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Medical Devices

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Home Health and Consumer Devices

FDA regulates medical devices that consumers use themselves without professional medical assistance in the same way as other medical devices.  But the agency also focuses on how average people can use these devices safely and effectively.

 

In addition to work done throughout the medical device approval process, the Home Health Care Committee reviews what has been done to address problems when devices are used in the home and recommends further actions to ensure consumers can use the devices safely and effectively.

 

Contact Us

  • CDRH-Division of Small Manufacturers, International and Consumer Assistance (DSMICA)

  • 1-800-638-2041
  • 301-847-8149 (Fax)
  • 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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