REGULATORY UPDATE: FDA Issues Final Malaria Guidance

The Food and Drug Administration issued a final guidance on Wednesday that makes permanent the recommendations to reduce the risk of transfusion transmission of malaria first issued in April 2020. At that time, FDA shared its expectation that the recommendations set forth in the guidance would continue to apply outside the context of the COVID-19 public health emergency.  
 
Through the final guidance, FDA retained the deferral following travel to malaria-endemic regions reduced to 3 months based on the Agency’s evaluation of the available scientific and epidemiological data on malaria risk. The agency also removed the travel deferral for certain donors of pathogen-reduced platelets and plasma based on FDA-approved pathogen-reduction device data.  

These final recommendations are unchanged from the April 2020 guidance and were issued for immediate implementation. FDA described in the guidance, “Although the April 2020 guidance stated that we intended to reissue the guidance within 60 days following the termination of the public health emergency, we are not delaying this issuance because the guidance represents our current thinking on the topic.”

Individuals with questions may contact regulatory@aabb.org.