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Medical Devices

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Consumer Products

Medical devices consumers use on their own to solve health issues and improve quality of life. 

Because these products don't require a health professional for every use, however, the FDA requires clear, plainly written instructions and other safeguards to ensure safety and effectiveness.  Risks such as infection or injury still exist with these products and everyone--FDA, the health professionals that prescribe some of the products, and consumers--have a role to play in prevention.

 

 

 

Contact Us

  • 1-800-638-2041
  • 301-847-8149 (Fax)
  • CDRH-Division of Small Manufacturers, International and Consumer Assistance (DSMICA)

    Office of Communication, Education and Radiation Programs

    Center for Devices and Radiological Health

    Food and Drug Administration

    10903 New Hampshire Avenue

    WO66-4613

    Silver Spring, MD 20993

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