Substantial Guidance For The FDA's 510(k) Program

Law360, New York (January 25, 2012, 1:59 PM EST) -- On Dec. 27, 2011, the U.S. Food and Drug Administration (FDA) issued a new draft guidance document on the 510(k) program titled Draft Guidance for Industry and Food and Drug Administration Staff: The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] (Draft 510(k)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).

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,...
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