AAMI News January 2019

FDA Eyes Changes to Predicate Device-Based Approvals

The Food and Drug Administration (FDA) is re-evaluating the way medical device manufacturers gain 510(k) premarket clearance for their products in a move described as a “generational change” by FDA Commissioner Scott Gottlieb and Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health.

To gain 510(k) clearance, manufacturers compare new designs to previous iterations of a device, called predicate devices. This was a path taken by more than eight in 10 devices cleared by the agency in 2017, according to the FDA.

“We believe firmly in the merits of the 510(k) process. But we also believe that framework needs to be modernized to reflect advances in technology, safety, and the capabilities of a new generation of medical devices,” Gottlieb and Shuren said in a joint statement.

The future of the 510(k) program is envisioned as the Expanded Abbreviated pathway, introduced in an April 2018 guidance document, which Gottlieb and Shuren said would be renamed the “Safety and Performance Based Pathway.” This new 510(k) pathway would allow manufacturers to compare the performance of some medical devices to FDA-identified criteria rather than measuring them against predicates. The FDA plans to release final guidance this year to establish the program, which Gottlieb and Shuren said they hope would eventually supplant predicate device comparisons.

In the interim, the FDA is considering publishing a list of medical devices on its website that were approved based on predicates that are more than 10 years old, a move that would affect roughly 20% of 510(k)-approved devices. The goal of this “market-based” approach, according to Gottlieb and Shuren, is to “drive sponsors to continually offer patients devices with the latest improvements and advances.”

“We don’t believe devices that rely on old predicates are unsafe, or that older devices need to be removed from the market,” Gottlieb and Shuren explained. “However, we believe that encouraging product developers to use more modern predicates would … help the overall product environment continue to evolve in the direction toward more modern performance standards.”

The FDA intends to seek public feedback on whether to publish this list, whether other criteria should inform the agency’s point of reference, and whether there are other actions the agency should take to promote the use of more modern predicates.