Implementation of acceptable full-length and abbreviated donor history questionnaires and accompanying materials for use in screening donors of blood and blood components: guidance for industry
- Collection:
- Health Policy and Services Research
- Contributor(s):
- Center for Biologics Evaluation and Research (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Biologics Evaluation and Research, May 2023
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Blood Donation Blood Donors Donor Selection Government Regulation Mandatory Testing Surveys and Questionnaires United States
- Genre(s):
- Guideline Technical Report
- Abstract:
- This guidance recognizes, as acceptable, the standardized full-length and abbreviated donor history questionnaires and accompanying materials, version 4.0 dated May 2023, prepared by the AABB Donor History Task Force . This guidance also provides recommendations to licensed establishments on how to report implementation of the acceptable AABB donor history questionnaires and accompanying materials (DHQ documents) under Title 21 of the Code of Federal Regulations 601.12 (21 CFR 601.12). The DHQ documents provide blood establishments that collect blood and blood components with a specific process for administering questions to donors of blood and blood components to determine their eligibility to donate. Acceptable DHQ documents are those documents that FDA has determined provide blood establishments with one means of obtaining donor history information to determine if a donor is eligible, consistent with FDA requirements and recommendations. The DHQ documents have been updated to align with FDA’s current requirements and recommendations for blood donor eligibility. This guidance supersedes the document entitled, “Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Blood and Blood Components,” dated May 2020. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (i, 6 pages))
- NLM Unique ID:
- 9918662585806676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918662585806676