Addresses for Submissions

For all CDRH ODE and OIVD submissions: 510(k), IDE, PMA, 513(g), Pre-IDE, PDP, HDE and CLIA:

U.S. Food and Drug Administration
Center for Devices and Radiological Health
Document Mail Center – WO66-G609
10903 New Hampshire Avenue
Silver Spring, MD  20993-0002

Deliveries are accepted between the hours of 8:00 to 4:30 EST.

For all CDRH OC Registration and Listing submissions:

U.S. Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance
Registration and Listing
10903 New Hampshire Avenue
WO66 Room 2621
Silver Spring, MD 20993-0002

For all CDRH MedWatch submissions:

Forms must be mailed to:

U.S. Food and Drug Administration
Center for Devices and Radiological Health
Medical Device Reporting
P.O. Box 3002
Rockville, MD 20847-3002

For carrier service deliveries:

U.S. Food and Drug Administration
Center for Devices and Radiological Health
Medical Device Reporting
16071 Industrial Drive, Room 258
Gaithersburg, Maryland 20877-1462

For Small Business Determinations:

MDUFMA Small Business Qualification
U.S. Food and Drug Administration
Center for Devices and Radiological Health
Division of Small Manufacturers, International and Consumer Assistance (DSMICA)
10903 New Hampshire Avenue
WO66 Room 4621
Silver Spring, MD 20993

For all Medical Device Export Certificate requests:

U.S. Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance
Export Certificates
10903 New Hampshire Avenue
WO66 Room 2621
Silver Spring, MD 20993-0002

For consumer questions or manufacturers assistance, please contact DSMICA.