FDA issues draft guidance on appeals process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The FDA issues draft guidance on its 517A appeals process for medical device review decisions.

FDA issues draft guidance on appeals process

The FDA today released draft guidance clarifying existing recommendations for how medical device manufacturers can appeal the federal watchdog agency's decisions on marketing applications.

The draft guidance, which the FDA is asking industry to comment on over the next 90 days, pertains to requests for documentation of rationales for significant decisions and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.

The draft defines what a "significant decision" is, something that was previously not specified. Significant decisions are now restricted to 510(k): not substantially equivalent or substantially equivalent; PMA/HDE: not approvable or approvable with conditions; approval IDE: disapproval or approval; or
failure to reach agreement on a protocol.

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The agency does not believe that actions earlier in the review process constitute "significant decisions." Thus, the FDA is not required to respond to appeals to any of the following: Refusals to accept/file, requests for additional information, or deficiency letters during the review of a premarket submission.

The FD&C Act requires the FDA to provide, upon request of a person who is seeking to submit or who has submitted a 510(k), PMA, IDE, or HDE, a "substantive summary" of the scientific and regulatory rationale for any significant decision regarding the submission, including documentation of significant controversies or differences of opinion and the resolution thereof, the draft guidance stated.