Capitol Correspondence - 11.26.18

Just in: FDA proposing major modernization of device approvals

Share this page

ANCOR is sharing this article by Politico Pro because of the potential this issue could have to carry over to the use of technology in I/DD supports.

FDA [Food and Drug Administration] is planning to modernize the most commonly used medical device approval pathway to ensure that new devices account for advances in technology while relying on modern safety and performance criteria.

The proposed changes to the 510(k) pathway, which was established back in 1976, would affect just over 80 percent of the devices reviewed by FDA. Low-to-moderate-risk devices can gain FDA approval through this pathway by showing they are substantially equivalent to a medical device already on the market — what’s known as a predicate device. More than 3,000 devices were approved via this approach in 2017.

FDA is looking at major changes to what companies can rely on as predicate devices — and the agency aims to eventually replace the predicate system altogether. That’s because devices being reviewed under the 510(k) program are more and more complex, and include technologies that are different than the predicates on which they’re based, FDA Commissioner Scott Gottlieb and device center head Jeffrey Shuren said in a joint statement early today. For instance, new devices use more automation, robotics and advanced materials. And interconnectedness and interoperability create new cybersecurity threats.

The agency wants to retire outdated predicate devices, particularity if safer or more effective technology exists, and have companies compare new device applications to more modern predicates. FDA is considering using 10 years as a cutoff point and encouraging new 510(k) applications to compare themselves to products less than 10 years old. It is working on proposals that would potentially sunset certain older predicates.

FDA is also working on a guidance for early 2019 that would establish an alternative 510(k) pathway that would let manufacturers of certain well-understood device types rely on objective safety and performance criteria to demonstrate substantial equivalence, rather than relying on a predicate. This approach would be called the “Safety and Performance Based Pathway,” and companies would show a new device meets criteria established by FDA. The agency hopes this pathway could eventually replace the practice of comparing new devices to a specific and sometimes older medical one.