Devices & Diagnostics Letter

Oct. 22, 2012 | Vol. 39 No. 42

FDA Details Time Clock Strategies for PMAs, 510(k)s in Draft Guidance

The FDA last week released updated guidance describing how it intends to comply with submission review timelines set during user fee negotiations earlier this year.

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U.S. FDA Issues Final Guidances on 510(k) Refuse-to-Accept, PMA Review Policies 510(k), PMA Acceptance Guidelines Finalized as of First of Year U.S. FDA Draft Guidance Lays Out Time Clock Strategies for PMAs, 510(k)s Tougher Data Needed to Support PMA, 510(k) Submissions, Expert Says

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