Medical Device Update: FDA Issues Final Guidance on 510(k) Determinations, Use of “Split” Predicates Strongly Discouraged

by  M. Elizabeth Bierman and Michele L. Buenafe for Morgan Lewis

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:

--"In the new guidance, FDA encourages manufacturers to identify a single predicate device to demonstrate substantial equivalence"

--"Although the guidance does not state explicitly that split predicates will not be accepted, the clear implication is that using split predicates will not lead to a finding of substantial equivalence."

--..."the guidance recommends that there be a “primary predicate,” with indications for use and technological characteristics that are most similar to the device that is the subject of the 510(k)."