REGULATORY UPDATE: AABB Updates Ebola Materials to Reflect FDA Guidance

AABB's Donor History Task Force has updated the Association's Ebola disease materials to reflect the Food and Drug Administration's revised Ebola guidance and safety notice. The June 29 FDA notice triggers implementation of additional donor screening measures in response to the evolving risk in the Democratic Republic of the Congo and Uganda.

AABB has updated the Ebola toolkit, Ebola donor screening documents (DHQ, flowcharts,  and educational materials), and the Evaluating Donors for Risk of Ebola Disease web page to reflect FDA recommendations for implementation of donor screening for Ebola risk, including residency in or travel to the DRC and Uganda. 

Following a prompt review, FDA concurs with the updated Ebola DHQ, flowcharts, and donor educational materials as posted by AABB. This review confirms alignment with the guidance but was not a formal review of the DHQ and flowcharts that would be required for a major revision. Additionally, FDA has confirmed that blood establishments should incorporate the revised screening recommendations into their donor eligibility processes by July 27.

Members may contact AABB’s Department of Regulatory Affairs with questions.