We, FDA or Agency, are issuing this guidance to assist you, establishments making donor eligibility determinations,  in understanding the requirements in Title 21 Code of Federal Regulations, 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, or cellular or tissue-based products (HCT/Ps).  

This guidance applies to human cells and tissues recovered on or after May 25, 2005, the effective date of the regulations contained in 21 CFR part 1271, subpart C, and provides recommendations to reduce the risk of transmission of human immunodeficiency virus (HIV) by HCT/Ps.  This guidance updates information regarding HIV risk included in the guidance entitled “Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), Guidance for Industry,” dated August 2007 (August 2007 HCT/P DE Guidance), by revising recommendations for:  1) donor screening that includes reducing certain time-based risk factors and conditions; 2) assessing every HCT/P donor for HIV risk using the same individual risk-based questions regardless of sex or gender; and 3) use of an FDA-licensed donor screening test that includes detection of anti-HIV-1 group O and removing the recommendation to screen HCT/P donors for HIV-1 group O risk.

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