JD Supra

Modernizing the FDA’s 510(k) Program for Medical Devices: Selection of Predicate Devices and Use of Clinical Data in 510(k) Submissions

On September 6, 2023, the US Food and Drug Administration (FDA) released a trio of draft guidances in its efforts to “strengthen and modernize” the 510(k) Program and provide for more “predictability, ...
RAPS

FDA’s Proposal to Limit Device Predicates Fails to Garner Industry Support

The medical device industry is criticizing a US Food and Drug Administration (FDA) proposal to limit the use of older predicate devices, citing misconceptions about the 510(k) pathway, hindered market ...