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.
I’m going to go out on a limb here and suggest that FDA might get some push back from industry on part of its proposal. Naming manufacturers who received clearance based on an older predicate device does ring of public shaming, which is wholly unfair since they did nothing wrong and dutifully followed the rules of the 510(k) program.
Commenting on the initiative, industry lobbying group Advamed recognized the need for regulatory systems to evolve and keep pace with innovation and said that it looked forward to working with the agency and other stakeholders on the modernization program. “It is important, however, that FDA move forward carefully and thoughtfully to ensure the new policy does not arbitrarily or inadvertently prevent the use of older predicates where the clinical and scientific information remains valid," said Advamed.
FDA intends to finalize guidance on an alternative 510(k) pathway that prioritizes the use of more modern criteria in early 2019 and plans to name the new approach the Safety and Performance Based Pathway. “Through this new path, a company would demonstrate that a novel device meets modern performance-based criteria that have been established or recognized by the FDA and reflect current technological principles. These criteria would reflect the safety and performance of modern predicate devices,” writes the agency.
In announcing this proposal, FDA also posted a performance report on its website that highlights some of its key achievements in the past decade. It also noted that “additional changes are needed to fully modernize the 510(k) program” that may require support from Congress.
It has not escaped notice that the statement came a day after the publication in various media outlets of the results of a yearlong global investigation into the safety of medical implants. The massive undertaking involved more than 250 reporters who analyzed a decade’s worth of FDA data. FDA has collected 5.4 million “adverse event” reports over the past decade, some from manufacturers reporting problems in other parts of the world," reported the Guardian, one of the media outlets that published results from the Implant Files investigation. “These included 1.7 million reports of injuries and almost 83,000 deaths. Nearly 500,000 mentioned an explant—surgery to remove a device.”