Issue Date: August 20, 2021
Issued by: Center for Biologics Evaluation and Research
Topic(s): Application & Approvals, Blood Products
Status: Final
Notifying FDA of Fatalities Related to Blood Collection or Transfusion: Guidance for Industry
This document’s goal is to help you, a blood collection or transfusion facility, report fatalities related to blood and blood component (blood) collection or transfusion to us, the Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER). This guidance updates the guidance of the same title dated September 2003. The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract. This document is intended only to provide clarity to the public regarding existing requirements under the law. FDA guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.
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