Safe Medical Devices Act of 1990: current hospital requirements and recommended actions.

Abstract

Since the Safe Medical Devices Act of 1990 was signed into law, a great deal of confusion has surrounded it. This document reviews the current status of user reporting and device tracing--including the MEDWatch program--and the status of the final regulations. In addition, readers will learn what it all really means for hospitals and what incidents must now be reported to the FDA.