Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Blood and Blood Components: Guidance for Industry

Issue Date: May 11, 2023
Issued by: Center for Biologics Evaluation and Research
Topic(s): Blood, Blood Products
Status: Final

Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Blood and Blood Components: Guidance for Industry

This guidance recognizes, as acceptable, the standardized full-length and abbreviated donor history questionnaires and accompanying materials, version 4.0 dated May 2023, prepared by the AABB Donor History Task Force . This guidance also provides recommendations to licensed establishments on how to report implementation of the acceptable AABB donor history questionnaires and accompanying materials (DHQ documents) under Title 21 of the Code of Federal Regulations 601.12 (21 CFR 601.12).

Download the Guidance Document