The U.S. Food and Drug Administration is considering policy changes that would require medical device makers to compare their products to more modern devices when seeking approval through the FDA's 510(k) pathway.

FDA Commissioner Scott Gottlieb and Jeff Shuren, the director of the agency's Center for Devices and Radiological Health, said in a Nov. 26 statement that the changes are due to rapid innovations being made in medical technology. The 510(k) pathway is the primary application process through which medical devices receive clearance.

"We're pursuing these changes to help keep pace with the increasing complexity of rapidly evolving technology," the statement said. "The new technology that we're seeing holds tremendous public health promise for patients. But with the advances also come new complexities that can make the review of safety and effectiveness more challenging."

Medical device makers have multiple pathways for the approval of their devices, but the 510(k) pathway is the most common. According to the FDA, 82% of all devices cleared or approved by the agency in 2017 went through this pathway.

The key aspect of the 510(k) process is what the FDA refers to as "substantial equivalence," meaning that medical device makers must prove that a device is substantially equivalent to a predicate device that has already been cleared or approved by the agency. If substantial equivalence can be demonstrated, the new device is considered to be of lesser risk, and the approval process is shorter and cheaper than other application pathways.

This substantial equivalence requirement is what could see stricter requirements in the future. Gottlieb and Shuren said the FDA may seek to require device makers to establish equivalence with devices that are 10 years old or newer. The FDA is also considering sunsetting older predicate devices, but this may require congressional approval, according to the statement.

"Older predicates might not closely reflect the modern technology embedded in new devices, or our more current understanding of device benefits and risks," the statement said.

Nearly 20% of medical devices that have been cleared through the 510(k) process are based on devices that are more than 10 years old, according to the FDA. The statement stressed that this change does not mean previous products are unsafe.

The Advanced Medical Technology Association, a trade association that represents medical technology companies, supported the FDA's pursuit for safety, but did not fully embrace the proposed 10-year cut-off.

"It is our hope that through the regulatory review, the agency will recognize that in some cases there are legitimate reasons for using older predicates," the organization said in a Nov. 26 statement. "The proposed 10-year cut off criteria could prove arbitrary as older predicates can offer extensive data about their performance, which helps sponsors introduce newer, safer devices."

Gottlieb and Shuren said the FDA may post a list of all devices that are based on predicate devices more than 10 years old on the Center for Devices and Radiological Health's website. The agency will seek public comment before posting this list, according to the statement.