Jay Tanna, MS, RAC(US)
Senior Manager, QA
Children's National Hospital
United States

FDA Highlights Ebola Considerations for HCT/P Establishments Amid New Outbreak

In July 2026, the U.S. Food and Drug Administration (FDA) issued a Safety and Availability communication to Human Cells, Tissues, and Cellular and Tissue-Based Product (HCT/P) establishments in response to the ongoing Ebola outbreak in the Democratic Republic of the Congo and Uganda caused by Bundibugyo virus. The communication provides considerations for donor eligibility determinations but does not establish new mandatory donor screening requirements for HCT/P establishments.

FDA noted that establishments may voluntarily consider additional donor screening questions related to Ebola exposure within 21 days prior to donation or recovery. These considerations include whether a donor has been diagnosed with or suspected of having Ebola disease, had close contact with an infected individual, traveled to or resided in an area with widespread transmission, or was notified by public health authorities of a potential exposure.

To assist organizations that choose to implement these voluntary measures, the Donor History Questionnaire (DHQ) Interrogational Task Force has developed example questions and flowcharts to evaluate HCT/P donors for Ebola risk. These tools provide a practical framework for donor screening and eligibility assessment and may help establishments incorporate Ebola-related risk evaluation into existing donor qualification processes. Their use remains voluntary and is not required by FDA.

Importantly, FDA emphasized that existing donor eligibility practices already include evaluation of risk factors, clinical evidence of infection, and donor medical history, which may identify individuals at increased risk for Ebola infection. As a result, the agency stopped short of recommending mandatory changes to donor eligibility procedures for HCT/P establishments at this time.

For cell therapy programs, tissue banks, and transplant centers, the communication serves as a reminder to review donor screening procedures and maintain awareness of emerging infectious disease risks. While no additional testing requirements were announced, organizations may wish to evaluate whether temporary travel and exposure screening measures should be incorporated into their donor eligibility assessment processes based on local risk assessments and operational needs.
The FDA stated that it will continue to monitor the outbreak and provide updated information as needed.

Key Takeaway: At present, the FDA's Ebola communication for HCT/P establishments is advisory rather than prescriptive. Cell therapy programs should remain vigilant, monitor evolving public health information, and assess whether voluntary donor screening enhancements are appropriate for their programs.

references

1. FDA. Important Information for Human Cell, Tissue, and Cellular and Tissue-Based Product (HCT/P) Establishments Regarding Ebola Disease and HCT/P Donation. July 16, 2026.

2. FDA. Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus. Final Guidance for Industry. June 29, 2026.

3. AABB. FDA Issues Ebola Disease Considerations for HCT/P Establishments. July 15, 2026. https://www.aabb.org/docs/default-source/default-document-library/regulatory/ebola-disease-information-for-hct-p-establishments.pdf?sfvrsn=c81e0ca4_4