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…
Transcript posted for May 24, 2016 Circulatory System Devices Panel of the Medical Devices Advisory Committee meeting
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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…
Check the CDRH Customer Service Rating
This page provides real time results for CDRH’s customer satisfaction survey for the current rating period. About the Survey: On June 16, 2014, CDRH launched the Customer Satisfaction survey. The survey was revised between December 14, 2015 and February 1, 2016. CDRH measures customer satisfaction in six months intervals. CDRH Customer Satisfaction Rating: Results below…
Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150040 added)
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