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Center for Biologics Evaluation and Research, U.S. Food and Drug AdministrationU.S. Food and Drug AdministrationCenter for Biologics Evaluation and Research
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CBER links
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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. CBER has developed a Device Action Plan to facilitate the device provisions of the 1997 Food and Drug Administration Modernization Act and to ensure consistency between the policies and procedures of CBER and FDA's Center for Devices and Radiological Health.



Device Action Plan

Devices Regulated by CBER



Application Submission

Blood Estab Computer Software

HIV, HTLV & Hepatitis Tests

Frequently Asked Questions About the OraQuick Rapid HIV-1 Antibody Test

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