The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has published its FY2023 guidance priority lists. Much of the center’s focus in the current fiscal year is ...
Michelle Tarver directs the Food and Drug Administration’s medical device center, which oversees everything from pacemakers to the latest AI-enabled medical products. Tarver, both an epidemiologist ...
The U.S. FDA’s device center has at times struggled to make the volume of hires under the reigning Medical Device User Fee Agreement (MDUFA), but that wasn’t a problem in fiscal year 2023.