FDA Guidance for Blood Donor History Questionnaires and Accompanying Materials

Recommendation

7/8 May 2024

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Regulatory Requirements and Practical Implementation

In May, the FDA published a guideline on" Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Blood and Blood Components" for immediate implementation. Already years ago, the AABB Donor History Task Force prepared questionnaires for the screening of frequent donors of blood and blood components. The CBER recognised these documents for their guidances and implemented them as consistent with the FDA requirements and recommendations.

In February 2016 the AABB Task force finalised their 2.0 Version of  the "abbreviated donor history questionnaires (FL-DHQ and a DHQ, respectively) and accompanying materials". The new version considers the requirements announced in the final rule published in the Federal Register of May 22, 2015 entitled “Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use” (80 FR 29842), which became effective on 23 May 2016. Additionally it includes the "FDA Recommendations: Reducing the Risk of HIV Transmission by Blood and Blood Products" adopted in December 2015.

This guidance supersedes the following documents entitled:

• “Guidance for Industry: Implementation of Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Donors of Blood and Blood Components” dated October 2006, which accepted version 1.3 of the AABB full-length DHQ (Ref. 2); and
• “Guidance for Industry: Implementation of an Acceptable Abbreviated Donor History Questionnaire and Accompanying Materials for Use in Screening Frequent Donors of Blood and Blood Components” dated May 2013 (Ref. 3), which accepted version 1.3 of the AABB abbreviated DHQ.

Additionally, this guidance supersedes FDA’s acceptance of the referenced donor history questionnaires and accompanying materials in the documents entitled:

• “Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products” dated May 2010 (Ref. 4), which accepted revisions to version 1.3 of the AABB full-length DHQ2; and
• “Guidance for Industry: Recommendations for Donor Questioning, Deferral, Reentry and Product Management to Reduce the Risk of Transfusion-Transmitted Malaria” dated August 2014 (Ref. 5), which accepted revisions

To get more information about the recommendations for blood establishments collecting blood and blood components please see the complete Guidance for Industry  Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Blood and Blood Components.