Overall, NET and VMAT2 were expressed in all organ and s.c. tumors. However, s.c. tumors lacked expression of VMAT1. We confirmed [ 18 F]-DA's high affinity for the NET for its uptake and VMAT1 and VMAT2 for its storage and retention in pheochromocytoma cell vesicles. In contrast, [ 18 F]-DOPA was found to utilize only VMAT2. Conclusion: MRI was superior in the detection of all organ tumors compared to microCT and PET. [ 18 F]-DOPA had overall better sensitivity than [ 18 F]-DA for the detection of metastases. Subcutaneous tumors were localized only with [ 18 F]-DOPA, a finding that may reflect differences in expression of VMAT1 and VMAT2, perhaps similar to some patients with pheochromocytoma where [ 18 F]-DOPA provides better visualization of lesions than [ 18 F]-DA.

76 FR 45826 - Medical Device User Fee Rates for Fiscal Year 2012

Science.gov (United States)

2011-08-01

... paper check: All paper checks must be in U.S. currency from a U.S. bank and made payable to the Food and... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0542] Medical Device User Fee Rates for Fiscal Year 2012 AGENCY: Food and Drug Administration, HHS. ACTION...

Medical Device Recalls in Radiation Oncology: Analysis of US Food and Drug Administration Data, 2002-2015

International Nuclear Information System (INIS)

Connor, Michael J.; Tringale, Kathryn; Moiseenko, Vitali; Marshall, Deborah C.; Moore, Kevin; Cervino, Laura; Atwood, Todd; Brown, Derek; Mundt, Arno J.; Pawlicki, Todd; Recht, Abram; Hattangadi-Gluth, Jona A.

2017-01-01

Purpose: To analyze all recalls involving radiation oncology devices (RODs) from the US Food and Drug Administration (FDA)'s recall database, comparing these with non–radiation oncology device recalls to identify discipline-specific trends that may inform improvements in device safety. Methods and Materials: Recall data on RODs from 2002 to 2015 were sorted into 4 product categories (external beam, brachytherapy, planning systems, and simulation systems). Outcomes included determined cause of recall, recall class (severity), quantity in commerce, time until recall termination (date FDA determines recall is complete), and time since 510(k) approval. Descriptive statistics were performed with linear regression of time-series data. Results for RODs were compared with those for other devices by Pearson χ"2 test for categorical data and 2-sample Kolmogorov-Smirnov test for distributions. Results: There were 502 ROD recalls and 9534 other class II device recalls during 2002 to 2015. Most recalls were for external beam devices (66.7%) and planning systems (22.9%), and recall events peaked in 2011. Radiation oncology devices differed significantly from other devices in all recall outcomes (P≤.04). Recall cause was commonly software related (49% vs 10% for other devices). Recall severity was more often moderate among RODs (97.6% vs 87.2%) instead of severe (0.2% vs 4.4%; P<.001). Time from 510(k) market approval to recall was shorter among RODs (P<.001) and progressively shortened over time. Radiation oncology devices had fewer recalled devices in commerce than other devices (P<.001). Conclusions: Compared with other class II devices, RODs experience recalls sooner after market approval and are trending sooner still. Most of these recalls were moderate in severity, and software issues are prevalent. Comprehensive analysis of recall data can identify areas for device improvement, such as better system design among RODs.

Medical Device Recalls in Radiation Oncology: Analysis of US Food and Drug Administration Data, 2002-2015

Energy Technology Data Exchange (ETDEWEB)

Connor, Michael J. [Department of Radiation Medicine and Applied Sciences, University of California, San Diego, La Jolla, California (United States); University of California Irvine School of Medicine, Irvine, California (United States); Tringale, Kathryn; Moiseenko, Vitali; Marshall, Deborah C.; Moore, Kevin; Cervino, Laura; Atwood, Todd; Brown, Derek; Mundt, Arno J.; Pawlicki, Todd [Department of Radiation Medicine and Applied Sciences, University of California, San Diego, La Jolla, California (United States); Recht, Abram [Department of Radiation Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts (United States); Hattangadi-Gluth, Jona A., E-mail: jhattangadi@ucsd.edu [Department of Radiation Medicine and Applied Sciences, University of California, San Diego, La Jolla, California (United States)

2017-06-01

Purpose: To analyze all recalls involving radiation oncology devices (RODs) from the US Food and Drug Administration (FDA)'s recall database, comparing these with non–radiation oncology device recalls to identify discipline-specific trends that may inform improvements in device safety. Methods and Materials: Recall data on RODs from 2002 to 2015 were sorted into 4 product categories (external beam, brachytherapy, planning systems, and simulation systems). Outcomes included determined cause of recall, recall class (severity), quantity in commerce, time until recall termination (date FDA determines recall is complete), and time since 510(k) approval. Descriptive statistics were performed with linear regression of time-series data. Results for RODs were compared with those for other devices by Pearson χ{sup 2} test for categorical data and 2-sample Kolmogorov-Smirnov test for distributions. Results: There were 502 ROD recalls and 9534 other class II device recalls during 2002 to 2015. Most recalls were for external beam devices (66.7%) and planning systems (22.9%), and recall events peaked in 2011. Radiation oncology devices differed significantly from other devices in all recall outcomes (P≤.04). Recall cause was commonly software related (49% vs 10% for other devices). Recall severity was more often moderate among RODs (97.6% vs 87.2%) instead of severe (0.2% vs 4.4%; P<.001). Time from 510(k) market approval to recall was shorter among RODs (P<.001) and progressively shortened over time. Radiation oncology devices had fewer recalled devices in commerce than other devices (P<.001). Conclusions: Compared with other class II devices, RODs experience recalls sooner after market approval and are trending sooner still. Most of these recalls were moderate in severity, and software issues are prevalent. Comprehensive analysis of recall data can identify areas for device improvement, such as better system design among RODs.

Security and Privacy Qualities of Medical Devices: An Analysis of FDA Postmarket Surveillance

OpenAIRE

Ransford, Benjamin; Molina-Markham, Andres; Stewart, Quinn; Fu, Kevin; Kramer, Daniel Bruce; Baker, Matthew Charles; Reynolds, Matthew R.

2012-01-01

Background: Medical devices increasingly depend on computing functions such as wireless communication and Internet connectivity for software-based control of therapies and network-based transmission of patients’ stored medical information. These computing capabilities introduce security and privacy risks, yet little is known about the prevalence of such risks within the clinical setting. Methods: We used three comprehensive, publicly available databases maintained by the Food and Drug Admini...

75 FR 33169 - Dental Devices: Classification of Dental Amalgam, Reclassification of Dental Mercury, Designation...

Science.gov (United States)

2010-06-11

.... FDA-2008-N-0163] (formerly Docket No. 2001N-0067) RIN 0910-AG21 Dental Devices: Classification of Dental Amalgam, Reclassification of Dental Mercury, Designation of Special Controls for Dental Amalgam... the Federal Register of August 4, 2009 (74 FR 38686) which classified dental amalgam as a class II...

78 FR 49272 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Science.gov (United States)

2013-08-13

... into two types: (1) Devices that provide automatic chest compressions at a fixed compression rate and... circuit is comprised of multiple device types, including, but not limited to, an oxygenator, blood pump... submit a brief statement of the general nature of the evidence or arguments they wish to present, the...

Panel Analysis

DEFF Research Database (Denmark)

Brænder, Morten; Andersen, Lotte Bøgh

2014-01-01

Based on our 2013-article, ”Does Deployment to War Affect Soldiers' Public Service Motivation – A Panel Study of Soldiers Before and After their Service in Afghanistan”, we present Panel Analysis as a methodological discipline. Panels consist of multiple units of analysis, observed at two or more...... in research settings where it is not possible to distribute units of analysis randomly or where the independent variables cannot be manipulated. The greatest disadvantage in regard to using panel studies is that data may be difficult to obtain. This is most clearly vivid in regard to the use of panel surveys...... points in time. In comparison with traditional cross-sectional studies, the advantage of using panel studies is that the time dimension enables us to study effects. Whereas experimental designs may have a clear advantage in regard to causal inference, the strength of panel studies is difficult to match...

75 FR 5335 - Workshop on Pediatric Neurological and Neurocognitive Assessments for Cardiovascular Devices...

Science.gov (United States)

2010-02-02

..., 2010, from 8 a.m. to 5 p.m. Participants are encouraged to arrive early to ensure time for parking and... about lodging, and other relevant information will be posted, as it becomes available, on the Internet... on the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm...

Fisher, Neyman, and Bayes at FDA.

Science.gov (United States)

Rubin, Donald B

2016-01-01

The wise use of statistical ideas in practice essentially requires some Bayesian thinking, in contrast to the classical rigid frequentist dogma. This dogma too often has seemed to influence the applications of statistics, even at agencies like the FDA. Greg Campbell was one of the most important advocates there for more nuanced modes of thought, especially Bayesian statistics. Because two brilliant statisticians, Ronald Fisher and Jerzy Neyman, are often credited with instilling the traditional frequentist approach in current practice, I argue that both men were actually seeking very Bayesian answers, and neither would have endorsed the rigid application of their ideas.

{100} or 45.degree.-rotated {100}, semiconductor-based, large-area, flexible, electronic devices

Science.gov (United States)

Goyal, Amit [Knoxville, TN

2012-05-15

Novel articles and methods to fabricate the same resulting in flexible, {100} or 45.degree.-rotated {100} oriented, semiconductor-based, electronic devices are disclosed. Potential applications of resulting articles are in areas of photovoltaic devices, flat-panel displays, thermophotovoltaic devices, ferroelectric devices, light emitting diode devices, computer hard disc drive devices, magnetoresistance based devices, photoluminescence based devices, non-volatile memory devices, dielectric devices, thermoelectric devices and quantum dot laser devices.

Three Drugs Approved for Urothelial Carcinoma by FDA.

Science.gov (United States)

2017-07-01

The FDA has approved one PD-1 checkpoint inhibitor, pembrolizumab, and two PD-L1 checkpoint inhibitors, avelumab and durvalumab, to treat metastatic urothelial carcinoma in patients whose disease continues to progress despite platinum-based chemotherapy. This brings the total number of checkpoint inhibitors for the disease to five, prompting questions about how best to use them. ©2017 American Association for Cancer Research.

75 FR 59611 - Microbiology Devices; Reclassification of Herpes Simplex Virus Types 1 and 2 Serological Assays...

Science.gov (United States)

2010-09-28

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2009-N-0344] Microbiology Devices; Reclassification of Herpes Simplex Virus Types 1 and 2 Serological Assays; Confirmation of Effective Date AGENCY: Food and Drug Administration, HHS. ACTION: Direct...

78 FR 41069 - Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug...

Science.gov (United States)

2013-07-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0743] Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

78 FR 5185 - Guidance for Industry and Food and Drug Administration Staff; Humanitarian Use Device (HUD...

Science.gov (United States)

2013-01-24

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0847] Guidance for Industry and Food and Drug Administration Staff; Humanitarian Use Device (HUD) Designations... public comment ``Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use...

78 FR 69694 - Changing Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of Obesity...

Science.gov (United States)

2013-11-20

...] Changing Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of Obesity and... Administration (FDA) is announcing a public workshop entitled ``Changing Regulatory and Reimbursement Paradigms... information on the AGA Web site. If you need special accommodations due to a disability, please contact...

The Role of a Mental Model in Learning to Operate a Device.

Science.gov (United States)

Kieras, David E.; Bovair, Susan

1984-01-01

Describes three studies concerned with learning to operate a control panel device and how this learning is affected by understanding a device model that describes its internal mechanism. Results indicate benefits of a device model depend on whether it supports direct inference of exact steps required to operate the device. (Author/MBR)

Microcontroller-based system for analyzing and characterizing solar panels

International Nuclear Information System (INIS)

Jabbar, Muhandis Abdul; Prawito

2016-01-01

A solar cell is one of many alternative energy which is still being developed and it works by converting sunlight into electricity. In order to use a solar cell, a deep knowledge about the solar cell’s characteristics is needed. The current and voltage (I-V) produced when the light hits the solar cell surface with a certain value of intensity and at a certain value of temperature becomes the basic study to determine solar cell characteristics. In the past decade, there were so many developments of devices to characterize solar cells and solar panels. One of them used a MOSFET device for varying electronic load to observe solar cell current and voltage responses. However, many devices which have been developed even device on the market using many expensive tools and quite complex. Therefore in this research, a simple low cost electronic controlled device for solar cell characterization is built based on MOSFET method and a microcontroller but still has high reliability and accuracy.

Microcontroller-based system for analyzing and characterizing solar panels

Energy Technology Data Exchange (ETDEWEB)

Jabbar, Muhandis Abdul, E-mail: muhandis.abdul@sci.ui.ac.id; Prawito [System and Instrumentation, Departemen Fisika, FMIPA Universitas Indonesia, Kampus UI Depok (Indonesia)

2016-04-19

A solar cell is one of many alternative energy which is still being developed and it works by converting sunlight into electricity. In order to use a solar cell, a deep knowledge about the solar cell’s characteristics is needed. The current and voltage (I-V) produced when the light hits the solar cell surface with a certain value of intensity and at a certain value of temperature becomes the basic study to determine solar cell characteristics. In the past decade, there were so many developments of devices to characterize solar cells and solar panels. One of them used a MOSFET device for varying electronic load to observe solar cell current and voltage responses. However, many devices which have been developed even device on the market using many expensive tools and quite complex. Therefore in this research, a simple low cost electronic controlled device for solar cell characterization is built based on MOSFET method and a microcontroller but still has high reliability and accuracy.

FDA: polyurethane condom carries "extremely misleading" label. Federal agency allows distribution for public health's sake.

Science.gov (United States)

1995-02-01

The labeling of the Avanti polyurethane condom selling in 10 Western states makes misleading claims about protection from pregnancy and sexually transmitted diseases (STDs) according to officials at the US Food and Drug Administration (FDA). Avanti is sold in a foil package printed with the claim that it is effective against pregnancy, HIV, and STDs. However, polyurethane condoms have not undergone clinical efficacy testing for contraception or STDs, according to officials. The manufacturer of the condom refuted this allegation, stating that latex condoms have the same claims on them. In early 1995 the FDA met with the manufacturer and other companies developing plastic condoms, and concluded that these condoms could not make such claims, nor any claims about slippage and breakage rates. Despite warnings in 1993 to the manufacturer of Avanti about labeling restrictions, the company printed pregnancy and STD efficacy claims on the boxes and individual packages. The FDA later worked out a compromise with the firm in which only the boxes had to be reprinted with the generic label. The FDA had to weigh the risk of the public health cost of delaying sale of the condom, which is the first impermeable condom proven safe for people with latex allergies. In 1991 the FDA was defining standards for clinical testing and labeling of polyurethane condoms under congressional mandate, but the manufacturer of Avanti began mass production based on a preliminary approval determining that the condom was equivalent to latex condoms already on the market. 7000 Avanti condoms were subsequently tested in five countries, but these user tests did not compare Avanti to latex condoms and did not test for pregnancy and STD protection. Test results submitted to the FDA by the company indicated that, although Avanti is more than 1/3 less elastic than latex condoms, it did not break more frequently in an in-use study involving 187 couples.

75 FR 6401 - Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of...

Science.gov (United States)

2010-02-09

... Biologics Evaluation and Research (HFM-17), Food and Drug Administration, suite 200N, 1401 Rockville Pike... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-M-0513] Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Summaries...

76 FR 6477 - Industry Exchange Workshop on Food and Drug Administration Drug and Device Requirements; Public...

Science.gov (United States)

2011-02-04

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Industry Exchange Workshop on Food and Drug Administration Drug and Device Requirements; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. SUMMARY: The Food and Drug...

Novel material and structural design for large-scale marine protective devices

International Nuclear Information System (INIS)

Qiu, Ang; Lin, Wei; Ma, Yong; Zhao, Chengbi; Tang, Youhong

2015-01-01

Highlights: • Large-scale protective devices with different structural designs have been optimized. • Large-scale protective devices with novel material designs have been optimized. • Protective devices constructed of sandwich panels have the best anti-collision performance. • Protective devices with novel material design can reduce weight and construction cost. - Abstract: Large-scale protective devices must endure the impact of severe forces, large structural deformation, the increased stress and strain rate effects, and multiple coupling effects. In evaluation of the safety of conceptual design through simulation, several key parameters considered in this research are maximum impact force, energy dissipated by the impactor (e.g. a ship) and energy absorbed by the device and the impactor stroke. During impact, the main function of the ring beam structure is to resist and buffer the impact force between ship and bridge pile caps, which could guarantee that the magnitude of impact force meets the corresponding requirements. The means of improving anti-collision performance can be to increase the strength of the beam section or to exchange the steel material with novel fiber reinforced polymer laminates. The main function of the buoyancy tank is to absorb and transfer the ship’s kinetic energy through large plastic deformation, damage, or friction occurring within itself. The energy absorption effect can be improved by structure optimization or by the use of new sandwich panels. Structural and material optimization schemes are proposed on the basis of conceptual design in this research, and protective devices constructed of sandwich panels prove to have the best anti-collision performance

78 FR 38994 - Implanted Blood Access Devices for Hemodialysis; Draft Guidance for Industry and Food and Drug...

Science.gov (United States)

2013-06-28

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0749] Implanted Blood Access Devices for Hemodialysis; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...

78 FR 68459 - Medical Device Development Tools; Draft Guidance for Industry, Tool Developers, and Food and Drug...

Science.gov (United States)

2013-11-14

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-1279] Medical Device Development Tools; Draft Guidance for Industry, Tool Developers, and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...

76 FR 77542 - Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use Device...

Science.gov (United States)

2011-12-13

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0847] Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use Device Designations; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

Changes in FDA enforcement activities following changes in federal administration: the case of regulatory letters released to pharmaceutical companies.

Science.gov (United States)

Nguyen, Diane; Seoane-Vazquez, Enrique; Rodriguez-Monguio, Rosa; Montagne, Michael

2013-01-22

The United States (US) Food and Drug Administration (FDA) is responsible for the protection of the public health by assuring the safety, effectiveness and security of human drugs and biological products through the enforcement of the Federal Food, Drug and Cosmetic Act (FDCA) and related regulations. These enforcement activities include regulatory letters (i.e. warning letters and notice of violation) to pharmaceutical companies. A regulatory letter represents the FDA's first official notification to a pharmaceutical company that the FDA has discovered a product or activity in violation of the FDCA.This study analyzed trends in the pharmaceutical-related regulatory letters released by the FDA during the period 1997-2011 and assessed differences in the average number and type of regulatory letters released during the last four federal administrations. Data derived from the FDA webpage. Information about the FDA office releasing the letter, date, company, and drug-related violation was collected. Regulatory letters were classified by federal administration. Descriptive statistics were performed for the analysis. Between 1997 and 2011 the FDA released 2,467 regulatory letters related to pharmaceuticals. FDA headquarters offices released 50.6% and district offices 49.4% of the regulatory letters. The Office of Prescription Drug Promotion released the largest number of regulatory letters (850; 34.5% of the total), followed by the Office of Scientific Investigations (131; 5.3%), and the Office of Compliance (105; 4.3%). During the 2nd Clinton Administration (1997-2000) the average number of regulatory letters per year was 242.8 ± 45.6, during the Bush Administration (2001-2008) it was 120.4 ± 33.7, and during the first three years of the Obama administration (2009-2011) it was 177.7.0 ± 17.0. The average number of regulatory letters released by the Office of Prescription Drug Promotion also varied by administration: Clinton (122.3 ± 36.4), Bush (29.5�

76 FR 62073 - Guidance for Industry on Implementation of the Fee Provisions of the FDA Food Safety...

Science.gov (United States)

2011-10-06

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0721] Guidance for Industry on Implementation of the Fee Provisions of the FDA Food Safety Modernization Act; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

Pharmacokinetics of pediatric lopinavir/ritonavir tablets in children when administered twice daily according to FDA weight bands

NARCIS (Netherlands)

Bastiaans, D.E.T.; Forcat, S.; Lyall, H.; Cressey, T.R.; Hansudewechakul, R.; Kanjanavanit, S.; Noguera-Julian, A.; Konigs, C.; Inshaw, J.R.; Chalermpantmetagul, S.; Saidi, Y.; Compagnucci, A.; Harper, L.M.; Giaquinto, C.; Colbers, A.P.; Burger, D.M.

2014-01-01

BACKGROUND: Lopinavir/ritonavir (LPV/r) pediatric tablets (100/25 mg) are approved by the United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) as part of combination antiretroviral therapy. Dosing is based on body weight bands or body surface area under FDA approval

[Discussion about traditional Chinese medicine pharmacokinetics study based on first botanical drug approved by FDA].

Science.gov (United States)

Huang, Fanghua

2010-04-01

Pharmacokinetics study is one of main components of pharmaceuticals development. Food and Drug Administration (FDA) approved Veregen as the first botanical drug in 2006. This article introduced FDA's requirement on pharmacokinetics study of botanical drug and pharmacokinetics studies of Veregen, summarized current requirement and status quo of pharmacokinetics study on traditional Chinese medicine (TCM) and natural medicine in China, and discussed about pharmacokinetics study strategy for TCM and natural medicine.

MedWatch, the FDA Safety Information and Adverse Event Reporting Program

Science.gov (United States)

... Reporting Program MedWatch: The FDA Safety Information and Adverse Event Reporting Program Share Tweet Linkedin Pin it ... approved information that can help patients avoid serious adverse events. Potential Signals of Serious Risks/New Safety ...

Design controls for the medical device industry

CERN Document Server

Teixeira, Marie B

2013-01-01

The second edition of a bestseller, Design Controls for the Medical Device Industry provides a comprehensive review of the latest design control requirements, as well as proven tools and techniques to ensure your company's design control program evolves in accordance with current industry practice. The text assists in the development of an effective design control program that not only satisfies the US FDA Quality System Regulation (QSR) and ISO 9001 and 13485 standards, but also meets today's third-party auditor/investigator expectations and saves you valuable time and money.The author's cont

Technical trends of large-size photomasks for flat panel displays

Science.gov (United States)

Yoshida, Koichiro

2017-06-01

Currently, flat panel displays (FPDs) are one of the main parts for information technology devices and sets. From 1990's to 2000's, liquid crystal displays (LCDs) and plasma displays had been mainstream FPDs. In the middle of 2000's, demand of plasma displays declined and organic light emitting diodes (OLEDs) newly came into FPD market. And today, major technology of FPDs are LCDs and OLEDs. Especially for mobile devices, the penetration of OLEDs is remarkable. In FPDs panel production, photolithography is the key technology as same as LSI. Photomasks for FPDs are used not only as original master of circuit pattern, but also as a tool to form other functional structures of FPDs. Photomasks for FPDs are called as "Large Size Photomasks(LSPMs)", since the remarkable feature is " Size" which reaches over 1- meter square and over 100kg. In this report, we discuss three LSPMs technical topics with FPDs technical transition and trend. The first topics is upsizing of LSPMs, the second is the challenge for higher resolution patterning, and the last is "Multi-Tone Mask" for "Half -Tone Exposure".

78 FR 76993 - Defense Federal Acquisition Regulation Supplement: Photovoltaic Devices (DFARS Case 2014-D006)

Science.gov (United States)

2013-12-20

... DFARS, some questions have arisen as to where the substantial transformation of some solar panels occurs... contract exceeds $25,000, the Offeror's certification that such photovoltaic device (e.g., solar panel) is...

Comparison of the FDA and ASCO/CAP Criteria for HER2 Immunohistochemistry in Upper Urinary Tract Urothelial Carcinoma

Directory of Open Access Journals (Sweden)

Gilhyang Kim

2016-11-01

Full Text Available Background Human epidermal growth factor receptor 2 (HER2 is one of the known oncogenes in urothelial carcinoma. However, the association between HER2 and the prognosis of upper urinary tract urothelial carcinoma (UUTUC has not yet been fully clarified. The aim of this study was to evaluate HER2 expression using the United States Food and Drug Administration (FDA criteria and American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP criteria and compare their prognostic significance in UUTUC. Methods HER2 expression was evaluated in 144 cases of UUTUC by immunohistochemistry (IHC using tissue microarrays. We separately analyzed HER2 expression using the FDA and ASCO/CAP criteria. The IHC results were categorized into low (0, 1+ and high (2+, 3+ groups. Results Using the FDA criteria, 94 cases were negative, 38 cases were 1+, nine cases were 2+, and three cases were 3+. Using the ASCO/CAP criteria, 94 cases were negative, 34 cases were 1+, 13 cases were 2+, and three cases were 3+. Four cases showing 2+ according to the ASCO/CAP criteria were reclassified as 1+ by the FDA criteria. High HER2 expression by both the FDA criteria and ASCO/CAP criteria was significantly associated with International Society of Urological Pathology high grade (p = .001 and p < .001. The high HER2 expression group classified with the FDA criteria showed significantly shorter cancer-specific survival (p = .004, but the HER2 high and low expression groups classified with the ASCO/CAP criteria did not show significant differences (p = .161 in cancer-specific survival. Conclusions HER2 high expression groups were significantly associated with shorter cancer-specific survival, and our study revealed that the FDA criteria are more suitable for determining HER2 expression in UUTUC.

Front panel human interface for FASTBUS

International Nuclear Information System (INIS)

Gustavson, D.B.; Holmes, T.L.; Paffrath, L.; Steffani, J.P.

1980-01-01

A human interface based on the Snoop diagnostic module has been designed to facilitate checkout of FASTBUS devices, diagnosis of system faults, and monitoring of system performance. This system, which is a generalization of the usual computer front panel or control console, includes logic analyzer functions, display and manual-control access to other modules, a microprocessor which allows the user to create and execute diagnostic programs and store them on a minifloppy disk, and a diagnostic network which allows remote console operation and coordination of information from multiple segments' Snoops

Agreements and Discrepancies between FDA Reports and Journal Papers on Biologic Agents Approved for Rheumatoid Arthritis: A Meta-Research Project.

Directory of Open Access Journals (Sweden)

Gil Amarilyo

Full Text Available Sponsors that seek to commercialize new drugs apply to the Food and Drug Administration (FDA which independently analyzes the raw data and reports the results on its website.This study sought to determine if there are differences between the FDA assessments and journal reports on biologic agents developed for the treatment of rheumatoid arthritis.Available data on FDA-approved drugs were extracted from the website, and a systematic literature search was conducted to identify matching studies in peer-reviewed medical journals. Outcome measures were the American College of Rheumatology response criteria ACR20 (efficacy and withdrawal due to adverse events (safety. As effect size odds ratios were estimated for each active trial arm vs. control arm (i.e. for both sources: FDA and journal report, followed by calculation of the ratios of the FDA and journal report odds ratios. A ratio of odds ratios not equal to 1 was categorized as a discrepancy.FDA reports were available for 8 of 9 FDA-approved biologic agents for rheumatoid arthritis; all identified trials (34 except one were published in peer-reviewed journals. Overall, discrepancies were noted for 20 of the 33 evaluated trials. Differences in the apparent benefit reporting were found in 39% (24/61 pairwise comparisons and in 11 cases these were statistically significant; the FDA report showed greater benefit than the journal publication in 15 comparisons and lesser benefit in 9. Differences in the reported harms were found in 51% (28/55 pairwise comparisons and were statistically significant in 5. The "signal" in FDA reports showed a less harmful effect than the journal publication in 17 comparisons whereas a more harmful effect in 11. The differences were attributed to differences in analytic approach, patient inclusion, rounding effect, and counting discrepancies. However, no differences were categorized as critical.There was no empirical evidence to suggest biased estimates between the two

A device for heat-proofing the closing slab of a fast neutron nuclear reactor

International Nuclear Information System (INIS)

Lemercier, Guy.

1973-01-01

A device proofing the closing-slab comprising a metal-shoe against which is applied said device, the latter being constituted by a plurality of panels, each of which is formed by a padding of superimposed metal-cloths arranged in parallel relationship to the slab to be heat-proofed. Said device is characterized in that each panel is contained in a casing applied against the slab, constituted by two metal half-boxes of parallelepipedic shape embedded into each other. This can be applied to high-power reactors for protecting the slab against the aerosols of the coolant liquid-metal [fr

Petitioning the FDA to Improve Pharmaceutical, Device and Public Health Safety by Ordinary Citizens: A Descriptive Analysis.

Science.gov (United States)

Chen, Brian K; Yang, Y Tony; Cheng, Xi; Bian, John; Bennett, Charles L

2016-01-01

The United States Constitution protects the right of citizens to petition the government for "a redress of grievances." This right has important implications for citizens desiring to advance the public health by petitioning administrative agencies, such as the Food and Drug Administration, to take safety actions. We examined a total of 1,915 petitions filed between 2001 and 2013 to investigate the outcomes of citizen petitions that address public health concerns. We found that most petitions were filed by manufacturers against other manufacturers. Only 346 (18%) of all petitions were submitted by individuals and non-profit organizations, and 178 (87.3%) of these petitions with a final response were denied. On average, these petitions required 2.85 years for a final agency decision, and many decisions remain pending 10-13 years after their initial submission. The great majority of the approved requests included some form of risk communication, such as labeling changes, boxed warnings or placement of a drug into a Risk Evaluation and Mitigation Strategy. As a policy instrument to improve the safety of medical and food products, the citizen petition process requires sophisticated legal and scientific expertise, and may not represent a viable route for ordinary citizens to petition the FDA to "redress grievances."

Thermonuclear device

International Nuclear Information System (INIS)

Tezuka, Masaru.

1993-01-01

Protrusions and recesses are formed to a vacuum vessel and toroidal magnetic coils, and they are engaged. Since the vacuum vessel is generally supported firmly by a rack or the like by support legs, the toroidal magnetic field coils can be certainly supported against tumbling force. Then, there can be attained strong supports for the toroidal magnetic field coils, in addition to support by wedges on the side of inboard and support by share panels on the side of outboard, capable of withstanding great electromagnetic forces which may occur in large-scaled next-generation devices. That is, toroidal magnetic field coils excellent from a view point of deformation and stress can be obtained, to provide a thermonuclear device of higher reliability. (N.H.)

76 FR 16350 - Medical Devices; Ovarian Adnexal Mass Assessment Score Test System; Labeling; Black Box Restrictions

Science.gov (United States)

2011-03-23

... inflation) in any one year.'' The current threshold after adjustment for inflation is $135 million, using the most current (2009) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect... proposes to amend 21 CFR part 866 as follows. PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES 1. The...

Timelines of translational science: From technology initiation to FDA approval.

Directory of Open Access Journals (Sweden)

Laura M McNamee

Full Text Available While timelines for clinical development have been extensively studied, there is little data on the broader path from initiation of research on novel drug targets, to approval of drugs based on this research. We examined timelines of translational science for 138 drugs and biologicals approved by the FDA from 2010-2014 using an analytical model of technology maturation. Research on targets for 102 products exhibited a characteristic (S-curve maturation pattern with exponential growth between statistically defined technology initiation and established points. The median initiation was 1974, with a median of 25 years to the established point, 28 years to first clinical trials, and 36 years to FDA approval. No products were approved before the established point, and development timelines were significantly longer when the clinical trials began before this point (11.5 vs 8.5 years, p<0.0005. Technological maturation represents the longest stage of translation, and significantly impacts the efficiency of drug development.

Ten years after the FDA black box warning for antidepressant drugs: a critical narrative review

Directory of Open Access Journals (Sweden)

Juan Carlos Martínez-Aguayo

2016-06-01

Full Text Available ABSTRACT Background The United States Food and Drug Administration (FDA has warned about the increased suicidality risk associated with the use of selective serotonin reuptake inhibitors (SSRI and venlafaxine in children and adolescents. Objectives To critically appraise the available evidence supporting the FDA Black box warning concerning to the use of antidepressants in child and adolescents. Methods A critical review of articles in Medline/PubMed and SciELO databases regarding the FDA Black box warning for antidepressants, and the impact of FDA warnings on antidepressant prescriptions and suicide rates. Results The warning was based on surveys that did not report either cases of suicide nor a significant difference supporting an increased suicidality rate. The concept was defined in an ambiguous way and there is currently more available evidence to support such definition. The use of SSRI and venlafaxine has been associated to lower suicidality rates, but the prescription fall due to the warning increased suicide rates. Discussion Suicidality is an inherent feature of depressive disorders so it would be desirable to consider how much of the phenomenon may be attributed to antidepressants per se. It would be appropriate to consider that suicide rates might increase also as a consequence of the warning.

Panel and planar experimental shear behavior of wood panels ...

African Journals Online (AJOL)

Panel shear strength along the thickness and planar shear along the length of wood panels laminated softwood oriented OSB 10 mm thick, conditioned at different moisture contents (anhydrous medium, ambient temperature and humid medium) was measured on standardized test specimens, cut in half lengthwise panel ...

A virtual control panel configuration tool for the X-Window system

International Nuclear Information System (INIS)

Hill, J.O.; Dalesio, L.R.; Kerstiens, D.M.

1992-01-01

Computer Graphics Workstations are becoming increasingly popular for use as virtual process control and read back panels. The workstation's CRT, keyboard, and pointing device are used in concert to produce a display that is in essence a control panel, even if actual switches and gauges are not present. The code behind these displays is most often specific to one display and not reusable for any other display. Recently, programs have been written allowing many of these virtual control panel displays to be configured without writing additional code. This approach allows the initial programming effort to be reapplied to many different display instances with minimal effort. These programs often incorporate many of the features of a graphics editor, allowing a pictorial model of the process under control to be incorporated into the control panel. We have just finished writing a second generation software system of this type for use with the X-window system and the Experimental Physics and Industrial Control System (EPICS). This paper describes the primary features of our software, the framework of our design, and our observations after initial installation. (author)

The FDA's failure to address the lack of generalisability of antidepressant efficacy trials in product labelling.

Science.gov (United States)

Zimmerman, Mark

2016-06-01

According to the US Food and Drug Administration's (FDA's) regulations, the criteria used to select patients into registration studies should be addressed in a product's label. The FDA's labelling guidelines, which specifically indicate that the routine exclusion of patients of a certain level of severity should be noted in the label, has been uniformly ignored. © The Royal College of Psychiatrists 2016.

76 FR 81511 - Draft Guidance for Industry and Food and Drug Administration Staff; Center for Devices and...

Science.gov (United States)

2011-12-28

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0893] Draft Guidance for Industry and Food and Drug Administration Staff; Center for Devices and Radiological... appropriate, and other forms of information technology. Draft Guidance for Industry and Food and Drug...

Pressurized waterproof case electronic device

KAUST Repository

Berumen, Michael L.

2013-01-31

A pressurized waterproof case for an electronic device is particularly adapted for fluid-tight containment and operation of a touch-screen electronic device or the like therein at some appreciable water depth. In one example, the case may be formed as an enclosure having an open top panel or face covered by a flexible, transparent membrane or the like for the operation of the touchscreen device within the case. A pressurizing system is provided for the case to pressurize the case and the electronic device therein to slightly greater than ambient in order to prevent the external water pressure from bearing against the transparent membrane and pressing it against the touch screen, thereby precluding operation of the touch screen device within the case. The pressurizing system may include a small gas cartridge or may be provided from an external source.

Impact of FDA Actions, DTCA, and Public Information on the Market for Pain Medication.

Science.gov (United States)

Bradford, W David; Kleit, Andrew N

2015-07-01

Nonsteroidal anti-inflammatory drugs (NSAIDs) are one of the most important classes of prescription drugs used by primary care physicians to manage pain. The NSAID class of products has a somewhat controversial history, around which a complex regulatory and informational environment has developed. This history includes a boxed warning mandated by the Food and Drug Administration (FDA) for all NSAIDs in 2005. We investigate the impact that various information shocks have had on the use of prescription medications for pain in primary care in the USA. We accomplish this by extracting data on nearly 600,000 patients from a unique nationwide electronic medical record database and estimate the probability of any active prescription for the four types of pain medications as a function of FDA actions, advertising, media coverage, and patient characteristics. We find that even after accounting for multiple sources of information, the FDA label changes and boxed warnings had a significant effect on pain medication prescribing. The boxed warning did not have the same impact on the use of all NSAID inhibitors. We find that the boxed warning reduced the use of NSAID COX-2 inhibitor use, which was the focus of much of the press attention. In contrast, however, the warning actually increased the use of non-COX-2 NSAID inhibitors. Thus, the efficacy of the FDA's black box warning is clearly mixed. Copyright © 2014 John Wiley & Sons, Ltd.

Optimum design of composite panel with photovoltaic-thermo module. Absorbing effect of cooling panel; Hikari netsu fukugo panel no saiteki sekkei. Reikyaku panel no kyunetsu koka

Energy Technology Data Exchange (ETDEWEB)

Sato, M; Kikuchi, S; Tani, T [Science University of Tokyo, Tokyo (Japan); Kadotani, K; Imaizumi, H [Komatsu Ltd., Tokyo (Japan)

1996-10-27

The composite panel with photovoltaic-thermo module becomes higher in energy-saving than the conventional air-conditioning system by the independent radiational heating and cooling effect obtained when the generating panel using a solar cell module is combined with the heating and cooling panel using a thermo-element module. The output of a solar cell module can be directly used because the solar cell module operates in AC. This paper reports the relation between the absorbed value and power consumption of the cooling panel, while paying attention to the cooling panel. The performance coefficient of the maximum absorbed value from an non-absorbing substance to a cooling panel is 2 to 3. Assume that the cooling panel during non-adiabatic operation is operated using a solar cell module of 800 W/m{sup 2} in solar intensity and 15% in conversion efficiency. The cooling-surface temperature difference is 12.12 K, and the maximum absorbed value of a non-absorbing substance to a cooling panel is 39.12 W/m{sup 2}. The absorbed value of the outer temperature to the cooling panel is 74.4 W/m{sup 2}, and each performance coefficient is 3.26 and 0.62. The absorbed value must be calculated for evaluation from the cooling-surface temperature difference measured directly from the cooling panel. 4 refs., 8 figs., 1 tab.

Diffractive flat panel solar concentrators of a novel design.

Science.gov (United States)

de Jong, Ties M; de Boer, Dick K G; Bastiaansen, Cees W M

2016-07-11

A novel design for a flat panel solar concentrator is presented which is based on a light guide with a grating applied on top that diffracts light into total internal reflection. By combining geometrical and diffractive optics the geometrical concentration ratio is optimized according to the principles of nonimaging optics, while the thickness of the device is minimized due to the use of total internal reflection.

78 FR 24425 - Assay Migration Studies for In Vitro Diagnostic Devices; Guidance for Industry and Food and Drug...

Science.gov (United States)

2013-04-25

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0642] Assay Migration Studies for In Vitro Diagnostic Devices; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...

FDA Accelerates Testing and Review of Experimental Brain Cancer Drug | FNLCR

Science.gov (United States)

An investigational brain cancer drug made with disabled polio virus and manufactured at the Frederick National Lab has won breakthrough status from the Food and Drug Administration (FDA) to fast-track its further refinement and clinical testing.  Br

Device Optimization and Transient Electroluminescence Studies of Organic light Emitting Devices

Energy Technology Data Exchange (ETDEWEB)

Lijuan Zou

2003-08-05

Organic light emitting devices (OLEDs) are among the most promising for flat panel display technologies. They are light, bright, flexible, and cost effective. And while they are emerging in commercial product, their low power efficiency and long-term degradation are still challenging. The aim of this work was to investigate their device physics and improve their performance. Violet and blue OLEDs were studied. The devices were prepared by thermal vapor deposition in high vacuum. The combinatorial method was employed in device preparation. Both continuous wave and transient electroluminescence (EL) were studied. A new efficient and intense UV-violet light emitting device was developed. At a current density of 10 mA/cm{sup 2}, the optimal radiance R could reach 0.38 mW/cm{sup 2}, and the quantum efficiency was 1.25%. using the delayed EL technique, electron mobilities in DPVBi and CBP were determined to be {approx} 10{sup -5} cm{sup 2}/Vs and {approx} 10{sup -4} cm{sup 2}/Vs, respectively. Overshoot effects in the transient El of blue light emitting devices were also observed and studied. This effect was attributed to the charge accumulation at the organic/organic and organic/cathode interfaces.

Device Optimization and Transient Electroluminescence Studies of Organic light Emitting Devices

International Nuclear Information System (INIS)

Lijuan Zou

2003-01-01

Organic light emitting devices (OLEDs) are among the most promising for flat panel display technologies. They are light, bright, flexible, and cost effective. And while they are emerging in commercial product, their low power efficiency and long-term degradation are still challenging. The aim of this work was to investigate their device physics and improve their performance. Violet and blue OLEDs were studied. The devices were prepared by thermal vapor deposition in high vacuum. The combinatorial method was employed in device preparation. Both continuous wave and transient electroluminescence (EL) were studied. A new efficient and intense UV-violet light emitting device was developed. At a current density of 10 mA/cm 2 , the optimal radiance R could reach 0.38 mW/cm 2 , and the quantum efficiency was 1.25%. using the delayed EL technique, electron mobilities in DPVBi and CBP were determined to be ∼ 10 -5 cm 2 /Vs and ∼ 10 -4 cm 2 /Vs, respectively. Overshoot effects in the transient El of blue light emitting devices were also observed and studied. This effect was attributed to the charge accumulation at the organic/organic and organic/cathode interfaces

Maternal characteristics associated with pregnancy exposure to FDA category C, D, and X drugs in a Canadian population.

Science.gov (United States)

Yang, Tubao; Walker, Mark C; Krewski, Daniel; Yang, Qiuying; Nimrod, Carl; Garner, Peter; Fraser, William; Olatunbosun, Olufemi; Wen, Shi Wu

2008-03-01

To estimate the frequency of exposure to prescription Food and Drug Administration (FDA) category C, D, and X drugs in pregnant women, and to analyze the maternal characteristics associated with such an exposure. A 50% random sample of women who gave a birth in Saskatchewan between January 1, 1997 and December 31, 2000 was chosen for the study. The rate of exposure to FDA category C, D, or X drugs recorded in the pharmacist database was estimated. Associations of exposure to FDA category C, D, and X drugs with maternal characteristics were evaluated using multiple logistical regression, with adjusted odds ratios (ORs) and its 95% confidence intervals (CIs) as the association measures. A total of 18 575 women were included in this study. Among them, 3604 (19.4%) had exposure to one or more FDA category C, D, and X drugs during pregnancy. Category C drugs were the most frequently used drugs (15.8%), followed by D drugs (5.2%), and X drugs (3.9%). Women with chronic health conditions had fourfold at increased risk of exposure than women without. Regardless of health status, women who were or =3, and who were on social assistance plan were at increased risk of pregnancy exposure to these drugs. About 19.4% pregnant women are exposed to FDA C, D or X drugs during pregnancy. Women with chronic diseases, younger age, increased parity, and under social assistance are at increased risk of exposure to FDA C, D, or X drugs. Copyright 2008 John Wiley & Sons, Ltd.

FDA Developments: Food Code 2013 and Proposed Trans Fat Determination

NARCIS (Netherlands)

Grossman, M.R.

2014-01-01

268 Reports EFFL 4|2014 USA FDA Developments: Food Code 2013 and Proposed Trans Fat Determination Margaret Rosso Grossman* I. Food Code 2013 and Food Code Reference System Since 1993, the US Food and Drug Administration has published a Food Code, now updated every four years. In November 2013, the

Report of panel 1: The appropriate scope and mission of ITER

Energy Technology Data Exchange (ETDEWEB)

Linford, R.K. (Los Alamos National Lab., NM (United States)); Weitzner, H.; Abdou, M.A.; Baldwin, D.E.; Berkner, K.H.; Berry, L.A.; Culler, F.L.; Dean, S.O.; DeFreece, D.A.; Gauster, W.B. (and others)

1992-12-01

This panel looked at the mission of ITER, and how the US should address the present plans, and considers a number of alternative plans to arrive at the eventual goals of ITER. The panel considered three major approaches which have been discussed on the international scale, and tries to present the strengths, weaknesses, and possible changes to these plans. It suggests that any of these plans can arrive at the eventual aim, but may involve differing risks and time commitments. All plans involve ITER design studies, development work on technologies which must be in place for ITER design to succeed, and testing of materials and components for application in the device.

Report of panel 1: The appropriate scope and mission of ITER

International Nuclear Information System (INIS)

Linford, R.K.; Weitzner, H.; Abdou, M.A.; Baldwin, D.E.; Berkner, K.H.; Berry, L.A.; Culler, F.L.; Dean, S.O.; DeFreece, D.A.; Gauster, W.B.

1992-01-01

This panel looked at the mission of ITER, and how the US should address the present plans, and considers a number of alternative plans to arrive at the eventual goals of ITER. The panel considered three major approaches which have been discussed on the international scale, and tries to present the strengths, weaknesses, and possible changes to these plans. It suggests that any of these plans can arrive at the eventual aim, but may involve differing risks and time commitments. All plans involve ITER design studies, development work on technologies which must be in place for ITER design to succeed, and testing of materials and components for application in the device

Direct-to-Consumer Broadcast Advertisements for Pharmaceuticals: Off-Label Promotion and Adherence to FDA Guidelines.

Science.gov (United States)

Klara, Kristina; Kim, Jeanie; Ross, Joseph S

2018-05-01

Direct-to-consumer (DTC) advertisements for prescription drugs in the United States are regulated by the Food and Drug Administration (FDA). Off-label promotion, or the advertisement of a drug for an indication not approved by the FDA, is prohibited. Our objective was to examine the presence of off-label promotion in broadcast DTC ads and to assess their adherence to FDA guidelines mandating fair balance in presentation of risks and benefits and prohibiting misleading advertisement claims. All English-language broadcast DTC ads for prescription drugs that aired in the United States from January 2015 to July 2016 were obtained from AdPharm, an online collection of healthcare advertisements. Ad length was measured and adherence to FDA guidelines was assessed for several categories: key regulatory items, indicators of false or misleading ads, and indicators of fair balance in presentation of risks and benefits. Our sample included 97 unique DTC ads, representing 60 unique drugs and 67 unique drug-indication combinations. No ads described drug risks quantitatively, whereas drug efficacy was presented quantitatively in 25 (26%) ads. Thirteen (13%) ads, all for diabetes medications, suggested off-label uses for weight loss and blood pressure reduction. The most commonly advertised drugs were indicated for the treatment of inflammatory conditions (n = 12; 18%), diabetes or diabetic neuropathy (n = 11; 16%), bowel or bladder dysfunction (n = 6; 9%), and infections or allergic reaction (n = 6; 9%). More than three-quarters (n = 51; 76%) advertised drugs to treat chronic conditions. Few broadcast DTC ads were fully compliant with FDA guidelines. The overall quality of information provided in ads was low, and suggestions of off-label promotion were common for diabetes medications. The impact of current DTC ads and off-label marketing on patient and prescriber decisions merits further scrutiny.

America, you are digging your grave with your spoon--should the FDA tell you that on food labels?

Science.gov (United States)

Card, Melissa M

2013-01-01

R.J. Reynolds Tobacco Co. v. Food & Drug Admin. discussed whether the FDA's promulgation of graphic images violated tobacco companies' First Amendment rights. While the tobacco companies contested the graphic images, the tobacco companies did not contest the promulgation of nine textual statements about the adverse effects of cigarettes. This uncontested mandate opens a door for the FDA to further expand its regulatory scheme. If the FDA can mandate textual statements about the adverse effects of cigarettes, can the FDA mandate textual statements about the adverse effects of sugar to combat the obesity crisis? This Article presents three textual statements about the adverse effects of sugar, to define the line between acceptable and unacceptable forms of compelled commercial speech under Central Hudson. Establishing this line ensures that the commercial speech doctrine does not deny the FDA from its authority to provide consumers with accurate information. While three textual statements are presented, this Article advocates that one of the textual statements is likely to serve as the best solution to the obesity crisis. The chosen textual statement serves as an effective solution because it presents meaningful information to the consumers enabling consumers to make healthful decisions about their food and encourages manufacturers to modify their products.

Trends in utilization of smoking cessation agents before and after the passage of FDA boxed warning in the United States.

Science.gov (United States)

Shah, Drishti; Shah, Anuj; Tan, Xi; Sambamoorthi, Usha

2017-08-01

In 2009, the FDA required a black box warning (BBW) on bupropion and varenicline, the two commonly prescribed smoking cessation agents due to reports of adverse neuropsychiatric events. We investigated if there was a decline in use of bupropion and varenicline after the BBW by comparing the percent using these medications before and after BBW. We conducted a retrospective observational study using data from the Medical Expenditure Panel Survey from 2007 to 2014. The study sample consisted of adult smokers, who were advised by their physicians to quit smoking. We divided the time period into "pre-warning", "post-warning: immediate", and "post-warning: late." Unadjusted analysis using chi-square tests and adjusted analyses using logistic regressions were conducted to evaluate the change in bupropion and varenicline use before and after the BBW. Secondary analyses using piecewise regression were also conducted. On an average, 49.04% of smokers were advised by their physicians to quit smoking. We observed a statistically significant decline in varenicline use from 22.1% in year 2007 to 9.23% in 2014 (p valuesmoking by their physicians were less likely to use varenicline in the immediate post-BBW period as compared to pre-BBW period. While the use of varenicline continued to be significantly low in the late post-BBW period (AOR=0.45, 95% CI=0.31-0.64) as compared to the pre-BBW period, the trend in use as seen in piecewise regression remained stable (OR=0.90, 95% CI=0.75-1.06). We did not observe significant differences in bupropion use between the pre- and post-BBW periods. The passage of the FDA boxed warning was associated with a significant decline in the use of varenicline, but not in the use of bupropion. Copyright © 2017 Elsevier B.V. All rights reserved.

De besluitvorming over werkzaamheid en veiligheid van rosiglitazon bij de FDA en de EMA. Wat zijn de lessen?

NARCIS (Netherlands)

Pouwels, Koen; Van Grootheest, Kees

2013-01-01

The rosiglitazone decision process at FDA and EMA. What should we learn? In September 2010 the EMA decided to suspend the market authorisation of rosiglitazone while the FDA decided to restrict its use. These actions were taken because rosiglitazone had been associated with an increased risk of

75 FR 40844 - Town Hall Discussion With the Director of the Center for Devices and Radiological Health and...

Science.gov (United States)

2010-07-14

... communication between CDRH and the medical device industry. The meeting will open with an introduction of CDRH Senior Staff in attendance. Following introductions, Dr. Jeffrey Shuren, the Director of CDRH, will... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0321...

75 FR 24718 - Town Hall Discussion With the Director of the Center for Devices and Radiological Health and...

Science.gov (United States)

2010-05-05

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0224.../ideas for facilitating two-way communication between CDRH and the medical device industry. The meeting will open with an introduction of CDRH Senior Staff in attendance. Following introductions, Dr. Jeffrey...

75 FR 21006 - Town Hall Discussion With the Director of the Center for Devices and Radiological Health and...

Science.gov (United States)

2010-04-22

... communication between CDRH and the medical device industry. The meeting will open with an introduction of CDRH Senior Staff in attendance. Following introductions, Jeffrey Shuren, the Director of CDRH, will present... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001...

78 FR 102 - Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device...

Science.gov (United States)

2013-01-02

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1056] Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device Submissions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

Heparin crisis 2008: a tipping point for increased FDA enforcement in the pharma sector?

Science.gov (United States)

Rosania, Larry

2010-01-01

Against a backdrop of steady deregulation, the pharmaceutical industry is increasingly outsourcing manufacturing, resulting in decentralized control of the global supply chain. Established products such as heparin have been held to outdated analytical standards. Ten million Americans receive heparin every year; Baxter International accounts for half of this market. In 2008, contamination of Baxter's heparin--sourced in China--resulted in about 350 adverse events and 150 deaths in the United States. In future, increasingly stringent FDA inspections and enforcement are expected for imported drugs and ingredients. More regional FDA offices will be set up overseas. FDA funding will likely be supplemented in future by user fees charged to importers. For newer products, companies will face pressure to adopt Quality by Design, with solid control of the global supply chain and a proactive focus on GMP. Older products will be held to modern standards. Long-term, imports of drugs and ingredients from developing markets will continue. This makes sense to companies from an economic standpoint, but protections will be essential to ensure that it is also justifiable from a public health perspective.

Enhanced model of photovoltaic cell/panel/array considering the direct and reverse modes

Science.gov (United States)

Zegaoui, Abdallah; Boutoubat, Mohamed; Sawicki, Jean-Paul; Kessaissia, Fatma Zohra; Djahbar, Abdelkader; Aillerie, Michel

2018-05-01

This paper presents an improved generalized physical model for photovoltaic, PV cells, panels and arrays taking into account the behavior of these devices when considering their biasing existing in direct and reverse modes. Existing PV physical models generally are very efficient for simulating influence of irradiation changes on the short circuit current but they could not visualize the influences of temperature changes. The Enhanced Direct and Reverse Mode model, named EDRM model, enlightens the influence on the short-circuit current of both temperature and irradiation in the reverse mode of the considered PV devices. Due to its easy implementation, the proposed model can be a useful power tool for the development of new photovoltaic systems taking into account and in a more exhaustive manner, environmental conditions. The developed model was tested on a marketed PV panel and it gives a satisfactory results compared with parameters given in the manufacturer datasheet.

FDA drug safety communications: a narrative review and clinical considerations for older adults.

Science.gov (United States)

Marcum, Zachary A; Vande Griend, Joseph P; Linnebur, Sunny A

2012-08-01

The US Food and Drug Administration (FDA) has new regulatory authorities intended to enhance drug safety monitoring in the postmarketing period. This has resulted in an increase in communication from the FDA in recent years about the safety profile of certain drugs. It is important to stay abreast of the current literature on drug risks to effectively communicate these risks to patients, other health care providers, and the general public. To summarize 4 new FDA drug safety communications by describing the evidence supporting the risks and the clinical implications for older adults. The FDA Web site was reviewed for new drug safety communications from May 2011 to April 2012 that would be relevant to older adults. Approved labeling for each drug or class was obtained from the manufacturer, and PubMed was searched for primary literature that supported the drug safety concern. FDA drug safety communications for 4 drugs were chosen because of the potential clinical importance in older adults. A warning for citalopram was made because of potential problems with QT prolongation in patients taking less than 40 mg per day. The evidence suggests minor changes in QT interval. Given the flat dose-response curve in treating depression with citalopram, the new 20-mg/d maximum dose in older adults is sensible. Another warning was made for proton pump inhibitors (PPIs) and an increased risk of Clostridium difficile infection. A dose-response relationship was found for this drug risk. With C. difficile infections on the rise in older adults, along with other safety risks of PPI therapy, PPIs should only be used in older adults indicated for therapy for the shortest duration possible. In addition, a warning about dabigatran was made. There is strong evidence from a large clinical trial, as well as case reports, of increased bleeding risk in older adults taking dabigatran, especially in older adults with decreased renal function. This medication should be used with caution in older

Pure- and Mixed-Gas Permeation Properties of Highly Selective and Plasticization Resistant Hydroxyl-Diamine-Based 6FDA Polyimides for CO2/CH4 Separation

KAUST Repository

Alaslai, Nasser Y.

2016-01-05

The effect of hydroxyl functionalization on the m-phenylene diamine moiety of 6FDA dianhydride-based polyimides was investigated for gas separation applications. Pure-gas permeability coefficients of He, H2, N2, O2, CH4, and CO2 were measured at 35 °C and 2 atm. The introduction of hydroxyl groups in the diamine moiety of 6FDA-diaminophenol (DAP) and 6FDA-diamino resorcinol (DAR) polyimides tightened the overall polymer structure due to increased charge transfer complex formation compared to unfunctionalized 6FDA-m-phenylene diamine (mPDA). The BET surface areas based on nitrogen adsorption of 6FDA-DAP (54 m2g−1) and of 6FDA-DAR (45 m2g−1) were ~18% and 32% lower than that of 6FDA-mPDA (66 m2g−1). 6FDA-mPDA had a pure-gas CO2 permeability of 14 Barrer and CO2/CH4 selectivity of 70. The hydroxyl-functionalized polyimides 6FDA-DAP and 6FDA-DAR exhibited very high pure-gas CO2/CH4 selectivities of 92 and 94 with moderate CO2 permeability of 11 and 8 Barrer, respectively. It was demonstrated that hydroxyl-containing polyimide membranes maintained very high CO2/CH4 selectivity (~ 75 at CO2 partial pressure of 10 atm) due to CO2 plasticization resistance when tested under high-pressure mixed-gas conditions. Functionalization with hydroxyl groups may thus be a promising strategy towards attaining highly selective polyimides for economical membrane-based natural gas sweetening.

Pure- and Mixed-Gas Permeation Properties of Highly Selective and Plasticization Resistant Hydroxyl-Diamine-Based 6FDA Polyimides for CO2/CH4 Separation

KAUST Repository

Alaslai, Nasser Y.; Ghanem, Bader; Alghunaimi, Fahd; Litwiller, Eric; Pinnau, Ingo

2016-01-01

The effect of hydroxyl functionalization on the m-phenylene diamine moiety of 6FDA dianhydride-based polyimides was investigated for gas separation applications. Pure-gas permeability coefficients of He, H2, N2, O2, CH4, and CO2 were measured at 35 °C and 2 atm. The introduction of hydroxyl groups in the diamine moiety of 6FDA-diaminophenol (DAP) and 6FDA-diamino resorcinol (DAR) polyimides tightened the overall polymer structure due to increased charge transfer complex formation compared to unfunctionalized 6FDA-m-phenylene diamine (mPDA). The BET surface areas based on nitrogen adsorption of 6FDA-DAP (54 m2g−1) and of 6FDA-DAR (45 m2g−1) were ~18% and 32% lower than that of 6FDA-mPDA (66 m2g−1). 6FDA-mPDA had a pure-gas CO2 permeability of 14 Barrer and CO2/CH4 selectivity of 70. The hydroxyl-functionalized polyimides 6FDA-DAP and 6FDA-DAR exhibited very high pure-gas CO2/CH4 selectivities of 92 and 94 with moderate CO2 permeability of 11 and 8 Barrer, respectively. It was demonstrated that hydroxyl-containing polyimide membranes maintained very high CO2/CH4 selectivity (~ 75 at CO2 partial pressure of 10 atm) due to CO2 plasticization resistance when tested under high-pressure mixed-gas conditions. Functionalization with hydroxyl groups may thus be a promising strategy towards attaining highly selective polyimides for economical membrane-based natural gas sweetening.

A Good Year: FDA Approved Nine New Cancer Drugs in 2014

Science.gov (United States)

In 2014, the Food and Drug Administration (FDA) approved 41 drugs that had not been approved previously for any indication, the most in nearly 20 years. Of these 41 novel drugs, 9 were approved for the treatment of cancer or cancer-related conditions.

Impact of the FDA warning of potential ceftriaxone and calcium interactions on drug use policy in clinical practice.

Science.gov (United States)

Esterly, John S; Steadman, Emily; Scheetz, Marc H

2011-06-01

In September 2007, the FDA issued an alert recommending that ceftriaxone and calcium-containing solutions should not be administered to any patient within 48 h of each other. Due to the widespread use of ceftriaxone, significant concern was expressed by the greater healthcare community about the warning, which the FDA eventually retracted in April of 2009. We sought to quantify the impact of the warning on healthcare institutions. A survey was administered to the membership of the Society of Infectious Diseases Pharmacists to quantify perceived changes in ceftriaxone use among healthcare institutions across the United States. A survey of Infectious Diseases experts was conducted. Participants were queried for hospital policies/drug use statistics during two times: immediately after the FDA warning and approximately 13 months post warning (preceding the FDA retraction). Related changes in formulary, drug-use policy, and the number of employee hours that were devoted to addressing the FDA warning were assessed. Ninety-four surveys representing 94 hospital systems were included in the analysis. Approximately half (n = 49, 52%) of respondent institutions enacted at least one drug-use policy change based on the warning; one institution removed ceftriaxone from a clinical protocol. Institutions' final interpretations of the warning differed slightly from initial understanding of the warning, and there was an overall minor decrease in the perceived use of ceftriaxone. The majority of those surveyed (n = 70, 74%) estimated that their respective institutions devoted between 1 and 49 employee hours to address the warning. Hospitals with ID pharmacists had minimal changes to ceftriaxone use after the 2007 FDA warning. Specialized pharmacists may be uniquely situated to help hospitals interpret global recommendations locally.

Stressed skin panels

Energy Technology Data Exchange (ETDEWEB)

Anon

2001-07-01

Advantages and disadvantages of stressed skin panels, also known as structural insulated panels (SIPs), are discussed as material and labour-saving alternatives to traditional stick framing. Stressed skin panels are manufactured 'sandwich' assemblies with a rigid insulating polystyrene foam core, whose interior and exterior surfaces are bonded into panels. The skins distribute and carry the structural loading while the bonded foam core provides insulation and keeps the two skins aligned. Since there are fewer framing members, there is little thermal bridging and the R-value remains high. SIPs are usually manufactured in four feet by eight feet panels, although some manufacturers can produce panels up to eight feet by forty feet. SIPs are resource efficient as they use less wood than conventional framing (about 25 per cent less); can structurally cover large spans, requiring less supplementary framing. Use of SIPs eliminate the need for headers over small openings; provide the ability to nail anywhere; create less scrap and waste; lessen vulnerability to unfavourable weather and other job-site hazards, can reduce delays, and often can produce significant savings in material and labour costs. Limitations include the more complex approaches to plumbing and electrical systems, although this can be minimized by designers by incorporating much of the plumbing and electrical work on interior (non-panel) walls. Most stressed skin panels require one-half inch interior gypsum drywall. If become wet, stressed skin panels take a long time to dry out and may harbour mold growth. Larger stressed-skin panels used in floors and roofs, may require cranes or other machinery for handling because of their weight. Although not without some environmental impact, overall, stressed skin panels are judged to be a resource-efficient building technology with significant energy-efficiency benefits and distinct advantages over stick framing. 3 photos.

Polycaprolactone Thin-Film Micro- and Nanoporous Cell-Encapsulation Devices.

Science.gov (United States)

Nyitray, Crystal E; Chang, Ryan; Faleo, Gaetano; Lance, Kevin D; Bernards, Daniel A; Tang, Qizhi; Desai, Tejal A

2015-06-23

Cell-encapsulating devices can play an important role in advancing the types of tissue available for transplantation and further improving transplant success rates. To have an effective device, encapsulated cells must remain viable, respond to external stimulus, and be protected from immune responses, and the device itself must elicit a minimal foreign body response. To address these challenges, we developed a micro- and a nanoporous thin-film cell encapsulation device from polycaprolactone (PCL), a material previously used in FDA-approved biomedical devices. The thin-film device construct allows long-term bioluminescent transfer imaging, which can be used for monitoring cell viability and device tracking. The ability to tune the microporous and nanoporous membrane allows selective protection from immune cell invasion and cytokine-mediated cell death in vitro, all while maintaining typical cell function, as demonstrated by encapsulated cells' insulin production in response to glucose stimulation. To demonstrate the ability to track, visualize, and monitor the viability of cells encapsulated in implanted thin-film devices, we encapsulated and implanted luciferase-positive MIN6 cells in allogeneic mouse models for up to 90 days. Lack of foreign body response in combination with rapid neovascularization around the device shows promise in using this technology for cell encapsulation. These devices can help elucidate the metrics required for cell encapsulation success and direct future immune-isolation therapies.

Science, law, and politics in the Food and Drug Administration's genetically engineered foods policy: FDA's 1992 policy statement.

Science.gov (United States)

Pelletier, David L

2005-05-01

The US Food and Drug Administration's (FDA's) 1992 policy statement was developed in the context of critical gaps in scientific knowledge concerning the compositional effects of genetic transformation and severe limitations in methods for safety testing. FDA acknowledged that pleiotropy and insertional mutagenesis may cause unintended changes, but it was unknown whether this happens to a greater extent in genetic engineering compared with traditional breeding. Moreover, the agency was not able to identify methods by which producers could screen for unintended allergens and toxicants. Despite these uncertainties, FDA granted genetically engineered foods the presumption of GRAS (Generally Recognized As Safe) and recommended that producers use voluntary consultations before marketing them.

77 FR 7584 - Draft Guidance for Industry on Heparin for Drug and Medical Device Use; Monitoring Crude Heparin...

Science.gov (United States)

2012-02-13

... strategies to ensure that the heparin supply chain is not contaminated with OSCS or any non- porcine origin... device manufacturers of finished products, and others to the potential risk of crude heparin...) among patients injected with heparin sodium in 2008, FDA identified the contaminant OSCS in heparin API...

Volumetry of human molars with flat panel-based volume CT in vitro

NARCIS (Netherlands)

Hannig, C.; Krieger, E.; Dullin, C.; Merten, H.A.; Attin, T.; Grabbe, E.; Heidrich, G.

2006-01-01

The flat panel-based volume computed tomography (fpVCT) is a new CT device applicable for experimental, three-dimensional evaluation of teeth at a resolution of about 150 microm in the high contrast region. The aim of this study was to investigate whether fpVCT was suitable for quantification of the

Advancing medical device innovation through collaboration and coordination of structured data capture pilots: Report from the Medical Device Epidemiology Network (MDEpiNet) Specific, Measurable, Achievable, Results-Oriented, Time Bound (SMART) Think Tank.

Science.gov (United States)

Reed, Terrie L; Drozda, Joseph P; Baskin, Kevin M; Tcheng, James; Conway, Karen; Wilson, Natalia; Marinac-Dabic, Danica; Heise, Theodore; Krucoff, Mitchell W

2017-12-01

The Medical Device Epidemiology Network (MDEpiNet) is a public private partnership (PPP) that provides a platform for collaboration on medical device evaluation and depth of expertise for supporting pilots to capture, exchange and use device information for improving device safety and protecting public health. The MDEpiNet SMART Think Tank, held in February, 2013, sought to engage expert stakeholders who were committed to improving the capture of device data, including Unique Device Identification (UDI), in key electronic health information. Prior to the Think Tank there was limited collaboration among stakeholders beyond a few single health care organizations engaged in electronic capture and exchange of device data. The Think Tank resulted in what has become two sustainable multi-stakeholder device data capture initiatives, BUILD and VANGUARD. These initiatives continue to mature within the MDEpiNet PPP structure and are well aligned with the goals outlined in recent FDA-initiated National Medical Device Planning Board and Medical Device Registry Task Force white papers as well as the vision for the National Evaluation System for health Technology.%. Published by Elsevier Inc.

Regulatory Challenges for Cartilage Repair Technologies.

Science.gov (United States)

McGowan, Kevin B; Stiegman, Glenn

2013-01-01

In the United States, few Food and Drug Administration (FDA)-approved options exist for the treatment of focal cartilage and osteochondral lesions. Developers of products for cartilage repair face many challenges to obtain marketing approval from the FDA. The objective of this review is to discuss the necessary steps for FDA application and approval for a new cartilage repair product. FDA Guidance Documents, FDA Panel Meetings, scientific organization recommendations, and clinicaltrials.gov were reviewed to demonstrate the current thinking of FDA and the scientific community on the regulatory process for cartilage repair therapies. Cartilage repair therapies can receive market approval from FDA as medical devices, drugs, or biologics, and the specific classification of product can affect the nonclinical, clinical, and regulatory strategy to bring the product to market. Recent FDA guidance gives an outline of the required elements to bring a cartilage repair product to market, although these standards are often very general. As a result, companies have to carefully craft their study patient population, comparator group, and clinical endpoint to best showcase their product's attributes. In addition, regulatory strategy and manufacturing process validation need to be considered early in the clinical study process to allow for timely product approval following the completion of clinical study. Although the path to regulatory approval for a cartilage repair therapy is challenging and time-consuming, proper clinical trial planning and attention to the details can eventually save companies time and money by bringing a product to the market in the most expeditious process possible.

Hemostasis of Left Atrial Appendage Bleed With Lariat Device

Directory of Open Access Journals (Sweden)

Amena Hussain, MD

2014-09-01

Full Text Available New devices designed for minimally invasive closure of the left atrial appendage (LAA may be a viable alternative for patients in whom anticoagulation is considered high risk. The Lariat (Sentreheart, Redwood City, CA, which is currently FDA-approved for percutaneous closure of tissue, requires both trans-septal puncture and epicardial access. However it requires no anticoagulation after the procedure. Here we describe a case of effusion and tamponade during a Lariat procedure with successful completion of the case and resolution of the effusion.

Integrated control rod monitoring device

International Nuclear Information System (INIS)

Saito, Katsuhiro

1997-01-01

The present invention provides a device in which an entire control rod driving time measuring device and a control rod position support device in a reactor building and a central control chamber are integrated systematically to save hardwares such as a signal input/output device and signal cables between boards. Namely, (1) functions of the entire control rod driving time measuring device for monitoring control rods which control the reactor power and a control rod position indication device are integrated into one identical system. Then, the entire devices can be made compact by the integration of the functions. (2) The functions of the entire control rod driving time measuring device and the control rod position indication device are integrated in a central operation board and a board in the site. Then, the place for the installation of them can be used in common in any of the cases. (3) The functions of the entire control rod driving time measuring device and the control rod position indication device are integrated to one identical system to save hardware to be used. Then, signal input/output devices and drift branching panel boards in the site and the central operation board can be saved, and cables for connecting both of the boards is no more necessary. (I.S.)

The "natural" aversion: the FDA's reluctance to define a leading food-industry marketing claim, and the pressing need for a workable rule.

Science.gov (United States)

Farris, April L

2010-01-01

As of 2009, the "natural foods" industry has become a 22.3 billion dollar giant and "all-natural" is the second-leading marketing claim for all new food products. Even in such a flourishing market, the Food and Drug Administration (FDA) has never defined the term "natural" through rulemaking. FDA and the U.S. Department of Agriculture (USDA) have instead created separate, non-identical policy statements governing the use of the term "natural," and FDA has abandoned efforts to define "natural" through rulemaking in the face of more pressing priorities. In absence of any governing federal standard, consumer advocacy groups and warring food industries have attempted to define "natural" to fit their preferences through high-stakes litigation of state law claims, leaving courts free to apply diverging standards without the expertise of FDA. Recent case law from federal district courts and the Supreme Court leaves little hope that FDA's current policy statement will preempt state law causes of action. To prevent a potential patchwork of definitions varying by state, and to create a legitimate standard resting on informed scientific expertise rather than consumer whims, FDA should engage in rulemaking to define the term "natural." This paper concludes by sketching potential formulations for such a rule based on FDA's previous successful rule-making ventures and standards used by natural foods retailers.

Comprehensive metabolic panel

Science.gov (United States)

Metabolic panel - comprehensive; Chem-20; SMA20; Sequential multi-channel analysis with computer-20; SMAC20; Metabolic panel 20 ... Chernecky CC, Berger BJ. Comprehensive metabolic panel (CMP) - blood. In: ... Tests and Diagnostic Procedures . 6th ed. St Louis, MO: ...

Noise Reduction in Double‿Panel Structures by Cavity and Panel Resonance Control

NARCIS (Netherlands)

Ho, J.; Berkhoff, Arthur P.

2011-01-01

This paper presents an investigation of the cavity and the panel resonance control in a double‿panel structure. The double‿panel structure, which consists of two panels with air in the gap, is widely adopted in many applications such as aerospace due to its light weight and effective

Noise reduction in double-panel structures by cavity and panel resonance control

NARCIS (Netherlands)

Ho, J.-H.; Berkhoff, A.P

2011-01-01

This paper presents an investigation of the cavity and the panel resonance control in a double‐panel structure. The double‐panel structure, which consists of two panels with air in the gap, is widely adopted in many applications such as aerospace due to its light weight and effective

Limited output transcranial electrical stimulation (LOTES-2017): Engineering principles, regulatory statutes, and industry standards for wellness, over-the-counter, or prescription devices with low risk.

Science.gov (United States)

Bikson, Marom; Paneri, Bhaskar; Mourdoukoutas, Andoni; Esmaeilpour, Zeinab; Badran, Bashar W; Azzam, Robin; Adair, Devin; Datta, Abhishek; Fang, Xiao Hui; Wingeier, Brett; Chao, Daniel; Alonso-Alonso, Miguel; Lee, Kiwon; Knotkova, Helena; Woods, Adam J; Hagedorn, David; Jeffery, Doug; Giordano, James; Tyler, William J

We present device standards for low-power non-invasive electrical brain stimulation devices classified as limited output transcranial electrical stimulation (tES). Emerging applications of limited output tES to modulate brain function span techniques to stimulate brain or nerve structures, including transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), and transcranial pulsed current stimulation (tPCS), have engendered discussion on how access to technology should be regulated. In regards to legal regulations and manufacturing standards for comparable technologies, a comprehensive framework already exists, including quality systems (QS), risk management, and (inter)national electrotechnical standards (IEC). In Part 1, relevant statutes are described for medical and wellness application. While agencies overseeing medical devices have broad jurisdiction, enforcement typically focuses on those devices with medical claims or posing significant risk. Consumer protections regarding responsible marketing and manufacture apply regardless. In Part 2 of this paper, we classify the electrical output performance of devices cleared by the United States Food and Drug Administration (FDA) including over-the-counter (OTC) and prescription electrostimulation devices, devices available for therapeutic or cosmetic purposes, and devices indicated for stimulation of the body or head. Examples include iontophoresis devices, powered muscle stimulators (PMS), cranial electrotherapy stimulation (CES), and transcutaneous electrical nerve stimulation (TENS) devices. Spanning over 13 FDA product codes, more than 1200 electrical stimulators have been cleared for marketing since 1977. The output characteristics of conventional tDCS, tACS, and tPCS techniques are well below those of most FDA cleared devices, including devices that are available OTC and those intended for stimulation on the head. This engineering analysis demonstrates that with

Small Area Estimate Maps: Does the FDA Regulate Tobacco? - Small Area Estimates

Science.gov (United States)

This metric is defined as a person 18 years of age or older who must have reported that he/she believes that the United States Food and Drug Administration (FDA) regulates tobacco products in the U.S.

Changes in FDA enforcement activities following changes in federal administration: the case of regulatory letters released to pharmaceutical companies

Directory of Open Access Journals (Sweden)

Nguyen Diane

2013-01-01

Full Text Available Abstract Background The United States (US Food and Drug Administration (FDA is responsible for the protection of the public health by assuring the safety, effectiveness and security of human drugs and biological products through the enforcement of the Federal Food, Drug and Cosmetic Act (FDCA and related regulations. These enforcement activities include regulatory letters (i.e. warning letters and notice of violation to pharmaceutical companies. A regulatory letter represents the FDA’s first official notification to a pharmaceutical company that the FDA has discovered a product or activity in violation of the FDCA. This study analyzed trends in the pharmaceutical-related regulatory letters released by the FDA during the period 1997–2011 and assessed differences in the average number and type of regulatory letters released during the last four federal administrations. Methods Data derived from the FDA webpage. Information about the FDA office releasing the letter, date, company, and drug-related violation was collected. Regulatory letters were classified by federal administration. Descriptive statistics were performed for the analysis. Results Between 1997 and 2011 the FDA released 2,467 regulatory letters related to pharmaceuticals. FDA headquarters offices released 50.6% and district offices 49.4% of the regulatory letters. The Office of Prescription Drug Promotion released the largest number of regulatory letters (850; 34.5% of the total, followed by the Office of Scientific Investigations (131; 5.3%, and the Office of Compliance (105; 4.3%. During the 2nd Clinton Administration (1997–2000 the average number of regulatory letters per year was 242.8 ± 45.6, during the Bush Administration (2001–2008 it was 120.4 ± 33.7, and during the first three years of the Obama administration (2009–2011 it was 177.7.0 ± 17.0. The average number of regulatory letters released by the Office of Prescription Drug Promotion also varied by

Design of Multi-core Fiber Patch Panel for Space Division Multiplexing Implementations

DEFF Research Database (Denmark)

Gonzalez, Luz E.; Morales, Alvaro; Rommel, Simon

2018-01-01

A multi-core fiber (MCF) patch panel was designed, allowing easy coupling of individual signals to and from a 7-core MCF. The device was characterized, measuring insertion loss and cross talk, finding highest insertion loss and lowest crosstalk at 1300 nm with values of 9.7 dB and -36.5 d...

PERBANDINGAN UNJUK KERJA ANTARA PANEL SEL SURYA BERPENJEJAK DENGAN PANEL SEL SURYA DIAM

Directory of Open Access Journals (Sweden)

Syafaruddin Ch

2010-07-01

Full Text Available The ability to produce electrical energy at Solar Power Plant  is highly dependent on the magnitude and duration of sun exposure on the solar cell panels. The movement of the sun from east to west that periodicity in every day is a problem at  the  optimization generation of electricity at  Solar Power Plant   if using solar panel that motionless. This is because the solar cell panel can not catch the maximum sun exposure. To solve the above problem then designed a solar cell panel  tracker  capable of follo-wing the movements of the sun. Then conducted a test to see the performance of solar cell pa-nel  tracker  and compare it with the performance of solar cell panel was motionless. The testing doing along 6 days, with way to irradiate the panel of solar cells  tracker  and panels of solar cell motionless with sun exposure  along a  full day. Then the electric current generated each panel were recorded. The comparison of current then generating comparison of electric power delivery. The result show that the solar cell panel  tracker  produce the average current is 2.19 A whereas solar-cell panel still 1.97 A.  This result   indicate that average power for solar cell panel  tracker  39.41 W while for solar cell panel that motionless is  35.46 W. These results indicate that the performance of solar cell panel  tracker  better than  solar cell panel motionless.

Noise Reduction in Double‿Panel Structures by Cavity and Panel Resonance Control

OpenAIRE

Ho, J.; Berkhoff, Arthur P.

2011-01-01

This paper presents an investigation of the cavity and the panel resonance control in a double‿panel structure. The double‿panel structure, which consists of two panels with air in the gap, is widely adopted in many applications such as aerospace due to its light weight and effective transmission‿loss at high frequency. However, the resonance of the cavity and the poor transmission‿loss at low frequency limit its noise control performance. Applying active control forces on the panels or utili...

FDA Food Code recommendations: how do popular US baking shows measure up?

Directory of Open Access Journals (Sweden)

Valerie Cadorett

2018-05-01

Full Text Available The purpose of this study was to determine if popular US baking shows follow the FDA Food Code recommendations and critical food safety principles. This cross-sectional study examined a convenience sample of 75 episodes from three popular baking shows. The three shows were about competitively baking cupcakes, competitively baking cakes, and baking in a popular local bakery. Twenty-five episodes from each show were viewed. Coding involved tallying how many times 17 FDA Food Code recommendations were or were not followed. On each show, bare hands frequently came in contact with ready-to-eat food. On a per-hour basis, this occurred 80, 155, and 176 times on shows 1-3, respectively. Hands were washed before cooking three times on the three shows and never for the recommended 20 seconds. On each show, many people touched food while wearing jewelry other than a plain wedding band, for an average of at least 7 people per hour on each show. Shows 1-3 had high rates of long-haired bakers not wearing hair restraints (11.14, 6.57, and 14.06 per hour, respectively. Shows 1 and 2 had high rates of running among the bakers (22.29 and 10.57 instances per hour, respectively. These popular baking shows do not demonstrate proper food safety techniques put forth by the FDA and do not contribute the reduction of foodborne illnesses through proper food handling.

FDA approves efavirenz. Food and Drug Administration.

Science.gov (United States)

Highleyman, L

1998-10-01

The Food and Drug Administration (FDA) approved DuPont Pharma's new non-nucleoside reverse transcriptase inhibitor (NNRTI) efavirenz (Sustiva, DMP-266). Efavirenz has shown promise in trials with over 2000 participants for up to 24 weeks, and early data suggests it may be as effective as protease inhibitors when used in a combination regimen. It is the first anti-HIV drug approved for once-daily dosing. Efavirenz is well tolerated, and the main side effects reported are dizziness, insomnia, abnormal dreams, and skin rash. Efavirenz has been approved for adults and children, but should not be used by pregnant women. Contact information is provided.

Synthesis and characterization of a microporous 6FDA-polyimide made from a novel carbocyclic pseudo Tröger's base diamine: Effect of bicyclic bridge on gas transport properties

KAUST Repository

Abdulhamid, Mahmoud A.

2017-10-12

A newly designed carbocyclic pseudo Tröger\\'s base diamine (CTB) monomer, 2,8-dimethyl-3,9-diamino-5,6,11,12-tetrahydro-5,11-methanodibenzo[a,e][8]annulene (CTBDA) and its isomeric analogue 2,8-dimethyl-(1,7)(4,10)(3,9)-diamino-5,6,11,12-tetrahydro-5,11-methanodibenzo[a,e][8]annulene (iCTBDA), were designed for the synthesis of microporous 6FDA-based polyimides (6FDA-CTBDA and 6FDA-iCTBDA). Both polyimides were soluble, exhibited excellent thermal stability of ∼490 °C, and had high surface areas of 587 m2 g−1 (6FDA-CTBDA) and 562 m2 g−1 (6FDA-iCTBDA). A 6FDA-based polyimide derived from 4,10-dimethyl-3,9-diamino-6H,12H-5,11-methanodibenzo[b,f][1,5]-diazocine (6FDA-TBDA) was made for comparison to investigate the effects of the basic tertiary nitrogen functionality in the Tröger\\'s base diamine on the polymer properties relative to the carbocyclic 6FDA-CTBDA analogue. 6FDA-TBDA displayed lower gas permeabilities but moderately higher gas-pair permselectivities than 6FDA-CTBDA. The enhanced permselectivity of 6FDA-TBDA resulted exclusively from higher diffusion-based selectivity. Direct gas sorption measurements demonstrated that the basicity in the Tröger\\'s base bridge moiety enhanced the sorption capacity of CO2 only slightly and had no effect on the CO2/CH4 solubility selectivity in 6FDA-TBDA vs. 6FDA-CTBDA.

Year 2000 (Y2K) computer compliance guide; guidance for FDA personnel. Food and Drug Administration. Notice.

Science.gov (United States)

1999-05-14

The Food and Drug Administration (FDA) is announcing the availability of a new compliance policy guide (CPG) entitled "Year 2000 (Y2K) Computer Compliance" (section 160-800). This guidance document represents the agency's current thinking on the manufacturing and distribution of domestic and imported products regulated by FDA using computer systems that may not perform properly before, or during, the transition to the year 2000 (Y2K). The text of the CPG is included in this notice. This compliance guidance document is an update to the Compliance Policy Guides Manual (August 1996 edition). It is a new CPG, and it will be included in the next printing of the Compliance Policy Guides Manual. This CPG is intended for FDA personnel, and it is available electronically to the public.

Estimation of Viable Biomass In Wastewater And Activated Sludge By Determination of ATP, Oxygen Utilization Rate And FDA Hydrolysis

DEFF Research Database (Denmark)

Jørgensen, Poul-Erik; Eriksen, T.; Jensen, B.K.

1992-01-01

ATP content, oxygen utilization rate (OUR) and fluorescein diacetate (FDA) hydrolysis were tested for the ability to express the amount of viable biomass in wastewater and activated sludge. The relationship between biomass and these activity parameters was established in growth cultures made...... with biomass, while FDA hydrolysis in the sludge failed to show any such correlation. Conversion factors of 3 mg ATP/g dw, 300 mg O2/h g dw and 0.4 A/h (mg dw/ml) for ATP, OUR and FDA methods, respectively, were calculated. When the methods were applied for in situ determinations in four different wastewater...... plants, it was found that ATP content and respiration rate estimated viable biomass to range from 81 to 293 mg dw/g SS for raw wastewater and from 67 to 187 mg dw/g SS for activated sludge with a rather weak correlation between ATP and respiration measurements. The FDA hydrolysis estimated viable biomass...

FDA Accelerates Testing and Review of Experimental Brain Cancer Drug | FNLCR Staging

Science.gov (United States)

An investigational brain cancer drug made with disabled polio virus and manufactured at the Frederick National Lab has won breakthrough status from the Food and Drug Administration (FDA) to fast-track its further refinement and clinical testing.  Br

The FDA's decision-making process: isn't it time to temper the principle of protective paternalism?

Science.gov (United States)

Brandt, Lawrence J

2008-05-01

The authors conducted a well-designed, multinational, large study of women younger than 65 yr of age with irritable bowel syndrome (IBS) with a mixed pattern of diarrhea and constipation (IBS-M) or constipation (IBS-C) and showed that a statistically greater percentage of patients in each group responded to tegaserod compared with patients treated with placebo. Practicality looms large, however, in that the Food and Drug Administration (FDA) disallowed the continued marketing of tegaserod because of cardiovascular safety concerns, and it now is only available under a restricted access program. The wisdom of this decision aside, it is disturbing that the FDA revealed a zero-tolerance for any significant risk of disease when a drug (e.g., tegaserod) was used for a nonlife-threatening condition; the FDA chose to neglect any potential benefit of significant improvement in quality of life, while at the same time allowing the continued availability of sildenifil for erectile dysfunction and other medications (e.g., rosiglitazone and nonsteroidal anti-inflammatory drugs [NSAIDs]), each with a far greater risk of cardiovascular complications. Whether tegaserod will be re-released and, if so, under what conditions, is yet to be determined, as is the question of whether the FDA will decide to allow a more transparent decision-making process with input from all interested parties affected by their decision.

78 FR 25747 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of...

Science.gov (United States)

2013-05-02

... Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD... as catheters, cannulae or hollow needles. Chronic hemodialysis catheters are soft, blunt-tipped...

Paneling architectural freeform surfaces

KAUST Repository

Eigensatz, Michael

2010-07-25

The emergence of large-scale freeform shapes in architecture poses big challenges to the fabrication of such structures. A key problem is the approximation of the design surface by a union of patches, so-called panels, that can be manufactured with a selected technology at reasonable cost, while meeting the design intent and achieving the desired aesthetic quality of panel layout and surface smoothness. The production of curved panels is mostly based on molds. Since the cost of mold fabrication often dominates the panel cost, there is strong incentive to use the same mold for multiple panels. We cast the major practical requirements for architectural surface paneling, including mold reuse, into a global optimization framework that interleaves discrete and continuous optimization steps to minimize production cost while meeting user-specified quality constraints. The search space for optimization is mainly generated through controlled deviation from the design surface and tolerances on positional and normal continuity between neighboring panels. A novel 6-dimensional metric space allows us to quickly compute approximate inter-panel distances, which dramatically improves the performance of the optimization and enables the handling of complex arrangements with thousands of panels. The practical relevance of our system is demonstrated by paneling solutions for real, cutting-edge architectural freeform design projects.

Paneling architectural freeform surfaces

KAUST Repository

Eigensatz, Michael

2010-07-26

The emergence of large-scale freeform shapes in architecture poses big challenges to the fabrication of such structures. A key problem is the approximation of the design surface by a union of patches, socalled panels, that can be manufactured with a selected technology at reasonable cost, while meeting the design intent and achieving the desired aesthetic quality of panel layout and surface smoothness. The production of curved panels is mostly based on molds. Since the cost of mold fabrication often dominates the panel cost, there is strong incentive to use the same mold for multiple panels. We cast the major practical requirements for architectural surface paneling, including mold reuse, into a global optimization framework that interleaves discrete and continuous optimization steps to minimize production cost while meeting user-specified quality constraints. The search space for optimization is mainly generated through controlled deviation from the design surface and tolerances on positional and normal continuity between neighboring panels. A novel 6-dimensional metric space allows us to quickly compute approximate inter-panel distances, which dramatically improves the performance of the optimization and enables the handling of complex arrangements with thousands of panels. The practical relevance of our system is demonstrated by paneling solutions for real, cutting-edge architectural freeform design projects. © 2010 ACM.

Design of multi-core fiber patch panel for space division multiplexing implementations

NARCIS (Netherlands)

González, Luz E.; Morales, Alvaro; Rommel, Simon; Jørgensen, Bo F.; Porras-Montenegro, N.; Tafur Monroy, Idelfonso

2018-01-01

A multi-core fiber (MCF) patch panel was designed, allowing easy coupling of individual signals to and from a 7-core MCF. The device was characterized, measuring insertion loss and cross talk, finding highest insertion loss and lowest crosstalk at 1300 nm with values of 9.7 dB and -36.5 dB

Solarbus Solar Array Innovative Light Weight Mechanical Architecture with Thin Lateral Panels Deployed with Shape Memory Alloy Regulator

Science.gov (United States)

D'Abrigeon, Laurent; Carpine, Anne; Laduree, Gregory

2005-05-01

The standard ALCATEL SOLAR ARRAY PLANAR CONCEPT on the TELECOM market today on flight is named SOLARBUS.This concept is:• 3 to 10 identical panels covered with Si Hi-η celltechnology.• A central mast constitute by 3 to 4 panels and 1yoke linked together by hinges and synchronizedby cables.• From 2 to 6 lateral panelsThis concept is able to fit with the customer requirements in order to have a competitive "global offer at system level" (mass to power ratio 48-50 W/Kg)But, for the near future, in line with the market trend, and based on the previous experience, an improvement of the SOLARBUS Solar Array concept in term of W/kg/€ is essential in order to maintain the competitiveness of the global ALCATEL offer at system level.In order to increase the W/Kg performance Alcatel has developed a new architecture named Lightweight Panel Structure (LPS). The objectives of this new structure are :• To decrease the kg/m2 ratio • To be compatible of all promising cells technology including Si Hi-n, GaAs, GaAs+ small reflectors. This new architecture is based on the fact that during the 3 major life phases of a Solar Array (Launch/Deployment/Deployed orbital life), the structural needs are more important for the central panels than for the lateral panels.So two different panels have been designed :• Central panels (named LPS1)• Lateral panels (named LPS2)The stowing configuration as been adapted : 2 thin lateral panels LPS2 between 2 structural central panels LPS1, and local bumpers to transfer the loads from LPS2 to LPS1.Also one of the more stringent loads applied to the panels are corresponding to deployment loads. In order to limit the mass of reinforcement of the panels, a deployment speed regulator shall be used. In the frame of the new generation of solar arrays, Alcatel has developed a new actuator based on shape memory alloy torsional rod. This light weight component is directly connected to heaters lines and is able to provide great actuation torque

Panel 5: Microbiology and Immunology Panel

Science.gov (United States)

Murphy, Timothy F.; Chonmaitree, Tasnee; Barenkamp, Stephen; Kyd, Jennelle; Nokso-Koivisto, Johanna; Patel, Janak A.; Heikkinen, Terho; Yamanaka, Noboru; Ogra, Pearay; Swords, W. Edward; Sih, Tania; Pettigrew, Melinda M.

2014-01-01

Objective The objective is to perform a comprehensive review of the literature from January 2007 through June 2011 on the virology, bacteriology, and immunology related to otitis media. Data Sources PubMed database of the National Library of Medicine. Review Methods Three subpanels with co-chairs comprising experts in the virology, bacteriology, and immunology of otitis media were formed. Each of the panels reviewed the literature in their respective fields and wrote draft reviews. The reviews were shared with all panel members, and a second draft was created. The entire panel met at the 10th International Symposium on Recent Advances in Otitis Media in June 2011 and discussed the review and refined the content further. A final draft was created, circulated, and approved by the panel. Conclusion Excellent progress has been made in the past 4 years in advancing an understanding of the microbiology and immunology of otitis media. Advances include laboratory-based basic studies, cell-based assays, work in animal models, and clinical studies. Implications for Practice The advances of the past 4 years formed the basis of a series of short-term and long-term research goals in an effort to guide the field. Accomplishing these goals will provide opportunities for the development of novel interventions, including new ways to better treat and prevent otitis media. PMID:23536533

Current and future state of FDA-CMS parallel reviews.

Science.gov (United States)

Messner, D A; Tunis, S R

2012-03-01

The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) recently proposed a partial alignment of their respective review processes for new medical products. The proposed "parallel review" not only offers an opportunity for some products to reach the market with Medicare coverage more quickly but may also create new incentives for product developers to conduct studies designed to address simultaneously the information needs of regulators, payers, patients, and clinicians.

Comparisons between various cavity and panel noise reduction control in double-panel structures

NARCIS (Netherlands)

Ho, J.H.; Kalverboer, J.; Berkhoff, A.P.

2012-01-01

This paper presents comparisons between various panel and cavity resonance control methods to reduce the transmitted sound in a double-panel structure. The double-panel, which consists of two panels with air in the gap, has the advantages of low weight and effective transmission-loss at high

Language and Nutrition (Mis)Information: Food Labels, FDA Policies and Meaning

Science.gov (United States)

Taylor, Christy Marie

2013-01-01

In this dissertation, I address the ways in which food manufacturers can exploit the often vague and ambiguous nature of FDA policies concerning language and images used on food labels. Employing qualitative analysis methods (Strauss, 1987; Denzin and Lincoln, 2003; Mackey and Gass, 2005) that drew upon critical discourse analysis (Fairclough,…

21 CFR 14.15 - Committees working under a contract with FDA.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Committees working under a contract with FDA. 14.15 Section 14.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... committee: (1) The committee shall give public notice of its meetings and agenda, and provide interested...

FDA Approves Immunotherapy for a Cancer that Affects Infants and Children | FNLCR

Science.gov (United States)

The U.S. Food and Drug Administration (FDA) has approved dinutuximab (ch14.18) as an immunotherapy for neuroblastoma, a rare type of childhood cancer that offers poor prognosis for about half of the children who are affected.  The National Cancer In

The rosiglitazone decision process at FDA and EMA : What should we learn?

NARCIS (Netherlands)

Pouwels, Koen B.; van Grootheest, Kees

2012-01-01

In September 2010 the EMA decided to suspend the market authorisation of rosiglitazone, while the FDA decided to restrict the use of rosiglitazone. These actions were taken approximately 10 years after the introduction of rosiglitazone, because rosiglitazone might be associated with an increased

Level of Evidence Associated with FDA Safety Communications with Drug Labeling Changes: 2010-2014

Directory of Open Access Journals (Sweden)

Benjamin Hixon

2017-02-01

Full Text Available Purpose: Approximately 800,000 safety reports are submitted to the FDA annually, however, only significant issues generate drug safety communications (DSC. The purpose of this study was to determine the type of clinical evidence used to warrant a change in drug labeling for drugs with DSC between January 1, 2010 and December 31, 2014. Methods: Selected data was obtained from the FDA website. The primary endpoint of the study was the frequency of the types of clinical evidence used in FDA communications, as reported through the FDA DSC. Results were evaluated via descriptive statistics, and chi-squared for nominal data. Results: A total of 2521 drug safety labeling changes were identified and 99 (3.9% of safety communications met the inclusion criteria. The majority of the labeling changes were associated with single agents (83.8%. The three most frequently reported labeling changes were warnings (68.7%, precautions (58.6%, and patient package insert/medication guide (23.2%. Case reports resulted in the greatest number of documented literature types (n = 791, followed by randomized controlled trials (n = 76, and case control/cohort studies (n = 74. Significantly more evidence for DSCs were classified as Level of Evidence B (LOE B, 68.6%, compared to LOE A (17.1%, and LOE C (14.1% (p = 0.007. Conclusions: The majority of drug labeling change initiators was associated with LOE equivalent to B. Practitioners should evaluate data associated with labeling changes to determine how to interpret the information for their patients. Conflict of Interest We declare no conflicts of interest or financial interests that the authors or members of their immediate families have in any product or service discussed in the manuscript, including grants (pending or received, employment, gifts, stock holdings or options, honoraria, consultancies, expert testimony, patents and royalties.   Type: Original Research

Compact flat-panel gas-gap heat switch operating at 295 K

Science.gov (United States)

Krielaart, M. A. R.; Vermeer, C. H.; Vanapalli, S.

2015-11-01

Heat switches are devices that can change from a thermally conducting (on-) state to an insulating (off-) state whenever the need arises. They enable adaptive thermal management strategies in which cooling rates are altered either spatially or temporally, leading to a substantial reduction in the energy and mass budget of a large range of systems. State-of-the-art heat switches are only rarely employed in thermal system architectures, since they are rather bulky and have a limited thermal performance (expressed as the heat transfer ratio between the on- and off-state heat conductance). Using selective laser melting additive manufacturing technology, also known as 3D printing, we developed a compact flat-panel gas-gap heat switch that offers superior thermal performance, is simpler and more economic to produce and assemble, contains no moving parts, and is more reliable because it lacks welded joints. The manufactured rectangular panel heat switch has frontal device dimensions of 10 cm by 10 cm, thickness of 3.2 mm and weighs just 121 g. An off heat conductance of 0.2 W/K and on-off heat conductance ratio of 38 is observed at 295 K.

A common feature pharmacophore for FDA-approved drugs inhibiting the Ebola virus.

Science.gov (United States)

Ekins, Sean; Freundlich, Joel S; Coffee, Megan

2014-01-01

We are currently faced with a global infectious disease crisis which has been anticipated for decades. While many promising biotherapeutics are being tested, the search for a small molecule has yet to deliver an approved drug or therapeutic for the Ebola or similar filoviruses that cause haemorrhagic fever. Two recent high throughput screens published in 2013 did however identify several hits that progressed to animal studies that are FDA approved drugs used for other indications. The current computational analysis uses these molecules from two different structural classes to construct a common features pharmacophore. This ligand-based pharmacophore implicates a possible common target or mechanism that could be further explored. A recent structure based design project yielded nine co-crystal structures of pyrrolidinone inhibitors bound to the viral protein 35 (VP35). When receptor-ligand pharmacophores based on the analogs of these molecules and the protein structures were constructed, the molecular features partially overlapped with the common features of solely ligand-based pharmacophore models based on FDA approved drugs. These previously identified FDA approved drugs with activity against Ebola were therefore docked into this protein. The antimalarials chloroquine and amodiaquine docked favorably in VP35. We propose that these drugs identified to date as inhibitors of the Ebola virus may be targeting VP35. These computational models may provide preliminary insights into the molecular features that are responsible for their activity against Ebola virus in vitro and in vivo and we propose that this hypothesis could be readily tested.

A Comprehensive Review of US FDA-Approved Immune Checkpoint Inhibitors in Urothelial Carcinoma

Directory of Open Access Journals (Sweden)

Fu-Shun Hsu

2017-01-01

Full Text Available Few effective treatment options are available for patients with advanced or metastatic urothelial carcinoma (UC after unsuccessful first-line platinum-based chemotherapy. To date, immune checkpoint inhibitors are novel therapeutic agents for UC treatment. From May 2016 to May 2017, five anti-PD-1/PD-L1 monoclonal antibodies received accelerated or regular approval from the US Food and Drug Administration (FDA for the treatment of patients with locally advanced or metastatic UC. The present comprehensive review presents the background information of these five US FDA-approved anticancer agents to provide a basic but concise understanding of these agents for advanced studies. We summarize their immune checkpoint mechanisms, clinical efficacy, recommended usage protocols, adverse events, and the limitations of the PD-L1 biomarker assays.

Achievement report for fiscal 1981 on the development of solar energy technologies for the development of practical application technologies for photovoltaic power systems. Experimental fabrication of solar cell panels and verification thereof (Development of technologies for panel assembly process); 1981 nendo taiyo energy gijutsu kenkyu kaihatsu seika hokokusho (taiyoko hatsuden system jitsuyoka gijutsu kaihatsu). Taiyo denchi panel jikken seisaku kensho (panel kumitate kotei no gijutsu kaihatsu)

Energy Technology Data Exchange (ETDEWEB)

NONE

1982-03-01

In a study of cell array connection process, continuous and automatic connection of cells is named as the basic concept in view of low cost and high reliability. In the designing of details of cell strings, CZ (Czochralski) cell dimensions are reviewed for cell packaging efficiency improvement, interconnectors and wiring are examined for a easier packaging process, and solder connection is thought over for utility cost reduction. Conditions are established for string fabrication process details. In the study of the panel packaging process, panel package designing is carried out and a dedicated mechanical device is installed. In the study of the inspection process and plant system, data are collected, necessary for the construction and adjustment of an inspection device. Research is conducted on the layout of plant facilities, on required utilities, and on facilities operating state signals to be transmitted to the central control unit. As for an inspection jig supply system, transfer system, and storage rack, they are designed, built, and installed. The plant house is now complete. (NEDO)

Solar reflection panels

Science.gov (United States)

Diver, Jr., Richard B.; Grossman, James W [Albuquerque, NM; Reshetnik, Michael [Boulder, CO

2006-07-18

A solar collector comprising a glass mirror, and a composite panel, wherein the back of the mirror is affixed to a front surface of the composite panel. The composite panel comprises a front sheet affixed to a surface of a core material, preferably a core material comprising a honeycomb structure, and a back sheet affixed to an opposite surface of the core material. The invention may further comprise a sealing strip, preferably comprising EPDM, positioned between the glass mirror and the front surface of the composite panel. The invention also is of methods of making such solar collectors.

Schedules of Controlled Substances: Placement of FDA-Approved Products of Oral Solutions Containing Dronabinol [(-)-delta-9-trans-

Science.gov (United States)

2017-11-22

This final rule adopts without changes an interim final rule with request for comments published in the Federal Register on March 23, 2017. On July 1, 2016, the U.S. Food and Drug Administration (FDA) approved a new drug application for Syndros, a drug product consisting of dronabinol [(-)-delta-9-trans-tetrahydrocannabinol (delta-9-THC)] oral solution. The Drug Enforcement Administration (DEA) maintains FDA-approved products of oral solutions containing dronabinol in schedule II of the Controlled Substances Act.

Design and construction of program frame software of 300 keV/20 mA EBM control panel computerized base

International Nuclear Information System (INIS)

Eko Priyono; Saminto

2015-01-01

The program frame software of computer based control panel for 300 keV/20 mA EBM has been designed and constructed. This software is used for EBM components operating system, EBM operating parameters monitor and control system. This software contain instructions program for acquisition, actuation, process and display operation parameters data which is made by using visual basic V.6. This software displays some menus i.e. cover menu, main menu, sub menu and sub-sub menu. Performance test was done by integrating software and hardware and then operated the EBM via computer device. The test show that data communication between software and hardware was suitable, EBM components can be operated via computer device, EMB operation parameters can be controlled and monitored in form digital number, bar graph and continuous graphics the device can execute properly all instruction output program of 300 keV/20 mA control panel so the device is ready to use as one of computerize operating system of 300 keV/20 mA. (author)

Proficiency testing for sensory profile panels : measuring panel performance

NARCIS (Netherlands)

Mcewan, J.A.; Hunter, E.A.; Gemert, L.J. van; Lea, P.

2002-01-01

Proficiency testing in sensory analysis is an important step towards demonstrating that results from one sensory panel are consistent with the results of other sensory panels. The uniqueness of sensory analysis poses some specific problems for measuring the proficiency of the human instrument

Large thermal protection system panel

Science.gov (United States)

Weinberg, David J. (Inventor); Myers, Franklin K. (Inventor); Tran, Tu T. (Inventor)

2003-01-01

A protective panel for a reusable launch vehicle provides enhanced moisture protection, simplified maintenance, and increased temperature resistance. The protective panel includes an outer ceramic matrix composite (CMC) panel, and an insulative bag assembly coupled to the outer CMC panel for isolating the launch vehicle from elevated temperatures and moisture. A standoff attachment system attaches the outer CMC panel and the bag assembly to the primary structure of the launch vehicle. The insulative bag assembly includes a foil bag having a first opening shrink fitted to the outer CMC panel such that the first opening and the outer CMC panel form a water tight seal at temperatures below a desired temperature threshold. Fibrous insulation is contained within the foil bag for protecting the launch vehicle from elevated temperatures. The insulative bag assembly further includes a back panel coupled to a second opening of the foil bag such that the fibrous insulation is encapsulated by the back panel, the foil bag, and the outer CMC panel. The use of a CMC material for the outer panel in conjunction with the insulative bag assembly eliminates the need for waterproofing processes, and ultimately allows for more efficient reentry profiles.

Thermal energy storage in the form of heat or cold with using of the PCM-based accumulation panels

Directory of Open Access Journals (Sweden)

Skovajsa Jan

2016-01-01

Full Text Available This article describes the usage of thermal energy storage in the form of heat and cold with an adaptation of the special device which is composed of the thermal panels. These panels are based on the phase change materials (PCM for normal inner environment temperature in buildings. The energy for the thermal energy storage is possible to get from built-in electric heating foil or from the tube heat exchanger, which is build in the thermal panels. This technology is able to use renewable energy sources, for example, solar thermal collectors and air-to-water heat pump as a source of heat for heating of the hot water tank. In the cooling mode, there is able to use the heat pump or photovoltaics panels in combination with thermoelectric coolers for cooling.

Mechanical testing of a FW panel attachment system for ITER

International Nuclear Information System (INIS)

Oliva, Vladislav; Vaclavik, Jaroslav; Materna, Ales; Lorenzetto, Patrick; Furmanek, Andreas

2009-01-01

An objective of experiments and finite element simulations was to check the stiffness, the strength and the fatigue resistance of the attachment of the First Wall panels onto a shield block of blanket modules according to the ITER 2001 design. The panel has a poloidal key at the rear side (in so-called option A with the rear access bolting) and it is attached by means of special studs located on a key-way in the shield block. Special device for a test of stud tensile pre-load relaxation during a thermal cycling was developed. True-to-scale panels, the shield block mock-up and simplified studs were fabricated and the assembly was loaded alternatively by radial moment, poloidal force or poloidal moment simulating the loading during off-normal plasma operations. Thermal cycling led to an acceptable stud pre-load relaxation. Mechanical cycling caused neither the pre-load relaxation nor the loss of the contact in the key-way nor a damage of the attachment system. The combination of poloidal moment and radial force during vertical displacement events (VDEs) seems to be a most dangerous case because it could lead to the loss of the key-key-way contact.

Chloroquine, a FDA-approved Drug, Prevents Zika Virus Infection and its Associated Congenital Microcephaly in Mice.

Science.gov (United States)

Li, Chunfeng; Zhu, Xingliang; Ji, Xue; Quanquin, Natalie; Deng, Yong-Qiang; Tian, Min; Aliyari, Roghiyh; Zuo, Xiangyang; Yuan, Ling; Afridi, Shabbir Khan; Li, Xiao-Feng; Jung, Jae U; Nielsen-Saines, Karin; Qin, Frank Xiao-Feng; Qin, Cheng-Feng; Xu, Zhiheng; Cheng, Genhong

2017-10-01

Zika virus (ZIKV) has become a global public health emergency due to its rapidly expanding range and its ability to cause severe congenital defects such as microcephaly. However, there are no FDA-approved therapies or vaccines against ZIKV infection. Through our screening of viral entry inhibitors, we found that chloroquine (CQ), a commonly used antimalarial and a FDA-approved drug that has also been repurposed against other pathogens, could significantly inhibit ZIKV infection in vitro, by blocking virus internalization. We also demonstrated that CQ attenuates ZIKV-associated morbidity and mortality in mice. Finally, we proved that CQ protects fetal mice from microcephaly caused by ZIKV infection. Our methodology of focusing on previously identified antivirals in screens for effectiveness against ZIKV proved to be a rapid and efficient means of discovering new ZIKV therapeutics. Selecting drugs that were previously FDA-approved, such as CQ, also improves the likelihood that they may more quickly reach stages of clinical testing and use by the public. Copyright © 2017. Published by Elsevier B.V.

Puncture panel optimization

International Nuclear Information System (INIS)

Glass, R.E.; Longenbaugh, R.S.

1986-01-01

Sandia National Laboratories developed the TRansUranic PACkage Transporter (TRUPACT) to transport defense contact-handled transuranic wastes. The package has been designed to meet the normal and hypothetical accident conditions in 10CFR71 which includes the demonstrated ability to survive a 1-meter drop onto a mild steel pin. The puncture protection is provided by puncture resistant panels. In conjunction with the development of TRUPACT, a series of experiments has been conducted to reduce the weight of the puncture resistant panels. The initial scoping tests resulted in a preliminary design incorporating 30 layers of Kevlar. This design has been shown to meet the regulatory puncture test. To reduce the weight of this panel, subscale tests were conducted on panels utilizing Kevlar yarns with varying mass per unit length (denier) as well as different resins. This paper reviews the testing undertaken in the original panel development and discusses the results obtained from the recent subscale and full-scale optimization tests

Cavity Control and Panel Control Strategies in Double-Panel Structures for Transmitted Noise Reduction

NARCIS (Netherlands)

Ho, J.; Kalverboer, J.; Berkhoff, Arthur P.

2012-01-01

Investigation and comparisons of the cavity control and the panel control in a double-panel structure are presented in this paper. The double-panel structure, which comprises two panels with air in the gap, provides the advantages of low sound-transmission at high frequency, low heat-transmission

21 CFR 111.610 - What records must be made available to FDA?

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What records must be made available to FDA? 111.610 Section 111.610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING...

Hepatic (Liver) Function Panel

Science.gov (United States)

... Educators Search English Español Blood Test: Hepatic (Liver) Function Panel KidsHealth / For Parents / Blood Test: Hepatic (Liver) ... kidneys ) is working. What Is a Hepatic (Liver) Function Panel? A liver function panel is a blood ...

Stem-cell-derived products: an FDA update.

Science.gov (United States)

Moos, Malcolm

2008-12-01

The therapeutic potential of products derived from stem cells of various types has prompted increasing research and development and public attention. Initiation of human clinical trials in the not-too-distant future is now a realistic possibility. It is, therefore, important to weigh the potential benefits against known, theoretical and totally unsuspected risks in light of current knowledge to ensure that subjects participating in these trials are afforded the most reasonable balance possible between potential risks and potential benefits. There are no apparent differences in fundamental, qualitative biological characteristics between stem-cell-derived products and other cellular therapies regulated by the United States Food and Drug Administration (FDA). Existing authorities can, therefore, be applied. Nevertheless, these products do have properties that require careful evaluation.

Panel Resonance Control and Cavity Control in Double-Panel Structures for Active Noise Reduction

NARCIS (Netherlands)

Ho, J.; Berkhoff, Arthur P.

2011-01-01

An analytical and experimental investigation of panel resonance control and cavity control in a double-panel structure is presented in this paper. The double-panel structure, which consists of two panels with air in the gap, is widely adopted in many applications such as aerospace due to its low

FDA toxicity databases and real-time data entry

International Nuclear Information System (INIS)

Arvidson, Kirk B.

2008-01-01

Structure-searchable electronic databases are valuable new tools that are assisting the FDA in its mission to promptly and efficiently review incoming submissions for regulatory approval of new food additives and food contact substances. The Center for Food Safety and Applied Nutrition's Office of Food Additive Safety (CFSAN/OFAS), in collaboration with Leadscope, Inc., is consolidating genetic toxicity data submitted in food additive petitions from the 1960s to the present day. The Center for Drug Evaluation and Research, Office of Pharmaceutical Science's Informatics and Computational Safety Analysis Staff (CDER/OPS/ICSAS) is separately gathering similar information from their submissions. Presently, these data are distributed in various locations such as paper files, microfiche, and non-standardized toxicology memoranda. The organization of the data into a consistent, searchable format will reduce paperwork, expedite the toxicology review process, and provide valuable information to industry that is currently available only to the FDA. Furthermore, by combining chemical structures with genetic toxicity information, biologically active moieties can be identified and used to develop quantitative structure-activity relationship (QSAR) modeling and testing guidelines. Additionally, chemicals devoid of toxicity data can be compared to known structures, allowing for improved safety review through the identification and analysis of structural analogs. Four database frameworks have been created: bacterial mutagenesis, in vitro chromosome aberration, in vitro mammalian mutagenesis, and in vivo micronucleus. Controlled vocabularies for these databases have been established. The four separate genetic toxicity databases are compiled into a single, structurally-searchable database for easy accessibility of the toxicity information. Beyond the genetic toxicity databases described here, additional databases for subchronic, chronic, and teratogenicity studies have been prepared

Automatic extraction of drug indications from FDA drug labels.

Science.gov (United States)

Khare, Ritu; Wei, Chih-Hsuan; Lu, Zhiyong

2014-01-01

Extracting computable indications, i.e. drug-disease treatment relationships, from narrative drug resources is the key for building a gold standard drug indication repository. The two steps to the extraction problem are disease named-entity recognition (NER) to identify disease mentions from a free-text description and disease classification to distinguish indications from other disease mentions in the description. While there exist many tools for disease NER, disease classification is mostly achieved through human annotations. For example, we recently resorted to human annotations to prepare a corpus, LabeledIn, capturing structured indications from the drug labels submitted to FDA by pharmaceutical companies. In this study, we present an automatic end-to-end framework to extract structured and normalized indications from FDA drug labels. In addition to automatic disease NER, a key component of our framework is a machine learning method that is trained on the LabeledIn corpus to classify the NER-computed disease mentions as "indication vs. non-indication." Through experiments with 500 drug labels, our end-to-end system delivered 86.3% F1-measure in drug indication extraction, with 17% improvement over baseline. Further analysis shows that the indication classifier delivers a performance comparable to human experts and that the remaining errors are mostly due to disease NER (more than 50%). Given its performance, we conclude that our end-to-end approach has the potential to significantly reduce human annotation costs.

A multi-panel direction-sensitive gamma-ray detector for low-altitude radiological searches

Energy Technology Data Exchange (ETDEWEB)

Becker, E.M.; Farsoni, A.T.

2016-11-11

A lightweight, low-cost multi-panel direction-sensitive radiation detector prototype has been developed at Oregon State University that is designed to be mounted on a small unmanned aerial system to autonomously search for radiation sources while flying close to the ground. The detection system comprises sixteen BGO-SiPM detector panels with an adjustable view angle, and signal outputs are processed in parallel in an FPGA. The minimum detectable activity was calculated to be 1.3 μCi of {sup 137}Cs at 1 m in under 60 s. The counting response of the detector panels were characterized and found to have 4.7% relative standard deviation, indicating good uniformity in overall design and assembly. The detector was also able to estimate the direction of a 12.3 μCi {sup 137}Cs source 100 cm from the device center with 2.3° accuracy in a 95% confidence width of 10.8° in 60 s.

FDA regulations regarding iodine addition to foods and labeling of foods containing added iodine12

Science.gov (United States)

Trumbo, Paula R

2016-01-01

The US Food and Drug Administration (FDA) regulates the addition of iodine to infant formulas, the iodization of salt, and the addition of salt and iodine to foods. The required amount of iodine in infant formulas is based on caloric content, and the label must provide the iodine content per 100 kcal. Cuprous iodide and potassium iodide may be added to table salt as a source of dietary iodine at a maximum amount of 0.01%; if added, the label must indicate that the salt is iodized. Table salt to which iodine has not been added must bear the statement, “This salt does not supply iodide, a necessary nutrient.” If a nutrient is to be appropriately added to a food for the purpose of correcting a dietary insufficiency, there should be sufficient scientific information available to demonstrate a nutritional deficiency and/or identify a public health problem. Furthermore, the population groups that would benefit from the proposed fortification should be identified. If iodine is added to a food, the percent Daily Value of iodine must be listed. There are no FDA regulations governing ingredient standards for dietary supplements. As a result, some dietary supplements include iodine and others do not. If a supplement contains iodine, the Supplement Facts label must list iodine as a nutrient ingredient. If iodine is not listed on the Supplement Facts label, then it has not been added. There are similarities between the FDA, which establishes US food regulations and policies, and the Codex Alimentarius (Codex), which develops international food standards and guidelines under the aegis of the FAO and the WHO. Both the FDA and Codex call for the labeling of table salt to indicate fortification with iodine, voluntary labeling of iodine on foods, and a Daily Value (called a Nutrient Reference Value by Codex) of 150 μg for iodine. PMID:27534626

FDA Approves Immunotherapy for a Cancer that Affects Infants and Children | FNLCR Staging

Science.gov (United States)

The U.S. Food and Drug Administration (FDA) has approved dinutuximab (ch14.18) as an immunotherapy for neuroblastoma, a rare type of childhood cancer that offers poor prognosis for about half of the children who are affected.  The National Cancer In

Abbreviations for device names: a proposed methodology with specific examples.

Science.gov (United States)

Alam, Murad; Dover, Jeffrey S; Alam, Murad; Goldman, Mitchel P; Kaminer, Michael S; Orringer, Jeffrey; Waldorf, Heidi; Alam, Murad; Avram, Mathew; Cohen, Joel L; Draelos, Zoe Diana; Dover, Jeffrey S; Hruza, George; Kilmer, Suzanne; Lawrence, Naomi; Lupo, Mary; Metelitsa, Andrei; Nestor, Mark; Ross, E Victor

2013-04-01

Many devices used in dermatology lack generic names. If investigators use commercial device names, they risk the appearance of bias. Alternatively, reliance on ad-hoc names and abbreviations may confuse readers who do not recognize these. To develop a system for assigning abbreviations to denote devices commonly used in dermatology. Secondarily, to use this system to create abbreviations for FDA-approved neurotoxins and prepackaged injectable soft-tissue augmentation materials. The American Society for Dermatologic Surgery convened a Lexicon Task Force in March 2012. One charge of this Task Force was to develop criteria for assigning abbreviations to medical devices. A modified consensus process was used. Abbreviations to denote devices were to be: based on a standardized approach; transparent to the casual reader; markedly brief; and in all cases, different than the commercial names. Three-letter all caps abbreviations, some with subscripts, were assigned to denote each of the approved neurotoxins and fillers. A common system of abbreviations for medical devices in dermatology may avoid the appearance of bias while ensuring effective communication. The proposed system may be expanded to name other devices, and the ensuing abbreviations may be suitable for journal articles, continuing medical education lectures, or other academic or clinical purposes. © 2013 by the American Society for Dermatologic Surgery, Inc. Published by Wiley Periodicals, Inc.

Antinuclear antibody panel

Science.gov (United States)

... page: //medlineplus.gov/ency/article/003535.htm Antinuclear antibody panel To use the sharing features on this page, please enable JavaScript. The antinuclear antibody panel is a blood test that looks at ...

Hepatitis virus panel

Science.gov (United States)

... page: //medlineplus.gov/ency/article/003558.htm Hepatitis virus panel To use the sharing features on this page, please enable JavaScript. The hepatitis virus panel is a series of blood tests used ...

Introduction of a method of constructing heat preventing panels in holds in freezing carrier. Reito unpansen ni okeru sonai bonetsu panel koho no shokai

Energy Technology Data Exchange (ETDEWEB)

Kawaki, T; Fujita, H; Yamamoto, K

1994-06-25

A freezing carrier is a dedication ship to transport frozen and refrigerated cargoes such as foodstuffs loaded in holds. Ship's heat preventing devices must have the heat insulating structure formed according to complex shapes characteristic to an ocean vessel, and the most part of the work is done by skilled technicians working on the site. Therefore, discussions have been given on a heat preventing structure using a panel construction method aiming at simplifying cross sections to more efficient and uniform shapes, and hold shapes and work in them to more suitable for palletized packaging styles, and improving working environments. The results of the discussions have been applied to two ships for the first time, and the effects have been verified. This paper reports its specifications and construction. The heat preventing panel is a sandwiched composite of a surface material and a polyurethane foam, made to a panel size of about 1 m [times] 2 m. Joints are fixed by fasteners. The present ships have adopted such a form that the side walls are vertical, but the floor area and the clear height are the same as the conventional construction methods. Good heat insulation performance and workability have been verified, and results that are expected of further development have been obtained. 7 figs.

REINFORCED COMPOSITE PANEL

DEFF Research Database (Denmark)

2003-01-01

A composite panel having front and back faces, the panel comprising facing reinforcement, backing reinforcement and matrix material binding to the facing and backing reinforcements, the facing and backing reinforcements each independently comprising one or more reinforcing sheets, the facing rein...... by matrix material, the facing and backing reinforcements being interconnected to resist out-of-plane relative movement. The reinforced composite panel is useful as a barrier element for shielding structures, equipment and personnel from blast and/or ballistic impact damage....

Rational Design of Composite Panels

DEFF Research Database (Denmark)

Riber, Hans Jørgen

1996-01-01

A non-linear structural model for composite panels is presented. The non-linear terms in the lateral displacements are modelled as an additional set of lateral loads acting on the panel. Hence the solution is reduced to that of an equivalent panel with small displacements In order to treat sandwich...... Norske Veritas', DNV, building rules concerning high-speed light craft, in which the panel scantlings are often restricted by a maximum lateral deflection connected with the panel span....

Association between change of health care providers and pregnancy exposure to FDA category C, D and X drugs.

Science.gov (United States)

Yang, Jianzhou; Xie, Rihua; Krewski, Daniel; Wang, Yongjin; Walker, Mark; Cao, Wenjun; Wen, Shi Wu

2014-01-01

Changing health care providers frequently breaks the continuity of care, which is associated with many health care problems. The purpose of this study was to examine the association between a change of health care providers and pregnancy exposure to FDA category C, D and X drugs. A 50% random sample of women who gave a birth in Saskatchewan between January 1, 1997 and December 31, 2000 were chosen for this study. The association between the number of changes in health care providers and with pregnancy exposure to category C, D, and X drugs for those women with and without chronic diseases were evaluated using multiple logistical regression, with adjusted odds ratios (ORs) and its 95% confidence intervals (CIs) as the association measures. A total of 18 568 women were included in this study. Rates of FDA C, D, and X drug uses were 14.35%, 17.07%, 21.72%, and 31.14%, in women with no change of provider, 1-2 changes, 3-5 changes, and more than 5 changes of health care providers. An association between the number of changes of health care providers and pregnancy exposure to FDA C, D, and X drugs existed in women without chronic diseases but not in women with chronic disease. Change of health care providers is associated with pregnancy exposure to FDA category C, D and X drugs in women without chronic diseases.

Composite panel development at JPL

Science.gov (United States)

Mcelroy, Paul; Helms, Rich

1988-01-01

Parametric computer studies can be use in a cost effective manner to determine optimized composite mirror panel designs. An InterDisciplinary computer Model (IDM) was created to aid in the development of high precision reflector panels for LDR. The materials properties, thermal responses, structural geometries, and radio/optical precision are synergistically analyzed for specific panel designs. Promising panels designs are fabricated and tested so that comparison with panel test results can be used to verify performance prediction models and accommodate design refinement. The iterative approach of computer design and model refinement with performance testing and materials optimization has shown good results for LDR panels.

Supersonic Panel Flutter Test Results for Flat Fiber-Glass Sandwich Panels with Foamed Cores

Science.gov (United States)

Tuovila, W. J.; Presnell, John G., Jr.

1961-01-01

Flutter tests have been made on flat panels having a 1/4 inch-thick plastic-foam core covered with thin fiber-glass laminates. The testing was done in the Langley Unitary Plan wind tunnel at Mach numbers from 1.76 t o 2.87. The flutter boundary for these panels was found to be near the flutter boundary of thin metal panels when compared on the basis of an equivalent panel stiffness. The results also demonstrated that the depth of the cavity behind the panel has a pronounced influence on flutter. Changing the cavity depth from 1 1/2 inches to 1/2 inch reduced the dynamic pressure at start of flutter by 40 percent. No flutter was obtained when the spacers on the back of the panel were against the bottom of the cavity.

Panel Resource Management (PRM) Implementation and Effects within Safety Review Panel Settings and Dynamics

Science.gov (United States)

Taylor, Robert W.; Nash, Sally K.

2007-01-01

While technical training and advanced degree's assure proficiency at specific tasks within engineering disciplines, they fail to address the potential for communication breakdown and decision making errors familiar to multicultural environments where language barriers, intimidating personalities and interdisciplinary misconceptions exist. In an effort to minimize these pitfalls to effective panel review, NASA's lead safety engineers to the ISS Safety Review Panel (SRP), and Payload Safety Review Panel (PSRP) initiated training with their engineers, in conjunction with the panel chairs, and began a Panel Resource Management (PRM) program. The intent of this program focuses on the ability to reduce the barriers inhibiting effective participation from all panel attendees by bolstering participants confidence levels through increased communication skills, situational awareness, debriefing, and a better technical understanding of requirements and systems.

Solar panel cleaning robot

Science.gov (United States)

Nalladhimmu, Pavan Kumar Reddy; Priyadarshini, S.

2018-04-01

As the demand of electricity is increasing, there is need to using the renewable sources to produce the energy at present of power shortage, the use of solar energy could be beneficial to great extent and easy to get the maximum efficiency. There is an urgent in improving the efficiency of solar power generation. Current solar panels setups take a major power loss when unwanted obstructions cover the surface of the panels. To make solar energy more efficiency of solar array systems must be maximized efficiency evaluation of PV panels, that has been discussed with particular attention to the presence of dust on the efficiency of the PV panels have been highlighted. This paper gives the how the solar panel cleaning system works and designing of the cleaning system.

Pressurized waterproof case for electronic device

KAUST Repository

Berumen, Michael L.

2013-01-31

The pressurized waterproof case for an electronic device is particularly adapted for the waterproof containment and operation of a touch-screen computer or the like therein at some appreciable water depth. The case may be formed as an enclosure having an open top panel or face covered by a flexible, transparent membrane or the like for the operation of the touch-screen device within the case. A pressurizing system is provided for the case to pressurize the case and the electronic device therein to slightly greater than ambient in order to prevent the external water pressure from bearing against the transparent membrane and pressing it against the touch screen, thereby precluding operation of the touch screen device within the case. The pressurizing system may be a small gas cartridge (e.g., CO2), or may be provided from an external source, such as the diver\\'s breathing air. A pressure relief valve is also provided.

Lightweight, Thermally Insulating Structural Panels

Science.gov (United States)

Eisen, Howard J.; Hickey, Gregory; Wen, Liang-Chi; Layman, William E.; Rainen, Richard A.; Birur, Gajanana C.

1996-01-01

Lightweight, thermally insulating panels that also serve as structural members developed. Honeycomb-core panel filled with low-thermal-conductivity, opacified silica aerogel preventing convection and minimizes internal radiation. Copper coating on face sheets reduces radiation. Overall thermal conductivities of panels smaller than state-of-art commercial non-structurally-supporting foam and fibrous insulations. On Earth, panels suitable for use in low-air-pressure environments in which lightweight, compact, structurally supporting insulation needed; for example, aboard high-altitude aircraft or in partially evacuated panels in refrigerators.

PERBANDINGAN UNJUK KERJA ANTARA PANEL SEL SURYA BERPENJEJAK DENGAN PANEL SEL SURYA DIAM

OpenAIRE

Syafaruddin Ch

2010-01-01

The ability to produce electrical energy at Solar Power Plant  is highly dependent on the magnitude and duration of sun exposure on the solar cell panels. The movement of the sun from east to west that periodicity in every day is a problem at  the  optimization generation of electricity at  Solar Power Plant   if using solar panel that motionless. This is because the solar cell panel can not catch the maximum sun exposure. To solve the above problem then designed a solar cell panel  tracker...

Medical device registration, agreements on mutual recognition - a step forward to global harmonization?

International Nuclear Information System (INIS)

Eidenberger, R.Reiner

2000-01-01

The purpose of this article is to give a short overview of some different regulations in Europe and the United States with regard to the clearance of medical devices and to give an outlook of what the Agreements on Mutual Recognition will bring in terms of Global Harmonization. Recent European legislation, the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (Medical Device Directive, MDD), requires that all medical devices placed on the European market bear the CE marking. From 14 June 1998, medical devices fall under the scope of this European Medical Device Directive and there is a harmonization within the European market. Similar to this, but for another market, are the USA FDA requirements, Premarket Approval (PMA) and Premarket notification (510(k)). The same medical device, the same goal - a safe product - but different legislation and thus duplication of registration procedures. The European Commission is presently discussing a series of agreements with third countries, Australia, New Zealand, USA, Canada, Japan and Eastern European countries wishing to join the EU, concerning the mutual acceptance of inspection bodies and, ultimately, proof of conformity (for example reports on examination, certificates, licenses and marks of conformity) in connection with medical devices. Meanwhile agreements with Australia, New Zealand, USA and Canada came into force. (author)

Integrated application of combined cooling, heating and power poly-generation PV radiant panel system of zero energy buildings

Science.gov (United States)

Yin, Baoquan

2018-02-01

A new type of combined cooling, heating and power of photovoltaic radiant panel (PV/R) module was proposed, and applied in the zero energy buildings in this paper. The energy system of this building is composed of PV/R module, low temperature difference terminal, energy storage, multi-source heat pump, energy balance control system. Radiant panel is attached on the backside of the PV module for cooling the PV, which is called PV/R module. During the daytime, the PV module was cooled down with the radiant panel, as the temperature coefficient influence, the power efficiency was increased by 8% to 14%, the radiant panel solar heat collecting efficiency was about 45%. Through the nocturnal radiant cooling, the PV/R cooling capacity could be 50 W/m2. For the multifunction energy device, the system shows the versatility during the heating, cooling and power used of building utilization all year round.

Panel data analysis using EViews

CERN Document Server

Agung, I Gusti Ngurah

2013-01-01

A comprehensive and accessible guide to panel data analysis using EViews software This book explores the use of EViews software in creating panel data analysis using appropriate empirical models and real datasets. Guidance is given on developing alternative descriptive statistical summaries for evaluation and providing policy analysis based on pool panel data. Various alternative models based on panel data are explored, including univariate general linear models, fixed effect models and causal models, and guidance on the advantages and disadvantages of each one is given. Panel Data Analysis

RECIPANEL: RECYCLED PAPER PANELS

Directory of Open Access Journals (Sweden)

HERNÁN CAÑOLA

2012-01-01

Full Text Available En este artículo se estudia la fabricación y el comportamiento mecánico de paneles a base de papel reciclado. El objetivo principal del proyecto es producir un prototipo de panel que emplee elementos provenientes de residuos sólidos (papel periódico y de un material conglomerante (cemento Portland blanco. El panel debe ser económico, debe tener buenas propiedades mecánicas y debe tener dimensiones comerciales para su uso en muros tabiques y en cielos falsos en la industria de la construcción. El Recipanel es un panel no estructural a base de papel reciclado. El Recipanel cumple las normas colombianas en lo relativo a los paneles de uso no estructural y presenta además unas excelentes características mecánicas.

New FDA-Approved Disease-Modifying Therapies for Multiple Sclerosis.

Science.gov (United States)

English, Clayton; Aloi, Joseph J

2015-04-01

Interferon injectables and glatiramer acetate have served as the primary disease-modifying treatments for multiple sclerosis (MS) since their introduction in the 1990s and are first-line treatments for relapsing-remitting forms of MS (RRMS). Many new drug therapies were launched since early 2010, expanding the drug treatment options considerably in a disease state that once had a limited treatment portfolio. The purpose of this review is to critically evaluate the safety profile and efficacy data of disease-modifying agents for MS approved by the US Food and Drug Administration (FDA) from 2010 to the present and provide cost and available pharmacoeconomic data about each new treatment. Peer-reviewed clinical trials, pharmacoeconomic studies, and relevant pharmacokinetic/pharmacologic studies were identified from MEDLINE (January 2000-December 2014) by using the search terms multiple sclerosis, fingolimod, teriflunomide, alemtuzumab, dimethyl fumarate, pegylated interferon, peginterferon beta-1a, glatiramer 3 times weekly, and pharmacoeconomics. Citations from available articles were also reviewed for additional references. The databases publically available at www.clinicaltrials.gov and www.fda.gov were searched for unpublished studies or studies currently in progress. A total of 5 new agents and 1 new dosage formulation were approved by the FDA for the treatment of RRMS since 2010. Peginterferon beta-1a and high-dose glatiramer acetate represent 2 new effective injectable options for MS that reduce burden of administration seen with traditional interferon and low-dose glatiramer acetate. Fingolimod, teriflunomide, and dimethyl fumarate represent new oral agents available for MS, and their efficacy in reducing annualized relapse rates is 48% to 55%, 22% to 36.3%, and 44% to 53%, respectively, compared with placebo. Alemtuzumab is a biologic given over a 2-year span that reduced annualized relapse rates by 55% in treatment-naive patients and by 49% in patients

76 FR 24494 - Draft Guidance for Industry and FDA Staff: Processing/Reprocessing Medical Devices in Health Care...

Science.gov (United States)

2011-05-02

..., you may submit written requests for single copies of the draft guidance to the Office of Communication... critical to ensuring a reusable device is appropriately prepared for its next use. II. Significance of.... 10.115). The draft guidance, when finalized, will represent the Agency's current thinking on...

[Twenty-year History and Future Challenges in Transparency Enhancement of Review Process for Approval: Focus on Public Release of Review Reports regarding New Drugs and Medical Devices].

Science.gov (United States)

Morimoto, Kazushige; Kawasaki, Satoko; Yoshida, Yasunori

2015-01-01

For 20 years, the Ministry of Health, Labour and Welfare (MHLW, formerly Ministry of Health and Welfare (MHW)) has been trying to increase transparency of the review process for approving reports in order to promote the rational use of newly approved drugs and medical devices. The first Summary Basis of Approval (SBA) was published by MHW in 1994. In 1999, evaluation reports were prepared by MHW and the Pharmaceuticals and Medical Devices Evaluation Center to make them available to the public. In 2005, a notice from the Chief Executive of the Pharmaceuticals and Medical Devices Agency (PMDA) made procedures for public release of information on reviewing applications for new drugs. In 2006, 90 review reports of newly approved drugs and eight medical devices were revealed on PMDA websites. The dissemination of information by the United States Food and Drug Administration (FDA) and that of the European Medicines Agency (EMA) were studied and compared with that of the MHLW and PMDA. While common technical documents (CTD) for new drugs and summary technical documents (STED) for new medical devices have been released by PMDA, such documents are not released by the FDA and EMA. The European Public Assessment Report (EAPR) summary for the public is an interesting questionnaire approach that uses the "What," "How" and "Why" format. Finally, future proposals for the next decade are also outlined.

2010 Panel on the Biomaterials Grand Challenges

Science.gov (United States)

Reichert, William “Monty”; Ratner, Buddy D.; Anderson, James; Coury, Art; Hoffman, Allan S.; Laurencin, Cato T.; Tirrell, David

2014-01-01

In 2009, the National Academy for Engineering issued the Grand Challenges for Engineering in the 21st Century comprised of 14 technical challenges that must be addressed to build a healthy, profitable, sustainable, and secure global community (http://www.engineeringchallenges.org). Although crucial, none of the NEA Grand Challenges adequately addressed the challenges that face the biomaterials community. In response to the NAE Grand Challenges, Monty Reichert of Duke University organized a panel entitled Grand Challenges in Biomaterials at the at the 2010 Society for Biomaterials Annual Meeting in Seattle. Six members of the National Academies—Buddy Ratner, James Anderson, Allan Hoffman, Art Coury, Cato Laurencin, and David Tirrell—were asked to propose a grand challenge to the audience that, if met, would significantly impact the future of biomaterials and medical devices. Successfully meeting these challenges will speed the 60-plus year transition from commodity, off-the-shelf biomaterials to bioengineered chemistries, and biomaterial devices that will significantly advance our ability to address patient needs and also to create new market opportunities. PMID:21171147

Make Your Own Solar Panel.

Science.gov (United States)

Suzuki, David

1992-01-01

Presents an activity in which students make a simulated solar panel to learn about the principles behind energy production using solar panels. Provides information about how solar panels function to produce energy. (MCO)

Awareness and trust of the FDA and CDC: Results from a national sample of US adults and adolescents.

Directory of Open Access Journals (Sweden)

Sarah D Kowitt

Full Text Available Trust in government agencies plays a key role in advancing these organizations' agendas, influencing behaviors, and effectively implementing policies. However, few studies have examined the extent to which individuals are aware of and trust the leading United States agencies devoted to protecting the public's health. Using two national samples of adolescents (N = 1,125 and adults (N = 5,014, we examined demographic factors, with a focus on vulnerable groups, as correlates of awareness of and trust in the Centers for Disease Control and Prevention (CDC, Food and Drug Administration (FDA, and the federal government. From nine different weighted and adjusted logistic regression models, we found high levels of awareness of the existence of the FDA and CDC (ranging from 55.7% for adolescents' awareness of the CDC to 94.3% for adults' awareness of the FDA and moderate levels of trust (ranging from a low of 41.8% for adults' trust in the federal government and a high of 78.8% for adolescents' trust of the FDA. In the adolescent and adult samples, awareness was higher among non-Hispanic Blacks and respondents with low numeracy. With respect to trust, few consistent demographic differences emerged. Our findings provide novel insights regarding awareness and trust in the federal government and specific United States public health agencies. Our findings suggest groups to whom these agencies may want to selectively communicate to enhance trust and thus facilitate their communication and regulatory agendas.

FDA-approved drugs that are spermatotoxic in animals and the utility of animal testing for human risk prediction.

Science.gov (United States)

Rayburn, Elizabeth R; Gao, Liang; Ding, Jiayi; Ding, Hongxia; Shao, Jun; Li, Haibo

2018-02-01

This study reviews FDA-approved drugs that negatively impact spermatozoa in animals, as well as how these findings reflect on observations in human male gametes. The FDA drug warning labels included in the DailyMed database and the peer-reviewed literature in the PubMed database were searched for information to identify single-ingredient, FDA-approved prescription drugs with spermatotoxic effects. A total of 235 unique, single-ingredient, FDA-approved drugs reported to be spermatotoxic in animals were identified in the drug labels. Forty-nine of these had documented negative effects on humans in either the drug label or literature, while 31 had no effect or a positive impact on human sperm. For the other 155 drugs that were spermatotoxic in animals, no human data was available. The current animal models are not very effective for predicting human spermatotoxicity, and there is limited information available about the impact of many drugs on human spermatozoa. New approaches should be designed that more accurately reflect the findings in men, including more studies on human sperm in vitro and studies using other systems (ex vivo tissue culture, xenograft models, in silico studies, etc.). In addition, the present data is often incomplete or reported in a manner that prevents interpretation of their clinical relevance. Changes should be made to the requirements for pre-clinical testing, drug surveillance, and the warning labels of drugs to ensure that the potential risks to human fertility are clearly indicated.

Incore instrument device

International Nuclear Information System (INIS)

Sakima, Naoki

1996-01-01

An incore instrument device has an integrally disposed touch panel having a function of displaying an operation indication method such as for setting of conditions for incore measurement and information processing and results of the incore measurement and a function capable of conducting operation indication such as for setting conditions and information processing for incore measurement relative to a control section upon touching an information position on a displayed information. In addition, an information processing section comprising a man-machine function program formed so as to recognize the content of the operation indication for the incore measurement by touching and let the control section to conduct it is disposed to the outside by way of a communication interface. In addition, a programming device is disposed for forming and rewriting the program of the man-machine function relative to the information processing section. Then, when various indication operations are conducted upon performing incore measurement, a view point can be concentrated to one predetermined point thereby enabling to improve the operationability without danger. In addition, the programming of the man-machine function does not apply unnecessary load to the control section in the incore instrumentation device. (N.H.)

Designs for mechanical circulatory support device studies.

Science.gov (United States)

Neaton, James D; Normand, Sharon-Lise; Gelijns, Annetine; Starling, Randall C; Mann, Douglas L; Konstam, Marvin A

2007-02-01

There is increased interest in mechanical circulatory support devices (MCSDs), such as implantable left ventricular assist devices (LVADs), as "destination" therapy for patients with advanced heart failure. Because patient availability to evaluate these devices is limited and randomized trials have been slow in enrolling patients, a workshop was convened to consider designs for MCSD development including alternatives to randomized trials. A workshop was jointly planned by the Heart Failure Society of America and the US Food and Drug Administration and was convened in March 2006. One of the panels was asked to review different designs for evaluating new MCSDs. Randomized trials have many advantages over studies with no controls or with nonrandomized concurrent or historical controls. These advantages include the elimination of bias in the assignment of treatments and the balancing, on average, of known and unknown baseline covariates that influence response. These advantages of randomization are particularly important for studies in which the treatments may not differ from one another by a large amount (eg, a head-to-head study of an approved LVAD with a new LVAD). However, researchers have found it difficult to recruit patients to randomized studies because the number of clinical sites that can carry out the studies is not large. Also, there is a reluctance to randomize patients when the control device is considered technologically inferior. Thus ways of improving the design of randomized trials were discussed, and the advantages and disadvantages of alternative designs were considered. The panel concluded that designs should include a randomized component. Randomized designs might be improved by allowing the control device to be chosen before randomization, by first conducting smaller vanguard studies, and by allowing crossovers in trials with optimal medical management controls. With use of data from completed trials, other databases, and registries, alternative

Seismic hazard analysis. Review panel, ground motion panel, and feedback results

International Nuclear Information System (INIS)

Bernreuter, D.L.

1981-10-01

The Site Specific Spectra Project (SSSP) was a multi-year study funded by the U.S. Nuclear Regulatory Commission to provide estimates of the seismic hazards at a number of nuclear power plant sites in the Eastern U.S. A key element of our approach was the Peer Review Panel, which we formed in order to ensure that our use of expert opinion was reasonable. We discuss the Peer Review Panel results and provide the complete text of each member's report. In order to improve the ground motion model, an Eastern U.S. Ground Motion Model Panel was formed. In Section 4 we tabulate the responses from the panel members to our feedback questionnaire and discuss the implications of changes introduced by them. We conclude that the net difference in seismic hazard values from those presented in Volume 4 is small and does not warrant a reanalysis. (author)