FDA/CBER is responsible for regulatory oversight of the U.S. blood supply. FDA promulgates and enforces standards for blood collection and for the manufacturing of blood products, including both transfusible components of whole blood, pharmaceuticals derived from blood cells or plasma, and related medical devices. FDA also inspects blood establishments and monitors reports of errors, accidents and adverse clinical events. CBER works closely with other parts of the Public Health Service (PHS) to establish blood standards, and to identify and respond to potential threats to blood safety or supply.

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Key Resources

• Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products - Questions and Answers
• Keeping Blood Transfusions Safe: FDA's Multi-layered Protections for Donated Blood
• Exceptions and Alternative Procedures Approved Under 21 CFR 640.120
• Review Checklist