Guidance for Industry: Recommendations for Donor Questioning, Deferral, Reentry and Product Management to Reduce the Risk of Transfusion-Transmitted Malaria

摘要

This guidance document provides you, blood establishments that collect blood and blood components, with our, FDAs, recommendations for questioning and deferring donors of blood and blood components, allowing their reentry, and product management to reduce the risk of transfusion-transmitted malaria. The recommendations contained in this guidance apply to the collection of Whole Blood and all blood components with the exception of Source Plasma.