FDA Draft Guidance The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]

• By: www.fda.gov
• Date: March 01, 2012

On December 27, 2011, the FDA released new draft guidance on 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications. The guidance aims to explain the decision-making process of FDA for determining substantial equivalence and provides additional details about the regulations, strategies, and norms upon which the FDA’s review of the 510(k) application is based. The guidance also provides information about new policies regarding Special 510(k) and Abbreviated 510(k) submissions to FDA.

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