FDA Plans to ‘Retire’ Outdated 510(k) Predicates
FDA says it is examining ways to modernize the medical device 510(k) process by relying more on a review that weighs new technologies that improve device safety or performance and to “retire” outdated predicate devices that have been cited to demonstrate equivalence, “especially in cases where we’ve seen safer or more effective technology emerge.” A new joint statement from CDRH director Jeff Shuren and FDA commissioner Scott Gottlieb says that new efforts being considered are aimed at “adopting a more modern process that allows the FDA to more readily incorporate new technologies that improve the safety and performance of medical devices into new predicates to serve as benchmarks for future clearances.”
The FDA officials say it is time to move away from relying on comparative testing against predicate devices to demonstrate that a new device is as safe and effective as the predicate. “Older predicates might not closely reflect the modern technology embedded in new devices, or our more current understanding of device benefits and risks,” they say. “In some cases, the predicate could be decades old. Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. 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.”
Shuren and Gottlieb believe that newer devices should be compared to the benefits and risks of more modern technology, and they want stakeholder comments on new ways FDA can promote using more recent predicates. One idea under consideration is a public shaming campaign where the agency will post on its Web site a listing of devices cleared by relying on older predicate devices. “We’re considering focusing on predicates that are more than 10 years old as a starting point, so that the public is aware of those technologies. Our goal in focusing on older predicates is to drive sponsors to continually offer patients devices with the latest improvements and advances.”
Before posting the list, FDA will seek public feedback on whether “we should make public those devices or those manufacturers who make technologies that rely on predicates that are more than 10 years old, whether other criteria should inform our point of reference, and whether there are other actions we should take to promote the use of more modern predicates,” write Shuren and Gottlieb. They say that encouraging product developers to “use more modern predicates would give patients and their doctors a choice among older and newer versions of a type of device, promote greater competition to adopt modern features that improve safety and performance, and help make sure that newer devices reflect more modern technology and standards that can improve patient care and outcomes. It would help the overall product environment continue to evolve in the direction toward more modern performance standards.”
Shuren and Gottlieb also say that early next year, FDA intends to issue a guidance allowing an alternative 510(k) pathway where manufacturers of certain well-understood device types can “rely on objective safety and performance criteria to demonstrate substantial equivalence as a way to make it more efficient to adopt modern criteria as the basis for the predicates that are used to support new products. Our goal in finalizing this pathway that we discussed in our Medical Device Safety Action Plan is to expand its use broadly across the 510(k) program and make it the primary pathway for devices eligible for 510(k) review... Sometimes, by relying on old predicates, it can actually make it more difficult for more advanced technology to reach patients since it’s harder for an innovative product to bridge to an outdated technology reflected in a decades-old predicate. Our new proposed approach enables us to help improve safety and performance, as appropriate, and ensure new products can more easily reflect beneficial new advances.”
Under the new “Safety and Performance Based Pathway” a company would demonstrate that a novel device meets current performance-based criteria that have been established or recognized by the agency and reflect current technological principles. “We’d like this efficient new pathway to eventually supplant the practice of manufacturers comparing their new device technologically to a specific, and sometimes old, predicate device,” the officials say.
Additional changes are under discussion to revamp 510(k) program, Shuren and Gottlieb note, such as a more streamlined process to implement FDA-mandated “new special controls to address safety concerns more quickly, as well as to up-classify a device type, where appropriate, in response to a safety concern... As a result of our 510(k) policy proposals, we also believe that more devices will use the De Novo pathway, which permits a robust evaluation of novel devices and allows the FDA to establish special controls for devices of the same type. In the next few weeks, we plan to issue a proposed rule clarifying procedures and requirements for submissions of De Novo requests, further advancing our efforts to establish a regulatory framework that sets clear standards, expectations and processes for De Novo classification as a way to continue to modernize the 510(k) process.”
To read about other recent changes to the 510(k) program, click here.