REGULATORY UPDATE: FDA Draft Guidance Proposes Selective Donor Testing Strategy for Malaria Risk
January 15, 2025
The U.S. Food and Drug Administration
issued a new draft guidance for industry today that proposes to selectively test blood donations to reduce the risk of transfusion-transmitted malaria (TTM) in blood and blood components, excluding source plasma.
In the draft guidance, FDA describes the following testing strategy:
FDA noted that while “testing blood and blood components (except source plasma) for evidence of malaria is necessary to reduce adequately and appropriately the risk of TTM,” the agency determined that testing each donation itself is not necessary. As an alternative, blood establishments may implement one of the following procedures, described on page 9:
- A selective testing strategy for donations from donors with a history of malaria, residence in, or travel to a malaria-endemic country, as well as donations from regions in the U.S. with FDA-identified local malaria transmission.
Use of pathogen-reduction technology for platelets and plasma using FDA-approved devices indicated for P. falciparum, per manufacturer instructions, for donations from donors with malaria history, residence in or travel to malaria-endemic country or from U.S. regions with FDA-identified local transmission.
The proposed recommendations follow the March 2024 approval of the first
FDA-licensed nucleic antibody test to screen blood donations for malaria, which is intended for the direct detection of
Plasmodium (
P. falciparum, P. malariae, P. vivax, P. ovale and
P. knowlesi) DNA and RNA in whole blood donor samples. The agency also considered current TTM risk, the
advice of the Blood Products Advisory Committee and the available evidence.
When finalized, the draft guidance will supersede the agency’s December 2022 guidance of the same name.
AABB will submit comments to the draft guidance during the 60-day comment period. Those with questions may contact
regulatory@aabb.org.
