FDA Eyes Shift Away from Predicate Device–Based Approvals


Posted November 30, 2018

For more than four decades, medical device manufacturers have relied on comparing new designs against previous iterations of a device, called predicate devices, as a way to gain approval from the Food and Drug Administration (FDA) through its 510(k) premarket clearance process. But now the agency is looking to make what FDA Commissioner Scott Gottlieb and Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, call a “generational change” away from those comparisons as it seeks to modernize the 510(k) premarket clearance process.

“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.

More than eight in 10 medical devices were cleared through the 510(k) pathway last year, according to the FDA. Out of those devices receiving 510(k) clearance, nearly 20% based their submission on a predicate device that’s more than a decade old. While that doesn’t reflect on the device’s ultimate effectiveness or safety, it may mean that the devices aren’t undergoing significant improvements, Gottlieb and Shuren said.

To accelerate the process away from predicate device comparisons, the FDA is considering publishing a list of medical devices that were approved based on predicate devices that are more than 10 years old. This “market-based” approach would be transparent, Gottlieb and Shuren explained, by giving patients a choice between older and newer versions of a type of device and promoting competition. In addition, the FDA will consider phasing out some older predicate devices.

“We want to make sure that new devices are evaluated against advances in technology that can improve patient safety and performance. In making these reviews, where appropriate, we want to rely on modern safety and performance criteria,” Gottlieb and Shuren said. “We recognize that our approach as regulators must continue to evolve, to anticipate and meet the challenges and opportunities of the coming decades. We must look ahead. We not only have to skate to where the puck will be, we also need to drive the puck to where it should be.”

The FDA has taken steps in recent years to streamline and modernize its premarket approval process for medical devices, such as an effort to streamline 510(k) third-party reviews and the establishment of a faster pathway to clearance for certain well-defined modifications to a manufacturer’s own medical device.

The future of the 510(k) program is envisioned as the Expanded Abbreviated pathway, which Gottlieb and Shuren announced will be renamed as the “Safety and Performance Based Pathway.” The FDA outlined this program in an April draft guidance document that received mixed reviews from the industry. This new 510(k) pathway allows medical device 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 next year to establish the program, which Gottlieb and Shuren said they hope will eventually supplant predicate device comparisons.

“Sometimes, by relying on old predicates, it can actually make it more difficult for more advanced technology to reach patients since it’s harder for an innovative product to bridge to an outdated technology reflected in a decades-old predicate,” Gottlieb and Shuren said. “Our new proposed approach enables us to help improve safety and performance, as appropriate, and ensure new products can more easily reflect beneficial new advances.”

As a result of these changes, the FDA expects more medical devices to seek approval through its de novo pathway, a process that “permits a robust evaluation of novel devices and allows the FDA to establish special controls for devices of the same type,” Shuren and Gottlieb said. The FDA plans to issue a proposed rule that would clarify procedures and requirements for de novo requests.