Revised recommendations for reducing the risk of human immunodeficiency virus transmission by blood and blood products

Revised recommendations for reducing the risk of human immunodeficiency virus transmission by blood and blood products

Collection:
Health Policy and Services Research
Series Title(s):
Guidance for industry
Contributor(s):
United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Biologics Evaluation and Research (U.S.), issuing body.
Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, August 2020
Language(s):
English
Format:
Text
Subject(s):
Blood Donors
Blood Transfusion
HIV
HIV Infections -- prevention & control
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
Genre(s):
Technical Report
Abstract:
This revised 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. This updates the guidance of the same title dated April 2020. The April 2020 guidance superseded the December 2015 guidance of the same title (Notice of Availability, 80 FR 79913 (December 17, 2015)). The recommendations contained in this guidance apply to the collection of blood and blood components, including Source Plasma.
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, 17 pages)).
NLM Unique ID:
9918227270706676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918227270706676