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)]. A previous posting had described the need for a single primary predicate and that split predicates would no longer be allowed. Excerpts from this commentary also stated the following regarding reference devices:
..."FDA also introduces the concept of "Reference devices" in the guidance, explaining that—similar to a predicate device—reference products "may be used to support scientific methodology or standard reference values." The utility of these devices will depend on their similarity to the new device, FDA said. Because it is not a predicate, FDA's guidance implies that the application of a "reference device" may be most useful in comparing technologies used within devices, instead of the devices as a whole."