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GUIDANCE DOCUMENT

Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma Guidance for Industry May 2020

Download the Final Guidance Document
Final Level 2 Guidance
Docket Number:
FDA-2011-D-0722
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

This guidance recognizes the standardized full-length and abbreviated donor history questionnaires and accompanying materials, version 2.1 dated May 2020, 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).

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2011-D-0722.

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