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FDA tells HCT/P establishments how to weigh Ebola risk in donor eligibility

🇺🇸 FDA CBER · Mon 26 Oct 2026

CBER says Ebola transmission through cells and tissue products has never been described, but suggests establishments consider 21-day exposure and travel history for donors during the Bundibugyo outbreak.

The US Food and Drug Administration's Center for Biologics Evaluation and Research has published a safety communication for establishments handling human cells, tissues, and cellular and tissue-based products (HCT/Ps). It addresses Ebola disease and donor eligibility determinations. The text is dated 16 July 2026.

The communication follows a CDC Health Alert Network advisory issued in May 2026 on an Ebola outbreak in the Democratic Republic of the Congo and Uganda caused by Bundibugyo virus. The DRC Ministry of Health confirmed the outbreak in Ituri Province on 15 May, the country's 17th recorded Ebola outbreak. FDA says no cases had been confirmed in the United States as of 14 July and that the risk of spread to the US is considered low. It points readers to CDC for current case counts, which it says are changing rapidly.

On HCT/Ps specifically, FDA notes that transmission of Ebola disease through implantation, transplantation, infusion or transfer of these products has not been described, so the risk remains theoretical. It also states that no donor screening test for Ebola disease is available. Existing safeguards, such as the donor medical history interview and review of relevant medical records under 21 CFR 1271.3(n) and (s), may already identify donors who have been diagnosed with Ebola or are at greatest risk of infection.

Beyond those routine measures, FDA says establishments may also wish to consider whether, in the 21 days before HCT/P recovery, the donor was diagnosed with or suspected of having Ebola disease. Other questions are whether the donor had close contact with a confirmed or suspected case, resided in or travelled to a country with widespread transmission, or was notified by a public health authority of possible exposure. The 21-day window matches the upper end of the incubation period of 2 to 21 days that FDA cites for Bundibugyo virus disease. FDA says it will keep monitoring cases and any information on transmission risk through HCT/Ps, and will communicate further as appropriate.

What it means for your team

  • Quality and donor-eligibility teams should check whether current screening procedures capture the four 21-day lookback considerations FDA lists: diagnosis or suspicion, close contact, residence or travel, and public health notification.
  • With no Ebola donor screening test available, eligibility decisions rest on history interviews and record review, so interviewer training and documentation matter.
  • The items are framed as considerations for establishments, not new requirements; any procedural change should be justified within the establishment's own risk assessment.
  • Teams should monitor the CDC situation page and its map of impacted areas, since the list of countries with widespread transmission may change.

Official source: FDA CBER ↗

Article written by VigiEye from the official source (FDA CBER). AI-assisted; check the source before acting.

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