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FDA's Role in Regulating Medical Devices

FDA regulates the sale of medical device products (including diagnostic tests) in the U.S. and monitors the safety of all regulated medical products.

In the U.S., FDA regulates the sale of medical device products. Before a medical device can be legally sold in the U.S., the person or company that wants to sell the device must seek approval from the FDA. To gain approval, they must present evidence that the device is reasonably safe and effective for a particular use.

The FDA does not have the authority to:

  • Regulate a physician's or nurse's practice.  FDA does not tell providers what to do when running their business or what they can or cannot tell their patients.
  • Make recommendations for individual doctors, clinics, or home care agencies.
  • Conduct or provide a rating system on any regulated medical devices.

FDA monitors the ongoing safety and efficacy of regulated marketed devices through MedWatch, the FDA  Safety Information and Adverse Event Reporting Program.  MedWatch allows manufacturers, health care professionals and consumers to report serious problems related to the use of drugs and medical devices. 

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