USA – 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 the less stringent US Food and Drug Administration (FDA) review pathway, an industry expert says.

The studies – Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance, and Use of Recalled Devices in New Device Authorizations Under the US Food and Drug Administration’s 510(k) Pathway and Risk of Subsequent Recalls – were published in the JAMA on 10 January.

The two papers question the adequacy of the popular device review pathway. Most devices – more than 3,000 a year – enter the US market as 510(k)s, which means they were shown to be substantially equivalent to already-authorized and marketed products…