FDA issues highly-anticipated Draft Guidance on the 510(k) Program

On 27 December 2011, the Food and Drug Administration (FDA or "the Agency") issued a new draft guidance document on the 510(k) program titled Draft Guidance for Industry and Food and Drug Administration Staff: The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] ("Draft 510(k) Paradigm Guidance" or "the new guidance"). The Draft 510(k) Paradigm Guidance clarifies key aspects of the substantial equivalence standard at the heart of the 510(k) program that, over the last few years, have attracted significant attention. It also sets forth new policies regarding Special 510(k) submissions, and clarifies when it is appropriate for manufacturers to submit Abbreviated 510(k) submissions to FDA. The Agency is seeking comments on the draft guidance by 26 April 2012.

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