FDA Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products
标准简介
Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products[附网盘链接]由FDA于不久前发布，适用于US。标准截图
![Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products[附网盘链接]](/img/202109141037241iwon.jpg)
标准文档说明
标准文档类型为Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
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 This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page. I. INTRODUCTION 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 updates and supersedes the guidance of the same title dated March 2016 which identified ZIKV as a relevant communicable disease agent or disease (RCDAD) as defined in 21 CFR Part 1271. This guidance also 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. This guidance updates information in the March 2016 guidance by: 1) providing findings from more recent epidemiological studies including impact on public health; 2) reporting new data that informs the potential for transmission of ZIKV; 3) discussing the current status of availability of ZIKV tests; 4) updating sexual contact risk factors; 5) updating when an area is considered to have an increased risk for ZIKV transmission; and, 6) providing additional scientific references. This update supports the continuation of recommendations to screen living donors of HCT/Ps for risks of infection with ZIKV based on geographic areas with risk. FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA’s guidances means that something is suggested or recommended, but not required.
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