Safe Medical Devices Act (SMDA)

What is the Safe Medical Devices Act (SMDA)?

The Safe Medical Devices Act (SMDA) of 1990 is a federal law in the United States that requires facilities that use medical devices to report any death, serious illness, or injury associated with a device to the Food and Drug Administration (FDA) and manufacturer. It was designed to protect the public by ensuring that medical devices are not unsafe for their intended use and to give the FDA more authority to track and monitor medical devices already on the market.

The SMDA established several important provisions:

  • Manufacturer reporting requirements: The act mandates medical device manufacturers to report any adverse events or product malfunctions to the FDA. This includes incidents that result in serious injury or death caused by the use of a medical device.
  • User facility reporting requirements: Healthcare facilities, such as hospitals or nursing homes, are also required to report incidents involving medical devices to the FDA.
  • Post-market surveillance: The act expanded the FDA’s authority to monitor medical devices after they have been approved or cleared for marketing. This allows for better detection of potential safety issues that may arise once a device is in widespread use.

How does the SMDA improve healthcare?

The primary objectives of the SMDA are to accelerate the reporting of adverse events to the FDA, ensure that only safe and effective medical devices are on the market, and rapidly remove defective products from the marketplace. Overall, the SMDA aims to enhance the FDA’s oversight of medical devices and improve the flow of information regarding device safety and performance, ultimately ensuring greater protection for patients. Furthermore, all SMDA reports submitted to the FDA are added to its medical device reporting database, allowing for quick access to details on all reported adverse events.