Submitted by kBLASTER Team on
by Vesa Janic on January 26, 2012
Commentary on regulatory and predicate requirement implications of FDA Draft Guidance for Industry and Food and Drug Administration Staff - The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]. An excerpt from this commentary highlights that the FDA guidance focused on major points which include:
- The FDA will continue to allow the use of multiple predicates in certain circumstances to help demonstrate SE, however, the FDA recommends the use of primary predicate device to which an SE claim is being made.
- The use of “reference devices” was introduced. Reference devices would be used to support SE claims by industry in some situations where “split predicates” were previously used. Scientific rationale has to justify the use of a reference device.
- The guidance provides several illustrative examples on how to use multiple predicates, reference devices, indication for use, technological characteristics and when clinical data is needed.