Screening of Frequent Donors of Blood and Blood Components

In October, the CBER published the draft guidance for industry "Implementation of Acceptable Abbreviated Donor History Questionnaire and Accompanying Materials for Use in Screening Frequent Donors of Blood and Blood Components". This guidance recognises the abbreviated donor history questionnaire and accompanying materials, version 1.3 dated August 2011. It was prepared by the AABB Donor History Task Force (referred to as “task force”) as an acceptable mechanism for collecting blood donor history information from frequent donors of blood and blood components that is consistent with the FDA requirements and recommendations.

The aDHQ (donor history questionnaires) documents will provide blood establishments collecting blood and blood components (referred to as “manufacturers” or “you”) with a specific process for administering questions to frequent donors of blood and blood components (referred to as “frequent blood donors”) to determine their eligibility to donate.

This guidance also recommends licensed manufacturers who choose to implement the acceptable aDHQ documents to report the manufacturing change consisting of the implementation of the aDHQ documents under 21 CFR 601.12 (§ 601.12).

Please see the complete draft guidance "Implementation of Acceptable Abbreviated Donor History Questionnaire and Accompanying Materials for Use in Screening Frequent Donors of Blood and Blood Components".

Author
Axel H. Schroeder
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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