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GUIDANCE DOCUMENT

Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria Guidance for Industry December 2022

Final
Docket Number:
FDA-2000-D-0187
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

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).  

To address the urgent and immediate need for blood and blood components during the Coronavirus Disease 2019 (COVID-19) public health emergency, in April 2020 FDA (we) issued revised recommendations to reduce the risk of TTM during the public health emergency.  The recommendations in the April 2020 guidance were based on the Agency’s evaluation of the available scientific and epidemiological data on malaria risk, and data on FDA-approved pathogen reduction devices.  As stated in the April 2020 guidance, FDA expected implementation of the revised recommendations would not be associated with any adverse effect on the safety of the blood supply and that early implementation of the recommendations may help to address significant blood shortages that occurred as a result of the COVID-19 public health emergency.  Further, the guidance explained that we expected that the recommendations set forth in the revised guidance would continue to apply outside the context of the COVID-19 public health emergency, and that FDA would replace the April 2020 guidance with an updated guidance that incorporates any appropriate changes based on public comments and our experience with implementation.

 


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2000-D-0187.

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010
 
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