Submitted by kBLASTER Team on
Commentary on regulatory and predicate requirement implications of FDA Draft Guidance for Industry and Food and Drug Administration Staff - The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] by Jonathan S. Kahan, Jennifer Agraz Henderson, Kelliann H. Payne for Update Magazine , The Food and Drug Law Institute, July/August 2012
Excerpts from this commentary highlights that the FDA guidance focused on major points relative to primary predicates and reference devices which include:
"Breaking from prior practice, FDA now recommends that manufacturers identify a “primary predicate” to support substantial equivalence. Notably, the draft more narrowly defines the circumstances for using multiple predicates than 510(k) Memorandum K86-3, which specifically discusses the use of combination predicates where a device “claims to have the same intended uses as two or more different types of predicate devices.” In addition, all primary predicates must satisfy Decision Points 1 through 4 in the revised flowchart, meaning each predicate device must have the same intended use as the new device. Moreover, if the devices have different technological characteristics, the new device must not raise different questions of safety or effectiveness. The proposed framework may, therefore, further limit the use of multiple predicates, potentially making it more difficult for manufacturers to support substantial equivalence decisions. This framework also effectively precludes the ability to use a “split predicate” analysis, i.e, using one predicate to support equivalence in intended use and another predicate to support equivalence in technological characteristics. Indeed, the Draft Guidance reiterates the agency’s recent position, heretofore unsupported, from its August 2010 510(k) Working Group report that use of one predicate to support an intended use, and another, separate predicate to support technological characteristics."
"The Draft Guidance also creates a new category of devices - reference devices – that are used to address a performance characteristic in support of a substantial equivalence determination, but that are not considered predicates per se. For instance, a reference device might have a different intended use than a new device, but provide scientific information about a technological characteristic, such as a new chemical coating, that distinguishes a new device from its predicates. If the reference device uses the same chemical coating, it might provide needed information about the biocompatibility and scientific characteristics of the new device to support the substantial equivalence determination. Unfortunately, the Draft Guidance does not provide a clear framework for use of reference devices, either by manufacturers or by FDA. For example, while the Draft Guidance implies that reference devices should be listed in a 510(k) summary, it does not specify whether these devices must be listed in a submission’s substantial equivalence table. Perhaps most importantly, FDA appears to have considerable leeway in determining when it will accept, and how it will handle, reference devices in a given application, and it is not clear how consistency regarding the use of reference devices will be assured."