FDA Asks IOM to Evaluate 510(k) Clearance Process

A $1.3 million review of the 510(k) clearance process being conducted by the Institute of Medicine (IOM) at the FDA’s request to determine if improvements are needed to protect patients is playing to mixed reactions in the device industry. Industry association AdvaMed is taking a positive stance on the study, while other industry experts see the study leading to more regulation. Citing previous IOM studies, James Beck, a device liability lawyer with Dechert and co-author of the Drug and Device Law Blog, said it’s likely the organization will recommend that more devices go through a PMA review, which is more extensive than 510(k) clearance.
Devices & Diagnostics Letter