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

GUIDANCE DOCUMENT

• Docket Number: FDA-2014-D-2175
• Issued by: Center for Biologics Evaluation and Research

We, FDA, are notifying you, blood establishments that collect blood and blood components for transfusion or further manufacture, including Source Plasma, that we have determined Ebola disease to be a transfusion-transmitted infection (TTI) under Title 21 of the Code of Federal Regulations (CFR) 630.3(l).  We are also providing you with recommendations for assessing blood donor eligibility, donor deferral and blood product management in the event of an Ebola disease outbreak in at least one country.  This guidance document was developed in response to the 2014 Ebola virus (species Orthoebolavirus zairense) outbreak in West Africa.  However, FDA expects the recommendations to apply to all Orthoebolaviruses that cause Ebola disease in humans (e.g., Bundibugyo virus, Tai Forest virus, Sudan virus) should an Ebola disease outbreak occur.

This guidance updates the final guidance titled, “Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus,” dated January 2017.  The January 2017 guidance finalized the draft guidance of the same title dated December 2015. 

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