FDA Guidance for Industry Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria
Title:
FDA Guidance for Industry Recommendations to Reduce the Risk
of Transfusion-Transmitted Malaria
Origin/Publisher:
Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/ , http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM080784.pdf
Document Type:
Guidance for Industy
Content:
This 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 (21 CFR 630.15(b)(8)). This guidance supersedes
the guidance titled “Revised Recommendations to Replace the Risk of Transfusion-Transmitted
Malaria; Guidance for Industry” dated April 2020 (April 2020 guidance).