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U.S. Department of Health and Human Services

For Consumers

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Final Guidance: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products

FDA has issued final guidance, entitled "Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)," to assist establishments making donor eligibility determinations to comply with the requirements for determining donor-eligibility, including donor screening and testing for donors of human cells, tissues, and cellular and tissue-based products. (for background, see "New Rule and Draft Guidance Issued for Human Cell and Tissue Donor Screenings." The guidance applies to cells and tissues procured on or after the effective date of the regulations contained in 21 CFR part 1271, subpart C (effective date May 25, 2005). It does not replace the guidance concerning 21 CFR part 1270, entitled "Guidance for Industry: Screening and Testing of Donors of Human Tissue Intended for Transplantation," which remains applicable to tissues recovered before May 25, 2005, and subject to 21 CFR part 1270.

The document provides guidance on donor-eligibility determination, donor screenings, donor testing requirements (including HIV), additional screening and testing requirements for reproductive cells and tissues, and exceptions from the requirements for determining donor-eligibility, and special circumstances.

You can find the complete guidance document on the FDA web site.

Richard Klein
HIV/AIDS Program Director
Food and Drug Administration