QS & the FDA: DSMICA
The Division of Small Manufacturers, International and Consumer Assistance (DSMICA) provides technical and regulatory assistance to small manufacturers to help them comply with Food and Drug Administration (FDA) requirements for medical devices.
- Please include your e-mail address, telephone and fax numbers if you desire a response.
CDRH/OCER/DSMICA (HFZ-220)
1350 Piccard Drive
Rockville, MD 20850-4307E-mail: dsmica@fda.hhs.gov or industry.devices@fda.hhs.gov
Telephone Numbers: 301-796-7100 or 800-638-2041
Fax Number: 240-276-3151