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:
--"Most significantly, the guidance states that 510(k) registrant may no longer use “split predicates” in their SE applications—in other words, an applicant may not claim that its device has the same intended use as one marketed device and the same technological profile as another marketed device to show substantial equivalence. Rather, the FDA asserts that its reviewers must be able to verify SE to just one predicate device; use of split predicates could result in Not Substantially Equivalent (NSE) decisions.” This single predicate can also be called a primary predicate
--“However, the FDA will continue allowing manufacturers to use multiple predicate devices in some instances, but those predicate devices must have the same intended uses. Furthermore, agency reviewers will consider the validity of firms’ multiple-predicate SE applications on a case-by-case basis.”