Donor Screening Recommendations To Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry; Availability

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled "Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry." The guidance document provides 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). The guidance identifies ZIKV as a relevant communicable disease agent or disease (RCDAD) and adds to recommendations contained in the guidance entitled "Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)" dated August 2007.