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 as reported in previous posting states a single primary predicate is needed for a 510(k) submission, as well as no longer allowing "split predicate" 510(k) submissions. This guidance also discusses the new term of “reference devices” and how they can be used in 510(k) submissions. The following excerpts were taken from this guidance which further clarify the use of reference devices:
--Explanation of “reference devices.” The guidance discusses the use of “reference devices,” which, like the term “primary predicate,” does not appear in the statute or FDA regulations. Reference devices are legally marketed devices, other than the predicate device(s), that are referred to in a 510(k) to help support the use of particular scientific methods or reference values. The guidance states that a manufacturer intending to rely upon a reference device should provide a scientific rationale for its use.