Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria Draft Guidance for Industry January 2025

GUIDANCE DOCUMENT

• Docket Number: FDA-2000-D-0187
• Issued by: Center for Biologics Evaluation and Research

This guidance document provides you, blood establishments that collect blood and blood components, with FDA’s revised recommendations to reduce the risk of transfusion-transmitted malaria (TTM).  Specifically, 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 agent of malaria.  

The recommendations contained in this guidance apply to the collection of Whole Blood and blood components, except Source Plasma.  We do not require blood establishments to screen Source Plasma donors for malaria risk factors because Source Plasma undergoes further manufacturing steps to effectively remove or inactivate pathogens such as Plasmodia spp. (see 21 CFR 630.15(b)(8)).  Licensed plasma derivatives manufactured from Source Plasma have not transmitted malaria.  

This guidance, when finalized, will supersede the guidance of the same title, dated December 2022.

---

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2000-D-0187.

Questions?