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FDA Voice blog: FDA Celebrates the 40th Anniversary of the Medical Device Amendments
By: Jeffrey Shuren, M.D., J.D. In 1976, Steve Jobs and Steve Wozniak founded Apple and a gallon of gas was $.59. And in another action that has had long term impact, President Ford signed the Medical Device Amendments that closed the dangerous gap between what he called FDA’s “horse and buggy authority” and “laser age…
Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices
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Emergency Use Authorizations
OraQuick® Ebola Rapid Antigen Test (OraSure Technologies, Inc.) – For Use with whole Blood – July 31, 2015 On July 31, 2015, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the OraQuick® Ebola Rapid Antigen Test for the presumptive detection of Ebola Zaire virus (detected in the West Africa…
Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies
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Announcing Final Guidance on Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" and FDA Webinar on the Final Guidance
On July 21, 2016, the FDA will hold a webinar for industry to review the Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” final guidance document. The recommendations in this final guidance clarify and update how medical device developers may use…
Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150040 added)
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Webinar – Draft Guidance: 'Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions'
On Monday, July 11, 2016, the FDA will host a webinar to share information and answer questions about its draft guidance entitled ‘Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions.’ This draft guidance released on June 15, 2015, focuses on the factors the FDA may consider when making decisions…