Submit Comments by 07/07/2025
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.
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-2024-D-3067
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 updates information regarding sepsis included in the guidance entitled “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), and when finalized, will update recommendations for making a donor eligibility determination when screening a donor for clinical evidence of sepsis and clinical signs to consider.
Questions?
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Content current as of:
05/02/2025
