Food and Drug Administration (FDA) – Recommendations to reduce the risk of transmission of mycobacterium tuberculosis (Mtb) by human cells, tissues, and cellular and tissue-based products (HCT/Ps)
FDA has issued a guidance to provide recommendations for making donor eligibility (DE) determinations, in line with 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 DE, 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.
News reported on the 31st of January 2025 in Catapult’s regulatory round-up, read the entire report here.
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adelage (20 mai 2025). Food and Drug Administration (FDA) – Recommendations to reduce the risk of transmission of mycobacterium tuberculosis (Mtb) by human cells, tissues, and cellular and tissue-based products (HCT/Ps). ELSIBI. Consulté le 18 janvier 2026 à l’adresse https://doi.org/10.58079/13yex





