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.
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 Variances for Collection of Blood and Blood Products from Patients with Hemochromatosis Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 Review Checklist