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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Premarket Approval (PMA) Process (CBER)

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)

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448
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