For all CDRH ODE and OIVD submissions: 510(k), IDE, PMA, 513(g), Pre-IDE and other lesser-submitted documents:
FDA Center for Devices and Radiological Health
Document Mail Center, HFZ-401
9200 Corporate Boulevard
Rockville, MD 20850
For all CDRH OC Registration and Listing submissions:
FDA Center for Devices and Radiological Health
Registration and Listing, HFZ-308
9200 Corporate Boulevard
Rockville, MD 20850
For all CDRH Medwatch submissions:
FDA Center for Devices and Radiological Health
Medical Device Reporting (Medwatch),
HFZ-535
9200 Corporate Boulevard
Rockville, MD 20850
For Small Business Determinations:
MDUFMA Small Business Qualification (HFZ-222)
Division of Small Manufacturers, International and Consumer Assistance (DSMICA)
1350 Piccard Drive
Rockville, MD 20850
For consumer questions or manufacturers assistance, please contact DSMICA at http://www.fda.gov/cdrh/devadvice/36f.html.
** Please use the list of addresses above for mailing any applications/submissions to CDRH.
Applications/submissions sent to any other address other then the ones listed below may result in a delay.
Updated August 24, 2006
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