Safe Medical Device Act Definition
The Safe Medical Devices Act (SMDA) of 1990 is a federal law that requires medical device manufacturers and user facilities (i.e., hospitals and ambulatory surgical facilities) to report any adverse events associated with a medical device to the U.S. Food and Drug Administration (FDA). It provides the FDA with two additional post-market activities—post-market surveillance for the monitoring of products after their clearance to market and device tracking for maintaining traceability of certain devices to the user level. Under the SMDA, it is mandatory for user facilities, manufacturers, and importers to submit medical device reporting (MDR) paperwork to the FDA after they become aware of a serious event associated with the device. Manufacturers are also required to submit baseline reports and 30-day reports of deaths, serious injuries, and malfunctions associated with the device to the FDA.