🩸FDA Draft Guidance on Reducing Transfusion-Transmitted Malaria Risk
Recommendations To Reduce the Risk of Transfusion-Transmitted Malaria; Draft Guidance for Industry; Availability
Summary
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft document entitled "Recommendations To Reduce the Risk of Transfusion-Transmitted Malaria." The draft guidance document provides blood establishments that collect blood and blood components with FDA's revised recommendations to reduce the risk of transfusion-transmitted malaria (TTM). The guidance recommends selectively testing blood donations from donors at risk for malaria using an FDA-licensed donor screening nucleic acid test (NAT) for Plasmodium species (spp.), the causative agents of malaria. The draft guidance, when finalized, is intended to supersede the document entitled "Recommendations To Reduce the Risk of Transfusion-Transmitted Malaria," dated December 2022.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The draft guidance outlines compliance recommendations for blood establishments to mitigate transfusion-transmitted malaria risks, affecting operational protocols and testing requirements. Businesses must adapt to these revised guidelines to ensure compliance, impacting operational costs and processes.