FDA Refers Controversial Proposals to Revamp 510(k) Process to IOM

Devicemakers may have to wait several months longer to learn whether, or how, the FDA will implement a number of controversial suggestions for revamping the 510(k) process. The agency announced last week 25 proposals it will begin implementing as early as March, but it said it will refer the ones that drew “significant concern” in public comments to the Institute of Medicine (IOM), which is working on an independent review of the clearance process. IOM is expected to weigh in on the suggestions this summer.
Devices & Diagnostics Letter