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U.S. Department of Health and Human Services

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 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.

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Contact FDA

1-800-638-2041
301-796-7100
Fax:301-847-8149
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

WO66-4621

Silver Spring, MD 20993
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