Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma Guidance for Industry June 2023

GUIDANCE DOCUMENT

• Docket Number: FDA-2016-D-1342
• Issued by: Center for Biologics Evaluation and Research

This guidance recognizes, as acceptable, the standardized full-length and abbreviated donor history questionnaires and accompanying materials, version 3.0 dated June 2023, prepared by the Plasma Protein Therapeutics Association (PPTA).   This guidance also advises Source Plasma manufacturers on how to report implementation of the acceptable PPTA Source Plasma donor history questionnaires and accompanying materials (SPDHQ documents) under Title 21 of the Code of Federal Regulations 601.12 (21 CFR 601.12).

The SPDHQ documents provide establishments that collect Source Plasma with a specific process for administering questions to donors to determine their eligibility to donate.  Acceptable SPDHQ documents are those documents that FDA has determined provide Source Plasma collection establishments with one means of obtaining donor history information to determine if a donor is eligible, consistent with FDA requirements and recommendations.  The SPDHQ documents have been updated to align with FDA’s current requirements and recommendations for donor eligibility. 

This guidance supersedes the document entitled “Implementation of an Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma” dated May 2020.

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