Medical Device Reporting for User Facilities

Course overview

he Safe Medical Devices Act of 1990 (SMDA) imposed significant new reporting require-ments on the medical device industry and users of medical devices. SMDA requires user facilities to report device-related deaths and serious injuries to the Food and Drug Administra-tion (FDA) and/or the manufacturer. Although the user facility reporting requirements of SMDA were automatically effective November 28, 1991, this guidance document is based on the final Medical Device Reporting (MDR) rule which was published in the December 11, 1995, Federal Register. The final rule also addresses changes mandated by the Medical Device Amendments of 1992.