Evaluating Donors for Risk of Ebola Disease

For FDA information specific to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), please refer to Ebola Disease Information for HCT/P Establishments.

June 29, 2026:
The Food and Drug Administration issued a safety and availability notice and updated guidance to provide blood establishments with recommendations for assessing blood donor eligibility, donor deferral and blood product management related to Ebola disease outbreaks. The notice, Important Information for Blood Establishments Regarding Ebola Disease and Blood Donation, triggers the use of the additional donor screening measures and provides the list of countries for which donor travel and residency should be assessed:

"Considering the current Ebola disease outbreak in the Democratic Republic of the Congo (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 the DRC and Uganda."

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.

Information on this page is based on the June 2026 FDA Guidance:
"Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to an Ebola Disease Outbreak” (the Ebola Guidance).

Refer to AABB's Ebola Toolkit updated in July 2026 for instructions on implementation of FDA recommendations.

To revise your DHQ and Donor Education Material refer to these examples: AABB Ebola DHQ and flowcharts, Ebola Donor Education Material.

1) What is required when there is not an Ebola disease outbreak and FDA has not recommended additional donor screening or specified countries for which Ebola disease should be assessed?

FDA's 2026 recommendations state:
"When there are no countries with an Ebola disease outbreak, self-deferral of donors with a history of Ebola disease should provide sufficient protection. We recommend that you update your donor educational materials to instruct donors with a history of Ebola disease to not donate blood or blood components."
You should:

• Continue to use the updated educational material to support self-deferral by those who have a history of Ebola disease.
• Refer to this example to ensure SOPs provide for implementation of the donor history questionnaires (full length, and abbreviated, if used) modified for Ebola disease risk, if needed: AABB Ebola DHQ and Flowcharts and Ebola Donor Education Material.
• Become familiar with:
  • the Ebola Toolkit (includes the checklist and flowcharts) updated in July 2026.
  • the information on the CDC website: Ebola Disease Basics | Ebola | CDC and Ebola Outbreak: Current Situation

2) How will I know to implement the additional regulations?

• FDA, in consultation with CDC, will communicate when the recommendations in section III.A.2 and III.B. of the guidance (additional screening measures) should be implemented and specify the countries for which donor residency and travel history should be assessed.
• AABB will announce in a News Flash and/or other form of broad communication that the additional donor screening measures should be implemented.

3) What should I do when FDA communicates that the recommendations in section III.A.2 and III.B of the guidance (additional screening measures) should be implemented and specifies the countries for which donor residency and travel history should be assessed?

Within 4 weeks of the date of the FDA communication you should implement:

• Updated donor education materials to assist donors with the 5 additional questions.
  Refer to Ebola Donor Education Material.
• Updated DHQs to assess and defer donors based on Ebola risk.
  Refer to AABB Ebola DHQ and Flowcharts.

4) How do we handle post donation information (PDI) and other inventory management concerns?

• Section III.C., page 6 of the guidance, addresses "Product Retrieval, Quarantine, and Notification."
• The Ebola guidance includes a unique approach to PDI.
• Refer to recommendation III.C.2, page 6, which states: "We recommend you contact FDA as soon as possible upon learning that you collected blood or blood components from a donor later determined to have Ebola disease."

Please contact regulatory@aabb.org with questions or for additional information.