FDA Webview

Free FDA Notices

Participants Sought for MDR Malfunctions Pilot


Federal Register Notice: FDA is soliciting nominations for participation in a pilot program for submitting medical device reports for malfunctions of Class 1 devices and certain Class 2 devices in summary format on a quarterly basis. Under the Medical Device Reporting on Malfunctions pilot program, the agency intends to work with manufacturers to identify candidates for the pilot program and intends to continue to accept nominations until candidates for the pilot program have been selected. FDA will begin accepting nominations 9/1. To view this notice, click here.