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# FDA Withdraws and Reissues 2 Guidances
- URL: https://www.fdaweb.com/fda-withdraws-and-reissues-2-guidances/
- Published: 2025-05-02T12:00:00.000Z
- Updated: 2026-09-14T15:10:56.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5159111

FDA says it is withdrawing two recent final guidances on cell- and tissue-based products and reissuing them in draft form that makes modifications based on undisclosed comments made by stakeholders. The guidances are “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)” and “Recommendations To Reduce the Risk of Transmission of Mycobacterium Tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps),” according to an FDA [notice](https://public-inspection.federalregister.gov/2025-07752.pdf?ref=fdaweb.com).

The first draft guidance is intended to provide establishments making donor eligibility determinations with recommendations to reduce the risk of transmission of disease agents associated with sepsis for donors of human cells, tissues, and cellular and tissue-based products. The second guidance is intended to assist establishments that make donor eligibility determinations for donors of human cells, tissues, and cellular and tissue-based products, with recommendations for screening donors for evidence of, and risk factors for, infection with Mtb, the organism that causes tuberculosis.