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# FDA Guidance on Blood and Component Donor Screening
- URL: https://www.fdaweb.com/fda-guidance-on-blood-and-component-donor-screening/
- Published: 2016-05-27T12:00:00.000Z
- Updated: 2026-09-14T21:05:51.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5135784

FDA has posted a [guidance](http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM273685.pdf?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery) on “Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Blood and Blood Components.” The document recognizes standardized full-length and abbreviated donor history questionnaires prepared by the AABB Donor History Task Force 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. The documents are being updated to align with the requirements promulgated in a final rule published in the *Federal Register* 5/22/2015 entitled “Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use”, which became effective 5/23/2016.