Medical Devices
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.
Recalls & Alerts
Contact Us
CDRH-Division of Small Manufacturers, International and Consumer Assistance (DSMICA)
- 1-800-638-2041
- 301-847-8149 (Fax)
- dsmica@fda.hhs.gov
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

