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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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510(k) 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:

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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Device Guidances, Rules and Other Publications

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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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