REGULATORY UPDATE: AABB Submits DHQ Version 3.0 to FDA for Formal Review

As discussed during an Aug. 18 Hot Topic Discussion, AABB has submitted the AABB Donor History Questionnaire Version 3.0 (DHQ v3.0) and Related Materials to FDA for formal review and acceptance. AABB anticipates that this full version review across multiple documents will require 3 months or longer for FDA to complete.

AABB initially planned to share the draft documents during the 2022 Annual Meeting education session, “Keeping Up with the Donor History Task Force.” The session has been transitioned to the Nov. 6-7 Virtual Annual Meeting, where it will be available as an on-demand session. Following the virtual meeting, AABB will post the draft documents on the AABB website for use with implementation planning only. The documents must not be considered final.

AABB would like to thank the members of the Donor History Task Force for their hard work and ongoing commitment to updating and maintaining the DHQ system of documents.

Those with questions may contact regulatory@aabb.org for additional information.