FDA releases 510(k) modernization plans

The FDA today released plans for updating its 510(k) clearance pathway, including a push to move away from using predicate devices over 10 years old and the creation of a new alternative 510(k) pathway that will allow approval based on objective safety and performance criteria.

In an official posting, FDA head Dr. Scott Gottliebb and FDA Center for Devices and Radiological Health head Dr. Jeff Shuren laid out plans the agency has for “modernizing” its 510(k) clearance pathway.

The release builds upon a strategy the federal watchdog laid out last week intended to improve overall post-market medical device oversight and to make the FDA “consistently first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices.”

In their update, the FDA heads said they “believe firmly in the merits of the 510(k) process,” but that they believe the system must be modernized to “reflect advances in technology, safety and the capabilities of a new generation of medical devices.”

“The 510(k) pathway represents a more contemporary approach to the risk-based regulation of medical products, but this doesn’t mean the pathway is perfect or not in need of change,” FDA heads Gottlieb and Shuren wrote in the release.

The first major change announced for the regulatory pathway is promoting the use of modern predicates for approvals to be based upon, according to the release.

“Nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old,” FDA heads wrote in the posting.

The FDA went on to say that it is considering making devices that demonstrated substantial equivalence based on older predicate devices public on the CDRH website, focusing on those based on devices 10 years or older.

“Our goal in focusing on older predicates is to drive sponsors to continually offer patients devices with the latest improvements and advances,” FDA heads wrote.

The agency clarified that it doesn’t believe devices more than 10 years old are unsafe, or that such devices would need to be removed from the market, but that it is looking to encourage developers to use more modern predicates. Such a push, the agency hopes, will improve competition to adopt modern features and increase selection choice between old and newer devices while improving overall standards and improving outcomes.

Other efforts include a potential “sunset” to older predicates to promote the use of more modern devices for comparison, the FDA said in its release.

Moving away from issues with older predicate devices, the FDA said that, beginning next year, it intends to finalize guidelines which would create an alternative 510(k) pathway that would allow producers of well-known device types to demonstrate substantial equivalence through objective safety and performance criteria, saying that they “believe this approach is the future of the 510(k) program.”

“Rather than looking to the past as a baseline for safety and effectiveness – and rely on predicate devices that are sometimes decades old as our point of comparison – our premarket review would be based on a contemporary baseline that looks to the future and a baseline that can be updated as technologies advance,” FDA heads wrote.

Through the new route, dubbed the “Safety and Performance Based Pathway,” a company would only have to demonstrate that their device meets performance-based criteria that the FDA has set to achieve approval, according to the release. The criteria would be based upon the safety and performance of modern predicate devices, the agency added.

The pathway would be a “direct and transparent approach” to demonstrating the safety and effectiveness of low to moderate risk devices, the federal watchdog said.

“This alternative pathway to substantial equivalence would provide more direct evidence of the safety and performance of a device and better information for patients and providers to make well-informed health care decisions. In addition, with this new approach, the FDA may drive greater market competition to develop safer devices. Manufacturers would be able to demonstrate that their products meet or exceed objective safety and performance criteria that are based on modern technological principles. And companies could also, for the purposes of supporting coverage decisions, more readily demonstrate to payors that their products perform better than other devices on the market,” the FDA heads wrote.

In addition to its new plans, the FDA also released a performance report touting its improvements to the 510(k) program, including an increase in page size and a decrease in overall average time to decision.

“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 wrote in its release.

As a result of the modernized 510(k) plans, the agency said it expects that it will receive more interest in the de novo pathway, and said that it will be releasing a proposed rule “clarifying procedures and requirements for submissions of de novo requests.”

The agency said it will also continue to release updates on its progress and the status of its Medical Device Safety Action Plan.