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  4. Recommendations to Reduce the Risk of Transmission of Mycobacterium tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
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GUIDANCE DOCUMENT

Recommendations to Reduce the Risk of Transmission of Mycobacterium tuberculosis (Mtb) 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-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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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-2024-D-3863.

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
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Food and Drug Administration
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