An Acceptable Circular of Information for the Use of Human Blood and Blood Components Guidance for Industry March 2022

GUIDANCE DOCUMENT

• Docket Number: FDA-2002-D-0223
• Issued by: Center for Biologics Evaluation and Research

We, the Food and Drug Administration (FDA), Center for Biologics Evaluation and Research, are recognizing as acceptable for use by you, manufacturers of blood and blood components intended for transfusion, the document entitled “Circular of Information for the Use of Human Blood and Blood Components,” dated December 2021 (December 2021 Circular).  The December 2021 Circular provides specific labeling instructions for the administration and use of blood and blood components intended for transfusion.  We believe that the December 2021 Circular will assist you in complying with labeling requirements under 21 CFR 606.122.  The requirements under 21 CFR 606.122 specify that a circular of information must be available for distribution with blood and blood components intended for transfusion.  Section 606.122 further specifies the information that is required in the circular of information.  This guidance supersedes the guidance of the same title updated December 2017

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