Submitted by kBLASTER Team on
by Beau Hooks for DrugWatch
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 FDA states that there must be a primary predicate device cited in the 510(k) application to demonstrate the similarities. For a new device to meet the 510(k) guidelines, it must have the same intended use as the predicate. It must also have the same technological characteristics and do not raise safety and effectiveness concerns. The new standards points out that predicate devices may not have been removed from the market by FDA order or “determined misbranded or adulterated by judicial order.”
--”In some cases, in which a device has the same intended use as one predicate device and the same technological features as another predicate device, manufacturers push these split-predicate products. Moving forward, this is “inconsistent” with the 510(k) process, the FDA said, and those devices will not gain approval.”