Guidance for Industry
Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products
This FDA guidance document provides you, blood establishments that collect blood or blood components, including Source Plasma, with FDA’s revised donor deferral recommendations for individuals with increased risk for transmitting human immunodeficiency virus (HIV) infection.
We (FDA) are also recommending that you make corresponding revisions to your donor educational materials, donor history questionnaires and accompanying materials, along with revisions to your donor requalification and product management procedures.
This guidance also incorporates certain other recommendations related to donor educational materials and testing contained in the memorandum to blood establishments entitled, “Revised Recommendations for the Prevention of Human Immunodeficiency Virus (HIV) Transmission by Blood and Blood Products,” dated April 23, 1992 (1992 blood memo).
This guidance finalizes the draft guidance of the same title dated May 2015 (80 FR 27973, May 15, 2015) and supersedes the 1992 blood memo. The recommendations contained in this guidance apply to the collection of blood and blood components, including Source Plasma.
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Last Updated: 2015-12-21