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U.S. Department of Health and Human Services

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 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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