Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis; Guidance for Industry; Availability

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The Food and Drug Administration is announcing the availability of a final guidance entitled "Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis." The final guidance document notifies blood establishments that collect blood and blood components that we have determined babesiosis to be a relevant transfusion-transmitted infection (RTTI) and provides recommendations for donor screening, donation testing, donor deferral, and product management to reduce the risk of transfusion-transmitted babesiosis (TTB). The recommendations contained in the guidance apply to the collection of blood and blood components, except Source Plasma. The guidance announced in this notice finalizes the draft guidance of the same title dated July 2018.