The volunteer member experts of the
Donor History Task Force, in collaboration with AABB’s Regulatory Affairs staff, have developed the current Blood Donor History Questionnaire(s) (DHQs) and Related Materials to provide a system:
- That is submitted by AABB Regulatory Affairs for FDA review as an acceptable mechanism for collecting blood donor history information from donors of blood and blood components that is consistent with the FDA requirements and recommendations. [21 CFR 630.10] and
- That is posted on the AABB website and where it remains publicly available, along with the
DHQ v2.1 Implementation Toolkit.
- That may be reported by licensed manufacturers as a minor change in a facility’s annual report to FDA under
§601.12(d)if implemented as accepted by FDA (refer to the Implementation section of the guidance)
On 05/05/2020, the
FDA formally recognized the v2.1 DHQ and Related Materials as acceptable for use.
Blood collection establishments are responsible for:
- Reviewing the
guidance to ensure compliance with FDA’s recommendations, and reporting and implementation requirements.
- Reviewing the
DHQ User Brochure for detailed instructions on the limitations and appropriate use of AABB’s FDA-recognized DHQ(s) (for example, adding questions, reformatting materials).
- Reporting the implementation of AABB’s DHQ and related documents as a minor change in the Annual Report [§601.12(d)] to FDA when
implemented as accepted by FDA and without modifications of the version v2.1 documents posted by AABB.
- Compliance with additional FDA requirements under
§601.12, as noted in the
guidance, for licensed blood establishments
implementing a modified version of the FDA accepted v2.1 DHQ materials, such as submission of a PAS [§601.12(b)] for FDA approval prior to implementation of major changes.
Please don’t hesitate to send your questions regarding the v2.1 documents to Regulatory Affairs at