RAPS

Expert: Studies linking recalled 510(k) devices to problematic predicate products are ‘warning shot’ for manufacturers

Two recent studies that link the recall of 510(k)-cleared medical devices to problematic predicate products should serve as a “shot across the bow” for companies as they develop new devices headed for ...
JD Supra

FDA fills 510(k) guidance gaps with drafts on predicate devices, clinical data, implantables

The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) has issued three new draft guidances as part of an effort to modernize its 510(k) Program for new products ...
TCTMD

Medical Devices Cleared on Faulty Predicates More Likely to be Recalled

There is a troubling loophole in the US Food and Drug Administration’s 510(k) pathway that allows for the approval of medical devices that are at a higher risk of recall, according to results of two ...
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, ...