FDA proposes draft guidance for the blood industry

Jan. 16, 2025
This revised guidance is for organizations that collect blood.

The U.S. Food and Drug Administration (FDA) is proposing a draft guidance to minimize the threat of the risk of transfusion-transmitted malaria (TTM).

“Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria,” if finalized, will replace the 2022 guidance.

The revision suggests “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,” according to FDA’s announcement. Some of the testing criteria include if the patient has lived in a country with widespread malaria or if the patient has a history of the disease.  

The new recommendations do not apply to Source Plasma.

AABB announced that they will be submitting comments to the FDA during the 60-day comment period.

FDA annoucement 

ID 59511298 © Arne9001 | Dreamstime.com
dreamstime_xxl_59511298
ID 5537159 © Monkey Business Images | Dreamstime.com
dreamstime_xxl_5537159
By bulgn on Adobe Stock
adobestock_417142100
By catalin on Adobe Stock
adobestock_594900830
ID 359048564 © Panuwat Dangsungnoen | Dreamstime.com
dreamstime_xxl_359048564