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)] stated in a previous posting that a single primary predicate is needed for a 510(k) submission and that "split predicate" 510(k) submissions are no longer allowed. Clarifications were also presented on reference devices and instances were given on how they could be used. Excerpts from this commentary stated the following:
--"The guidance also emphasizes a sharp distinction between predicate devices and reference devices. Reference devices can be identified by applicants to support acceptable scientific methods. Manufacturers should be aware that FDA reviewers do not consider reference devices acceptable substitutes for predicate devices; applicants must also provide scientific rationale to support their use of reference devices in their SE applications."