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GUIDANCE DOCUMENT

Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Guidance for Industry January 2025

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2024-D-3067
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

We, FDA, are issuing this guidance to assist you, establishments making donor eligibility determinations,  in understanding the requirements in Title 21 Code of Federal Regulations, part 1271, subpart C (21 CFR part 1271, subpart C).  The regulations under 21 CFR part 1271, subpart C, set out requirements for determining donor eligibility, including donor screening and testing, for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps).  This guidance supersedes information regarding sepsis included in the guidance “Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), Guidance for Industry,” dated August 2007 (August 2007 HCT/P DE Guidance), by updating recommendations for making a donor eligibility determination when screening a donor for clinical evidence of sepsis and clinical signs to consider. 
 

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5630 Fishers Lane, Rm 1061
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All written comments should be identified with this document's docket number: FDA-2024-D-3067.

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Contact Point
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