FDA Releases New Draft Guidance Documents To Modernize The 510(k) Process

On September 6, 2023, the FDA released three draft guidance documents that seek to "modernize" the 510(k) premarket notification process. Ever since the FDA first proposed "transformative new steps" to the program in 2018, the agency has promised to further update the 510(k) clearance pathway in an effort to better balance technological innovation and patient safety. In issuing these draft guidance documents, the FDA has followed through on that promise.

The first document, Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission, outlines four best practices that 510(k) submitters should follow when choosing a predicate device. First, the predicate device should have been cleared by "well-established methods," such as an FDA-recognized voluntary consensus standard. Second, the predicate device should "meet or exceed expected safety and performance," requiring submitters to continually be on the lookout for