REGULATORY UPDATE: AABB, ABC and ARC Submit Comments to FDA on Malaria Draft Guidance

March 17, 2025

AABB, America’s Blood Centers (ABC) and the American Red Cross (ARC) recently submitted joint comments to the Food and Drug Administration’s January 2025 draft guidance, "Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria."

The joint comments, developed by AABB’s Transfusion Transmitted Diseases Committee in collaboration with ABC and ARC, reflect the considerations and priorities of the blood community.

The comments include requests for:

Continuing the current approach to transfusion-transmitted malaria risk reduction without testing.
Reinstating the definitions of “malaria-endemic area” and the “three-month travel deferral.”
Implementing a universal testing option without malaria risk questions.
Clarification on the collection of information regarding malaria symptoms.
Testing for individuals with prior residence in malaria-endemic countries.
Clarification on the definition of a “second period of residence.”
Further explanation of case definitions and geographic criteria during periods of local malaria transmission in the U.S.
A shortened lookback period.
An extended implementation period.

Members with questions may contact regulatory@aabb.org.