FDA’s Center for Devices and Radiological Health (CDRH), which oversees the safety and effectiveness of some 190,000 medical products, is taking what it calls “transformative new steps” to align its regulatory process with rapidly changing technology.
“Advances in material science, digital health, 3D printing and other technologies continue to drive an unparalleled period of invention in medical devices,” wrote FDA Commissioner Scott Gottlieb, MD, and CDRH Director Jeff Shuren, MD, Director of the Center for Devices and Radiological Health, in a statement published yesterday. “It’s vital that the FDA’s regulatory approach continue to evolve and modernize to safely and efficiently advance these opportunities. Not only must we keep pace with this complexity and innovation, but we must also stay ahead of the new and evolving risks that sometimes accompany this progress,” they added.
While the medical technology industry and its supply chain have often bickered with FDA, especially when it comes to what industry considers to be overly burdensome regulations, the agency is generally acknowledged to represent the gold standard globally in medical device oversight. The move to modernize the 510(k) pathway, by which medical device manufacturers of low- to moderate-risk devices can demonstrate substantial equivalence with a device currently on the market, is “aimed at efficiently advancing beneficial technology to patients while solidifying FDA’s gold standard for safety,” wrote Gottlieb and Shuren.
The core issue with the 510(k) as it stands is that manufacturers rely on comparative testing against legacy, or predicate, devices that can be decades old, said FDA. CDRH cleared more than 3000 devices in 2017 through the 510(k) program, and nearly 20% of current 510(k)s are based on a predicate that is more than 10 years old, according to the agency. Clearly, there have been considerable advances in technology and materials science during those years that are not being taken into account. “That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies,” said the statement.
To encourage device makers to rely on newer predicates, FDA is considering making public on its website cleared devices that demonstrated substantial equivalence to devices that are more than 10 years old as a “starting point.” Before moving forward, the agency will seek public feedback on whether it should name those devices or manufacturers, adopt other criteria or take alternative actions to promote the use of more modern predicates. FDA stresses that it does not believe that the devices in question are unsafe or should be removed from the market. “However, we believe that encouraging product developers to use more modern predicates . . . would help the overall product environment continue to evolve in the direction toward more modern performance standards,” writes the agency.