FDA ISSUES DRAFT GUIDANCE ON EVALUATING SUBSTANTIAL EQUIVALENCE IN 510(K) PREMARKET NOTIFICATIONS
Submitted by kBLASTER Team on
Commentary by Covington & Burling LLP on the regulatory and predicate requirement implications of FDA Draft Guidance for Industry and Food and Drug Administration Staff - The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]. February 7, 2012.
This commentary included analysis specific to FDA guidance comments...