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GUIDANCE DOCUMENT

Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria Guidance for Industry April 2020

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2000-D-0187
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

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)).

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Submit Comments Online

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
[email protected]
(800) 835-4709
(240) 402-8010
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