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Finalized and Draft 510(k) Guidance Documents Formalize and Clarify FDA's Evaluation of Substantial Equivalence

05 August 2014

Medical Device Alert

On July 28, 2014, the U.S. Food and Drug Administration (FDA) finalized its guidance, The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] (Final Guidance), the draft version of which was released two and a half years ago, on December 27, 2011 (2011 Draft Guidance) and discussed in our January 12, 2012 Medical Device Alert. This document supersedes the FDA’s 1986 guidance, CDRH Premarket Notification Review Program, 510(k) Memorandum K86-3, and provides insight into the FDA’s current review practices for premarket notification (510(k)) submissions.

Read More: Finalized and Draft 510(k) Guidance Documents Formalize and Clarify FDA's Evaluation of Substantial Equivalence

The team

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