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U.S. Department of Health and Human Services

For Industry

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Where can I get information on donor eligibility for human cells, tissues and cellular- and tissue-based products (HCT/Ps)?

Information on the requirements for donor eligibility for HCT/Ps may be found in FDA regulations, specifically 21 CFR 1271, subpart C.

FDA has also published guidance to assist establishments in making donor eligibility determinations under 21 CFR 1271, subpart C. The Guidance for Industry – Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products is posted on the web.

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