Vaccines, Blood & Biologics

Premarket Approval (PMA) Process (CBER)

All CBER device applications should be addressed to:

Center for Biologics Evaluation and Research
Document Control Center
10903 New Hampshire Avenue
WO71, G112
Silver Spring, MD 20993-0002

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

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

Page Last Updated: 09/15/2014
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