FDA Alternative Procedures for Blood and Blood Components During the COVID-19 Public Health Emergency
标准简介
Alternative Procedures for Blood and Blood Components During the COVID-19 Public Health Emergency[附网盘链接]是于之前发布的FDA标准，适用于US。标准截图
![Alternative Procedures for Blood and Blood Components During the COVID-19 Public Health Emergency[附网盘链接]](/img/20210914103551ahcvh.jpg)
标准文档说明
标准文档类型为Alternative Procedures for Blood and Blood Components During the COVID-19 Public Health Emergency[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
Alternative Procedures for Blood and Blood Components During the COVID-19 Public Health Emergency 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 The Food and Drug Administration (FDA or Agency) plays a critical role in protecting the United States (U.S.) from threats including emerging infectious diseases, such as the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic. FDA is issuing this guidance to provide a notice of exceptions and alternatives to certain requirements in Title 21 of the Code of Federal Regulations (CFR) regarding blood and blood components. This notice of exception or alternatives to certain requirements is being issued under 21 CFR 640.120(b) to respond to a national public health need and address the urgent and immediate need for blood and blood components. We expect that the alternative procedures will improve availability of blood and blood components while helping to ensure adequate protections for donor health and maintaining a safe blood supply for patients. The alternative procedures are intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services (HHS), including any renewals made by the Secretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act). FDA intends to provide further notification when the alternative procedures are no longer in effect. Given this public health emergency, and as discussed in the Notice published in the Federal Register of March 25, 2020, titled “Process for Making Available Guidance Documents Related to Coronavirus Disease 2019,” available at https://www.govinfo.gov/content/pkg/FR-2020-03-
25/pdf/2020-06222.pdf, this guidance is being implemented without prior public comment 1
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