Device Application Submissions

All CBER device applications should be addressed to:

FDA/CBER
1401 Rockville Pike
HFM-99, Room 200N
Rockville, MD 20852-1448

(Please do not send CBER device applications to the Center for Devices and Radiological Health {CDRH})

Useful Information:

• How to Prepare a Traditional 510(k)
• Information on Premarket Approval Applications
• Premarket Approval - How to Market a PMA Medical Device

CBER Information

Useful Government Sites