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can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.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-3863
Docket Number: FDA-2024-D-3863 Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research
We, FDA, are issuing this guidance to assist you, establishments making donor eligibility (DE) determinations, in understanding the requirements in 21 CFR 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 provides recommendations for screening donors for evidence of, and risk factors for, infection with Mycobacterium tuberculosis (Mtb), the organism that causes tuberculosis. The guidance also recommends additional steps that HCT/P establishments should take to reduce risk of transmission of Mtb until such time as appropriate FDA-licensed, approved, or cleared donor screening tests are available for use to test donors for Mtb infection.
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Content current as of:
05/02/2025
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