This revised guidance document provides you, blood establishments that collect blood and blood components, with FDA's recommendations to reduce the risk of transfusion-transmitted malaria (TTM). The recommendations contained in this guidance apply to the collection of Whole Blood and blood components, except Source Plasma. Blood establishments are not required to assess Source Plasma donors for malaria risk (see 21 CFR 630.15(b)(8)). This guidance supersedes the guidance dated August 2013 and updated August 2014, entitled, "Recommendations for Donor Questioning, Deferral, Reentry and Product Management to Reduce the Risk of Transfusion-Transmitted Malaria" (Notice of Availability, 78 FR 50421 (August 19, 2013)).
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