The U.S. Food and Drug Administration (FDA) has followed through on plans announced last year to update its approval pathways for new medical devices. The recently announced “Safety and Performance Based Pathway” Guidance for Industry and Food and Drug Administration issued on January 22, 2019, sets out a strengthened 510(k) review process that the FDA believes will enhance the safety of new medical devices.

The Safety and Performance based Pathway, according to FDA, is designed to “ensure that the 510(k) program is keeping pace with the important innovations we’re seeing in device development.”

In the past, manufacturers bringing new devices through the 510(k) process often relied on comparison testing to so-called “predicate devices” in order to demonstrate that their newer, but still similar device, was as safe and effective as the predicate device. However, in many instances the predicate devices have been old and not reflective of modern technology. The updated Pathway, per FDA, is designed to ensure that the performance characteristics of new devices are evaluated against “a set of objective, transparent and well-validated safety and performance metrics.”

As described in statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, the new approval “option for 510(k) clearance will modernize our approach to moderate risk devices by allowing manufacturers to use objective performance criteria established or recognized by the FDA to facilitate demonstration of substantial equivalence of their new products to legally marketed devices…. By using this pathway, manufacturers would have demonstrated that their products meet objective safety and performance criteria that are based on modern technological principles.”

In order to facilitate the new Pathway, FDA plans on creating a list of device types that would be appropriate for the Pathway and establish safety and performance criteria for those types. In that regard, FDA intends to request public comment on those criteria and also on what other steps it may take to enhance medical device safety, including:

  • Should the FDA make public a list of devices, or manufacturers who make technologies, that rely on predicates that have been on the market for more than a certain number of years (e.g., 10 years)? If so, what would be an appropriate period of time?
  • Should the FDA consider using other criteria to inform our point of reference?
  • Are there other and/or alternative actions we should take to promote the development and marketing of safer, more effective 510(k) devices?
  • Should the FDA consider certain actions that might require new authority, such as making at least some older devices ineligible as predicates?

The comment period on the above-questions is open for the next 90 days.

The FisherBroyles Pharmacy and Health Care Law team is pleased to keep you updated on events of interest to those in the healthcare, medical device, and pharmaceutical industries. Questions may be directed to any of the following attorneys:

Brian Dickerson, FisherBroyles Partner
Brian E. Dickerson

Anthony Calamunci, FisherBroyles Partner
Anthony Calamunci

Nicole Waid, FisherBroyles Partner
Nicole Hughes Waid

Amy Butler, FisherBroyles Partner
Amy Butler