Reforming the 510(k) Process: Where We Are, How We Got Here, and What’s to Come

by Chris Henza and Geoff Hutchins for Medical Device and Diagnostic Industry (MDDI)

Commentary on regulatory and predicate requirement implications of FDA Draft Guidance for Industry and Food and Drug Administration Staff - The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].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 stated the following:

Given the release of the “The 510(k) Program” document, it is clear that FDA is standing firmly behind the 510(k) process and is committed to its ongoing improvement. Although the released guidances are in draft form, we anticipate that FDA will apply these guidances immediately.

As time unfolds, we expect this reform to have the following effect:

  • A higher standard for the selection of the predicate device.
  • A higher standard for claiming substantial equivalence.
  • Limitation on the use of split predicates and multiple predicates.
  • Greater use of the de novo process.
  • Higher probability of a NSE determination.
  • Greater consistency and predictability of the process.
  • FDA’s willingness to continually review and improve the 510(k) process is a critical part of its ongoing mission to provide American patients with safety, efficacy and innovation in medical devices.