The Center for Biologics Evaluation and Research (CBER) regulates the collection of blood and blood components used for transfusion or for the manufacture of pharmaceuticals derived from blood and blood components, such as clotting factors, and establishes standards for the products themselves. CBER also regulates related products such as cell separation devices, blood collection containers and HIV screening tests that are used to prepare blood products or to ensure the safety of the blood supply. CBER develops and enforces quality standards, 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 identify and respond to potential threats to blood safety, to develop safety and technical standards, to monitor blood supplies and to help industry promote an adequate supply of blood and blood products.
Over a period of years, FDA has progressively strengthened the overlapping safeguards that protect patients from unsuitable blood and blood products:
- Blood donors are now asked specific and very direct questions about risk factors that could indicate possible infection with a transmissible disease. This "up-front" screening eliminates approximately 90 percent of unsuitable donors.
- FDA requires blood centers to maintain lists of unsuitable donors to prevent the use of collections from them.
- Blood donations are tested for seven different infectious agents.
In addition to strengthening these safeguards, FDA has significantly increased its oversight of the blood industry:
- FDA inspects all blood facilities at least every two years, and "problem" facilities are inspected more often.
- Blood establishments are now held to quality standards comparable to those expected of pharmaceutical manufacturers.
While a blood supply with zero risk of transmitting infectious disease may not be possible, the blood supply is safer than it has ever been. As biological products, blood and blood products are likely always to carry an inherent risk of infectious agents. Therefore, zero risk may be unattainable. The role of FDA is to drive that risk to the lowest level reasonably achievable without unduly decreasing the availability of this life saving resource.
Forms and Regulatory Information
Product Listings and Related Information
- AABB and PPTA Donor History Questionnaires
Biologics Products & Establishments
BLAs, NDAs, PMAs, 510(k)s
510(k) Blood Establishment Computer Software Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 Immune Globulin Intravenous (IGIV) Indications Variances for Collection of Blood and Blood Products from Patients with Hemochromatosis