Submitted by kBLASTER Team on
by Ropes & Gray
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:
--Designation of a “primary predicate.” Unlike split predicates, FDA will accept multiple predicates in some circumstances. Multiple predicates are commonly relied upon when a 510(k) combines features from two or more previously marketed devices into a single, new device. In the guidance, FDA generally encourages the use of a single predicate to simplify the decision-making process. It also recommends that, when a manufacturer relies upon multiple predicates, the 510(k) identifies the “primary predicate,” which is “the one with indications for use and technological characteristics most similar” to the new device.
--Elimination of split predicates. The guidance states that the use of a “split predicate” is inconsistent with the 510(k) regulatory standard for demonstrating substantial equivalence. A 510(k) uses a “split predicate” when it compares the device that is the subject of the 510(k) (the “new device”) against one predicate device to show sameness of intended use, and a separate predicate device with a different intended use to show similarity of technological characteristics. Although FDA has been taking this position in practice for several years, this is the agency’s first official, final policy statement on this topic.