Submitted by kBLASTER Team on
by King & Spalding
Commentary on FDA's final guidance, The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notification [510(k)], which in a previous posting defined the role of a single primary predicate in a 510(k) submission and strongly discouraged "split predicates" 510(k) submissions. Excerpts from this commentary also clarified the role of reference devices:
--"Consistent with the draft version of the guidance, the final SE Guidance discusses the use of “reference devices.” Reference devices may be used to make FDA aware of a device(s) that may incorporate similar technology but has a different intended use, to support the use of scientific methods, or to support cited standard reference values. The SE Guidance explicitly states that reference devices are not considered predicate devices and therefore cannot be used as a comparison of the intended use of a device or for evaluating whether differences in technological characteristics raise new questions of safety or effectiveness. FDA intends to review the applicability of a reference device on a case-by- case basis. FDA also recommends that “if a manufacturer intends to use a reference device, the manufacturer should provide a scientific rationale that justifies its use.”