FDA | Biologics Effectiveness and Safety (BEST)

Blood & Blood Products

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.

Most Recent Blood & Blood Products Assessments



COVID-19 Convalescent Plasma Surveillance Protocol

C19 Plasma Protocol 2021 (pdf)


COVID-19 Convalescent Plasma Surveillance Protocol

Advancing the Use of the ISBT-128 Coding System in Electronic Health Records to Monitor Blood Transfusion Prevalence in the United States

ISBT codes characterize transfusion rates Abstract 2018 (pdf)


ISBT 128, Information Standard for Blood and Transplant 128 Coding System, Transfusion, Blood, Whole Blood, Blood Components, transfusion related adverse events, AE, EHR, Electronic Health Records, Red Blood Cells, Platelets, Plasma, Cryoprecipitate