FDA issues draft guidance on appeals process

May 16, 2013 by Ingrid Mezo

The FDA issues draft guidance on its 517A appeals process for medical device review decisions.

FDA issues draft guidance on appeals process

The FDA today released draft guidance clarifying existing recommendations for how medical device manufacturers can appeal the federal watchdog agency's decisions on marketing applications.

The draft guidance, which the FDA is asking industry to comment on over the next 90 days, pertains to requests for documentation of rationales for significant decisions and requests for supervisory review of regulatory decisions and actions taken by the FDA's Center for Devices & Radiological Health.

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