FDA Policy/General

Guidance on HCT/P Donor Screening to Reduce Zika Virus

Federal Register Notice: FDA is making available 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. It provides establishments that make donor eligibility 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 8/2007. To download this guidance, click here. To view this notice, click here.

Guidance on HCT/P Donor Screening to Reduce Zika Virus

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