Submitted by kBLASTER Team on
by Arezu Sarvestani for Mass Device, posted in OrthoSpine News
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:
..."Federal medical device regulators finalized a new guidance this week that prohibits manufacturers from using so-called “split predicates”
..."this means that device makers can no longer reference separate predicate devices that have different intended uses when attempting to demonstrate “substantial equivalence.” Companies must now rely on a single predicate device or devices that have the same intended purpose."