Revised recommendations to reduce the risk of transfusion-transmitted malaria

Revised recommendations to reduce the risk of transfusion-transmitted malaria

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, April 2020
Language(s):
English
Format:
Text
Subject(s):
Blood Donors
Blood Transfusion
Malaria -- prevention & control
Malaria -- transmission
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 and blood components, with FDA's recommendations to reduce the risk of transfusion-transmitted malaria (TTM). The recommendations contained in this guidance apply to the collection of Whole Blood and blood components, except Source Plasma. Blood establishments are not required to assess Source Plasma donors for malaria risk (see 21 CFR 630.15(b)(8)). This guidance supersedes the guidance dated August 2013 and updated August 2014, entitled, "Recommendations for Donor Questioning, Deferral, Reentry and Product Management to Reduce the Risk of Transfusion-Transmitted Malaria" (Notice of Availability, 78 FR 50421 (August 19, 2013)).
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, 14 pages)).
NLM Unique ID:
9918227271006676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918227271006676