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GUIDANCE DOCUMENT

An Acceptable Circular of Information for the Use of Human Blood and Blood Components Guidance for Industry September 2024

Download the Final Guidance Document
Final Level 2 Guidance
Docket Number:
FDA-2002-D-0223
Issued by:
Guidance Issuing Office
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 June 2024 (June 2024 Circular).  The June 2024 Circular provides specific labeling instructions for the administration and use of blood and blood components intended for transfusion.  We believe that the June 2024 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 March 2022.

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2002-D-0223.

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010
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