This guidance provides you, establishments that make donor eligibility (DE) determinations for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps), with recommendations for screening donors for evidence of, and risk factors for, infection with Zika virus (ZIKV). This guidance identifies ZIKV as a relevant communicable disease agent or disease (RCDAD) as defined in 21 CFR Part 1271. This guidance supplements the recommendations contained in the guidance titled “Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)” dated August 2007.


Posted on the FDA website on 3 March 2016