FDA’s Substantial Equivalence Guidance Describes FDA’s Process for Evaluating Substantial Equivalence and Updates to the 510(k) Decision Flowchart

by FDA & Life Sciences Practice Group for King & Spalding

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:

--"According to the SE Guidance, comparison to a single predicate in a 510(k) submission is optimal..."

--"If an applicant cites to multiple predicate devices FDA recommends identifying a “primary predicate” in the submission. The SE Guidance defines the primary predicate as the device “with indications for use and technological characteristics most similar to the device under review.” Identifying a primary predicate will help facilitate the 510(k) review."

--"The SE Guidance clearly states that use of “a ‘split predicate’ is inconsistent with the 510(k) regulatory standard” and therefore cannot be used to support a substantial equivalence determination. A “split predicate” is defined as “ a situation in which a manufacturer is attempting to ‘split’ the 510(k) decision making process by demonstrating that a new device has the same intended use as one marketed device while comparing the new device’s technological characteristics with a second marketed device that has a different intended use.” As a general matter, FDA must be able to determine whether (1) a new device has the same intended use and (2) any different technological characteristics of the new device raise new questions of safety or effectiveness, using a single predicate device."