FInal Guidance for Industry and Food and Drug Administration Staff - The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]
Submitted by kBLASTER Team on
Final Guidance was published by FDA on July 28, 2014 titled The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notification [510(k)]. As reported in previous posting, guidance recommends the identification of a single primary predicate in all 510(k) submissions, has ruled that the use of "split predicates as...