Submitted by kBLASTER Team on
by Varun Saxena for Fierce Medical Devices
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...
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"...
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...
Submitted by kBLASTER Team on
An update was posted by the FDA on "How to find and effectively use Predicate Devices". This update stated that "Manufacturers must identify a primary predicate device which is most similar to the device under review with respect to indications for use and technological characteristics" and that "the use of split predicates is inconsistent with the 510(k) regulatory standard"....
Submitted by kBLASTER Team on
Final guidance was published by FDA on July 28, 2014 titled The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notification [510(k)]. This guidance recommends the identification of a single primary predicate in all 510(k) submissions and has ruled that the use of "split predicates as inconsistent with the 510(k) regulatory standard". Multiple predicates are still allowed, but each predicate used must have identical...