US FDA Clarifies 510(k) Submission and Substantial Equivalence Requirements
Submitted by kBLASTER Team on
by Stewart Eisenhart for Emergo Group
Commentary on FDA's final guidance titled The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notification [510(k)] which states a single primary predicate is needed for a 510(k) submission, as well as no longer allowing "split predicate" 510(k) submissions. Excerpts from this commentary stated the following:...