REGULATORY UPDATE: FDA Addresses Current Ebola Outbreak Risks
June 30, 2026
The Food and Drug Administration issued a safety and availability notice and updated guidance on Monday to provide blood establishments with recommendations for assessing blood donor eligibility, donor deferral and blood product management related to Ebola disease outbreaks.
These preventative measures reflect ongoing monitoring of the rapidly evolving situation and are consistent with actions taken by CDC and the U.S. Department of Homeland Security “to implement enhanced travel screening, entry restriction and public health measures to prevent Ebola disease from entering the United States amid the ongoing outbreaks in Africa.” (Additional information is available on CDC’s web page.)
Blood Safety
While the Ebola disease outbreaks in Uganda and the Democratic Republic of the Congo (DRC) do not extend to the United States, FDA has proactively responded to the severity of the disease and the potential risk by:
- Reaffirming that 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.
- Recommending that blood establishments update their donor eligibility processes at this time to include asking donors about residency or travel to the DRC and Uganda based on the rapidly evolving risks in those two countries.
- Acknowledging that routine measures currently in place to screen every blood donor effectively prevent individuals with symptomatic Ebola disease from donating blood, in addition to these safeguards required of all AABB-accredited facilities:
- Blood donors must be in good health and must have a normal temperature on the day of donation (CFR 21 CFR 630.10), which would identify and defer individuals with clinical symptoms of Ebola disease.
- On the day of donation, each donor must read the Blood Donor Educational Materials, which instruct individuals that they must not donate blood if they have ever had Ebola disease.
In addition, multiple safety measures intended to address malaria risk by deferring individuals who have traveled to or resided in countries where malaria is endemic will further protect the safety of the blood supply related to Ebola disease risk because individuals who have traveled to or resided in Uganda and the DRC will be
automatically deferred for malaria risk.
AABB-accredited biotherapies facilities may consider this important information when evaluating their policies and processes regarding Ebola risk until more specific information is available from FDA.
Updates to FDA Guidance
The updated guidance does not include major changes to existing recommendations. However, the guidance expands its scope beyond the 2017 document, which focused on Zaire ebolavirus, to apply to all Orthoebolavirus species that cause Ebola disease in humans, including Sudan virus, Tai Forest virus and Bundibugyo virus. The update comes as the Democratic Republic of the Congo and Uganda respond to Ebola disease outbreaks caused by Bundibugyo virus.
As noted in the safety and availability notice, FDA’s updated guidance continues to recommend:
- An indefinite deferral for individuals with a history of Ebola disease.
- An eight-week deferral for individuals who have recently traveled to or resided in affected countries or who have had specified exposures to individuals with Ebola disease, during an Ebola disease outbreak.
The updated guidance also:
- Includes recommendations for donor history questionnaires (DHQs), blood product quarantine and retrieval, notification of consignees and biological product deviation reporting.
- States that blood establishments do not need to independently determine when enhanced Ebola donor screening should begin.
- Clarifies a change in the agency's process where FDA, rather than CDC, will notify establishments when additional screening measures should be implemented and specify the countries subject to travel and residency screening.
AABB’s Donor History Task Force is reviewing the updated guidance and will update the Ebola DHQ questions and toolkit in the coming days.
Additional information related to Ebola disease is available on the AABB website. Members may contact AABB’s Department of Regulatory Affairs with any questions.
