Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components; Guidance for Industry; Availability

摘要

The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled "Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components; Guidance for Industry." The guidance document is notifying blood establishments that collect Whole Blood and blood components, that FDA has determined Zika virus (ZIKV) to be a relevant transfusion- transmitted infection (RTTI) and provides FDA's assessment. The guidance also provides recommendations to reduce the risk of transmission of ZIKV by Whole Blood and blood components. The guidance applies to the collection of Whole Blood and blood components. The guidance does not apply to the collection of Source Plasma. The guidance supersedes the February 2016 document entitled, "Recommendations for Donor Screening, Deferral, and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Virus: Guidance for Industry" (February 2016 guidance), and the March 2016 document entitled, "Questions and Answers Regarding `Recommendations for Donor Screening, Deferral, and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Virus: Guidance for Industry'