FDA Plans to Modernize 510(k) - Is the Sky Falling?

Have you heard the news? FDA caused quite a stir when it recently announced transformative changes that will modernize its 510(k) program to improve the safety and effectiveness of medical devices. But as we all know, the more things change, the more they stay the same. If you dive deep into FDA’s statement, you’ll realize that there’s probably not a lot that’s different. In this episode, Mike Drues, of Vascular Sciences, and I offer an initial reaction to these changes. Some of the highlights of the show include: ● 10-Year Rule: Policy that a 510(k) can’t use a predicate that’s greater than 10 years old. ● Root cause for this policy may be due to recent news of medical devices gone bad and the challenge of predicate creep with 510(k)s. ● Regulation states that to have a successful 510(k), you need a predicate; it doesn’t state a limitation for the age of the predicate. ● It should be up to the medical device professional to decide which predicate would be the best to use - no matter if it’s 1, 10, or 40 years old. ● Twenty percent of 510(k)s reference a predicate greater than 10 years old. This is a solution for 20%, not the other 80%. ● There’s been past movements for alternative and abbreviated 510(k) pathways. So, nothing really new or revolutionary with FDA’s statement. ● FDA wants manufacturers to develop newer and better technologies than what’s currently available. But should “better” be a part of a 510(k)? It’s an oxymoron. ● If new device increases or creates new risks than a predicate, can’t be a 510(k) - but this is not usually enforced and de novos are sometimes pursued.