FDA Seeks to Make Covid-19 Device Shortage Reporting Permanent

Device companies would have to alert the FDA of potential shortages under a proposal to make permanent the agency’s temporary authorities granted to fight the Covid-19 pandemic.

Jeffrey E. Shuren, director of the Center for Devices and Radiological Health at the Food and Drug Administration, said Thursday that establishing a permanent device shortages program is one of several budget priorities he has for the center. Shortages in everything from the chemicals needed to run Covid-19 tests to the supplies, such as swabs, contributed to a testing crisis early in the pandemic that hamstrung the U.S. government’s ability to manage ...