Health and Human Services Department Docket FDA-2000-D-0187 Notice

2022-26711: Recommendations To Reduce the Risk of Transfusion-Transmitted Malaria; Guidance for Industry; Availability

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Summary

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance entitled "Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria." The guidance document provides 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 the guidance apply to the collection of Whole Blood and blood components, except Source Plasma. The guidance announced in this notice supersedes the guidance entitled "Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria; Guidance for Industry" dated April 2020.

The agency’s own summary, as published.

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