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)
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Key Resources
Premarket Approvals (PMAs)
CBER Premarket ApprovalsPMA Approvals
CDRH Premarket ApprovalsHow to Market Your Device
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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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