MDR USER FACILITY ADVISORY PANEL BEING CONSIDERED BY FDA; AGENCY PLANS TO INSPECT SOME USER FACILITIES BUT HOPES MORE CAN BE REVIEWED BY OUTSIDE GROUPS
This article was originally published in The Gray Sheet
Executive Summary
FDA is considering establishing an advisory panel to assist in its implementation of medical device reporting requirements for user facilities, Larry Kessler, director of the Office of Surveillance and Biometrics in the Center for Devices and Radiological Health, said during a May 7 FDA teleconference focusing on the recently finalized MDR rules.