Recommendations for Donor Screening, Deferral, and Product Management To Reduce the Risk of Transfusion-Transmission of Zika Virus; Guidance for Industry; Availability

摘要

The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled "Recommendations for Donor Screening, Deferral, and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Virus: Guidance for Industry." The guidance document provides blood establishments that collect blood and blood components with recommendations for donor screening, donor deferral, and product management to reduce the risk of transfusion- transmitted Zika virus (ZIKV). The guidance applies to the collection of Whole Blood and blood components intended for transfusion. The guidance does not apply to the collection of Source Plasma.