Medical Device Reports Procedure

The medical device reports procedure defines the process used to make Medical Device Reports (MDRs) to the FDA. The procedure applies to all devices marketed in the United States unless excluded by FDA regulations.The process to determine if a product was associated with or caused a reportable event requires completing an MDR decision tree (included) with the procedure. Instruction on MDR processing, including electronic submission options, is included. Also included is instruction on MDR number assignment and supplemental reports. The medical device reports procedure complies with 21 CFR Part 803 and FDA QSR.