• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

About FDA

  • Print
  • Share
  • E-mail

Does FDA regulate medical devices?

Yes, FDA regulates a broad range of medical devices, including complicated, high-risk medical devices, like artificial hearts, and relatively simple, low-risk devices, like tongue depressors, as well as devices that fall somewhere in between, like sutures. FDA has authority to regulate medical devices before and after they reach the marketplace.

 
-
Basics Question toggle Show all related FDA Basics Questions