Instructions for Completing Form 3500A (Specific to Medical Device Reporting)with Coding Manual for Form 3500A

摘要

The Food and Drug Administration (FDA), has established the final reportingrequirements for Device User Facilities and manufacturers under the revised Medical Device Reporting Regulation, 21 CFR, Part 803. The final reporting requirements for Distributors is contained in 21 CFR Part 804. These regulations enact a uniform system for the submission of reports of deaths, serious injuries and certain malfunctions associated with the use of medical devices. These reports must be submitted to the FDA and/or the manufacturer on FDA Form 3500A (MedWatch form). The FDA has developed this guidance document to assist User Facilities, Distributors and Manufacturers in complying with the requirements established in Parts 803 and 804 when completing applicable sections of Form 3500A. The Coding Manual for Form 3500A is also included, and it contains instructions for proper identification and utilization of the adverse event and manufacturer evaluation codes which must be provided when filling out certain sections of Form 3500A.