Fast-breaking News from AABB PulsePoints The following has been reproduced from the October 27, 2006 AABB PulsePoints, an electronic news alert provided by the American Association of Blood Banks.

October 27, 2006
No. 755

FDA Guidance Recognizes AABB DHQ Documents

AABB PulsePoints

The Food and Drug Administration (FDA) today released “Guidance for Industry: Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Human Donors of Blood and Blood Components." The guidance recognizes version 1.1 of the Donor History Questionnaire (v.DHQ-1.1), completed in June 2005 by the AABB Donor History Task Force, as an acceptable mechanism that is consistent with FDA requirements and recommendations for collecting donor history information. The guidance also advises licensed facilities how to report the manufacturing changes to FDA.

The DHQ documents prepared by the AABB Donor History Task Force provide licensed and unlicensed manufacturers with a specific process for administering questions to donors of blood and blood components to determine their eligibility to donate. These acceptable DHQ documents offer one means of complying with donor screening requirements in 21 CFR 640.3 and 640.63.

To view the guidance document in its entirety, visit http://www.fda.gov/cber/dhq/dhq.htm.