FDA releases draft guidance on medical device applications

The Food and Drug Administration unveiled draft guidance Wednesday on how it reviews applications for low-risk medical devices under the 510(k) program and is requesting industry comment.

The FDA has been working with industry and patient advocacy groups to overhaul its so-called 510(k) program, which medical device makers complain has grown too complicated and uncertain. The draft guidance is not final and is not currently in effect, but gives stakeholders a chance to comment before the agency begins to develop its final guidance.

Comments are due by April 26, 2012.



Julian Pecquet – The Hill/Heath Watch Blog 12/29/11

U.S. Food and Drug Administration – Draft Guidance for Industry and Food and Drug Administration Staff – The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]


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