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, ...
JSTOR Daily

Modern Theories of Higher Level Predicates: Second Intentions in the Neuzeit

Your institution does not have access to this book on JSTOR. Try searching on JSTOR for other items related to this book. https://doi.org/10.2307/j.ctv2x8v8kb.3 https ...
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 ...