FDA moves to modernize 510(k) clearance program for medical devices

The Food and Drug Administration on Monday announced changes meant to modernize the agency’s 510(k) clearance program and to advance its review of the safety and effectiveness of medical devices.

While the FDA’s 510(k) clearance pathway accounts for the majority of devices that the agency reviews, Congress passed the law establishing the regulatory framework 42 years ago and it is in sore need of changes to help keep pace with rapidly evolving technology, according to the agency.

“We believe that where appropriate, new medical devices that come to market under the 510(k) pathway should either account for advances in technology or demonstrate that they meet more modern safety and performance criteria,” said FDA Commissioner Scott Gottlieb, MD, and Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, in a written statement.

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In particular, Gottlieb and Shuren pointed to advances in material science, digital health, 3D printing and other technologies that are driving medical device innovation, which they contend not only requires the agency to keep pace with technology but also to stay ahead of it.

They also noted that newer devices are more complex and are often interconnected and interoperable, which increases potential cybersecurity threats.

“We want to make sure that new devices are evaluated against advances in technology that can improve patient safety and performance,” added Gottlieb and Shuren, who called the FDA’s initiative a contemporary approach to regulation. “At the same time, we’re going to pursue additional actions that will allow the FDA to retire outdated predicates, especially in cases where we’ve seen safer or more effective technology emerge.”

Last year, the FDA’s Center for Devices and Radiological Health cleared 3,173 medical devices through the 510(k) process, accounting for 82 percent of the total devices cleared or approved. However, the agency’s data show that nearly 20 percent of current 510(k) clearances are based on a predicate that’s more than 10 years old.

“We believe that newer devices should be compared to the benefits and risks of more modern technology; that is why we’re looking at ways to promote the use of more recent predicates,” said Gottlieb and Shuren. “To advance these goals, in the next few months CDRH is considering making public on its website those cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are more than 10 years old as a starting point, so that the public is aware of those technologies.”

The FDA is seeking public feedback on whether the agency should make public those devices or those manufacturers who make technologies that rely on predicates that are more than 10 years old, whether other criteria should inform the FDA’s point of reference, and whether there are other actions it should take to promote the use of more modern predicates.

Ultimately, the FDA plans to finalize guidance in early 2019 creating “an alternative 510(k) pathway that allows manufacturers of certain well-understood device types to rely on objective safety and performance criteria to demonstrate substantial equivalence as a way to make it more efficient to adopt modern criteria as the basis for the predicates that are used to support new products.”

In addition, the agency intends to rename this new approach the “Safety and Performance Based Pathway” to reflect its new focus.

At the same time, Gottlieb and Shuren emphasized that devices that rely on old predicates are not inherently unsafe, and they offered reassurance that older devices do not need to be removed from the market.

“We believe that encouraging product developers to use more modern predicates would give patients and their doctors a choice among older and newer versions of a type of device, promote greater competition to adopt modern features that improve safety and performance, and help make sure that newer devices reflect more modern technology and standards that can improve patient care and outcomes,” concluded Gottlieb and Shuren.

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