Submitted by kBLASTER Team on
by Arezu Sarvestani for Mass Device
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 "split predicate" method, although previously rubber-stamped by regulators, has since been deemed "inconsistent with the 510(k) regulatory standard," the FDA said. In new guidance, which was 2 years in the making, regulators asked device makers to rely on a single predicate device or devices that have the same intended purpose when establishing substantial equivalence (SE) for a new product.