A Stanford Law School Center for the Law and Biosciences fellow says policymakers should consider the growth in breakthrough medical devices cleared through the 510(k) pathway when evaluating FDA’s need for more staff and resources directed to device recall oversight.

FDA faces renewed scrutiny of an internal FDA analysis of pediatric deaths reported after Covid-19 vaccination, following the release of documents by Senator Ron Johnson (R-WI) that he says show federal health officials failed to fully disclose vaccine safety concerns.