Submitted by kBLASTER Team on
by Liza Burns for The Weinberg Group
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:
…”The release of the final version of this guidance cements certain changes to the core of the 510(k) program namely, FDA’s determination to disallow the use of ‘split predicates’ (using one predicate device for its intended use and another predicate device for technological characteristics)”
…”A 510(k) submission should not rely on ‘split predicates.’ FDA states that Decision Points 1 – 4 in the Flowchart should be established with one device.” This single predicate may also be called a primary predicate.
…”A primary predicate device should be clearly established…”