What is the Safe Medical Device Act?

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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.

FAQs

What medical devices are defined by the Safe Medical Devices Act?

Except for medicines, the Safe Medical Devices Act of 1990 defines a medical device as any equipment, apparatus, or other thing used to prevent, diagnose, mitigate, or treat a disease that affects the structure or function of the body.

*Source: https://www.stjoeshealth.org

What are the objectives of SMDA?

The SMDA’s primary goals are to:

  • Ensure medical devices placed on the market are safe and effective
  • Accelerate reporting of adverse events to the U.S. Food and Drug Administration (FDA)
  • Remove defective products from the marketplace

*Source: https://pubmed.ncbi.nlm.nih.gov/10125364/

What are the manufacturer's responsibilities under the Safe Medical Devices Act?

Under the SMDA, medical device manufacturers must:

  • Report any adverse event associated with the product to the FDA
  • Submit medical device reporting (MDR) paperwork to the FDA upon learning of an adverse event
  • Submit baseline and 30-day reports of deaths, serious injuries, and malfunctions associated with the device to the FDA

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