Blood and Blood Products

The Center for Biologics Evaluation and Research (CBER) is responsible for the regulatory oversight of 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.^[1]

FDA Resources:

• Blood Guidances
• Blood Notices, Proposed and Final Rules

Updated by Peter Matos, December 2023