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  1. Development & Approval Process (CBER)

The Center for Biologics Evaluation and Research (CBER) regulates the medical devices involved in the collection, processing, testing, manufacture and administration of licensed blood, blood components and cellular products. CBER also regulates all HIV test kits used both to screen donor blood, blood components and cellular products, and to diagnose, treat and monitor persons with HIV and AIDs.

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})


Approval Process and Related Information

Approved Products

Device Guidances, Rules and Other Publications

Resources for You

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Contact Point
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3103
Silver Spring, MD 20993-0002

(800) 835-4709
(240) 402-8010

Hours Available

Food and Drug Administration
Food and Drug Administration
White Oak Campus

10903 New Hampshire Ave
Silver Spring, MD 20993
United States


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Contact Point Twitter

@fdacber

The latest information from the Center for Biologics Evaluation and Research.


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