Medical Devices

Device Advice: Device Regulation and Guidance

Information for regulated industry on determining how to comply with the federal laws and regulations governing medical devices.

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