FDA: Updated predicate devices will improve safety, efficacy in 510(k) clearances

The FDA yesterday released a notice explaining why it believes a push for modernizing predicate devices used in equivalence testing within the 510(k) clearance pathway will improve overall safety and effectiveness.

The plan to move towards newer predicate devices is part of the federal watchdog’s larger plans to “modernize” its 510(k) pathway and make itself the gold standard regulatory body globally, which it released details on earlier this month.

In a posting released today, FDA head Dr. Scott Gottlieb said that older predicate devices may not “reflect the newest performance standards” or the agency’s most recent understanding of the benefits and risks of such devices.

“We want to create policy vehicles that will move the market towards reliance on newer predicates that reflect more modern characteristics related to their safety and performance,” Dr. Gottlieb wrote in the release.

As announced earlier this week, those policies include making information about devices cleared based on substantial equivalence to systems 10 years or older available to the public. The federal watchdog said that it will be seeking public feedback on whether 10 year old devices “are the right starting point” and if there are other actions it could take to encourage the use of modern predicates.

Between 2015 and 2018, approximately 20% of 510(k)s cleared by the FDA were based on substantial equivalence to predicates that were more than 10 years old, Gottlieb wrote in the release.

“We don’t think these devices are unsafe—they met our standards for reasonable assurance of safety and effectiveness—but we are concerned that this practice of relying on predicates that are old, and may not reflect modern performance characteristics, means that some devices are not continually improving. Yet beneficial iteration is at the heart of health technology advancements that can truly benefit patients,” Dr. Gottlieb said.

As complexity increases and interconnectivity among devices becomes more important, so to does testing devices that incorporate the latest protections against cybersecurity threats, the FDA said. Other devices, such as those that use radiofrequency technology or laser technology, “may not meet the newer consensus standards adopted by the FDA,” the federal watchdog wrote.

The agency said that it will work to identify device types where “there are clear benefits to relying on more modern technology to demonstrate substantial equivalence and obtain FDA clearance of a 510(k).”

“We want to push product developers to embrace newer predicates with improvements in technology so that patients and providers will continually have access to safer and more effective devices. At the same time that we pursue efforts to sunset older predicates, we are advancing new policies to make it more efficient to develop new predicates that reflect modern principles of safety and performance,” Dr. Gottlieb wrote in the release.

The FDA said that it will continue to update on efforts to improve its functionality.

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