Submitted by kBLASTER Team on
by Alex Gaffney, RAC, for RAPS Regulatory News Focus
Commentary on FDA's final guidance titled The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notification [510(k)]. Excerpts from this commentary stated the following:
...companies would rely on "a single predicate" for a finding of substantial equivalence (or SE), FDA said. The rest would simply bolster an application's legitimacy. FDA also refers to this as the "primary predicate" in its guidance.
...FDA said it will no longer accept the concept of a "split predicate," which were used by some companies to compare their product to multiple already-cleared devices. FDA said that this was "inconsistent with the 510(k) regulatory standard."