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  1. Safety & Availability (Biologics)

Important Information for Blood Establishments Regarding Ebola Disease and Blood Donation

Date: June 29, 2026

Background

The Centers for Disease Control and Prevention (CDC) is monitoring an outbreak of Bundibugyo virus disease in the Democratic Republic of the Congo (DRC) and Uganda.  Bundibugyo virus is one of four Orthoebolaviruses that causes Ebola disease in humans. This is a rapidly evolving situation and the CDC and Department of Homeland Security have implemented enhanced travel screening, entry restriction and public health measures to prevent Ebola disease from entering the United States amid the ongoing outbreaks in Africa.  For current information on the outbreak, visit CDC’s webpage at Ebola Disease: Current Situation | Ebola | CDC

Blood Safety

Because of the severity of the disease and the potential risk of transmission by blood and blood components, Ebola disease meets the definition of transfusion-transmitted infection 21 CFR 630.3(l); however, transmission of Ebola disease by blood transfusion has not been reported.

Routine measures used to screen every blood donor effectively prevent individuals with symptomatic Ebola disease from donating blood. For example, blood donors must be in good health and must have a normal temperature on the day of donation (21 CFR 630.10). These safeguards would identify individuals who present to donate with clinical symptoms of Ebola disease.  In addition, blood establishments provide educational materials before donation that instruct individuals to not donate blood if they have ever had Ebola disease.  Donors are also typically instructed to report illnesses or symptoms that develop shortly after blood donation so that the blood establishment can assess if their donation is suitable for transfusion.

In response to the 2014 Ebola virus outbreak in West Africa, FDA issued guidance to provide blood establishments with recommendations for assessing blood donor eligibility, donor deferral and blood product management.  We issued an updated guidance in June 2026.  The recommendations are intended to reduce the risk of collecting blood and blood components from individuals that have a history of Ebola disease or may be at risk for exposure because of travel to a country with Ebola disease transmission.  

Considering the current Ebola disease outbreak in DRC and Uganda, we refer blood establishments to the recommendations in our guidance document to update their donor eligibility processes accordingly, including asking donors about residency or travel to DRC and Uganda.  

FDA will continue to monitor the Ebola disease outbreak in coordination with CDC and will issue updated information as it becomes available, including the list of countries for which donor residency and travel history should be assessed.

Resources:

Ebola Disease: Current Situation | Ebola | CDC

Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus: FDA Guidance for Industry

AABB Fact Sheet: Ebola Virus

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