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GUIDANCE DOCUMENT

Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis Guidance for Industry May 2019

Download the Final Guidance Document Read the Federal Register Notice
Final Level 1 Guidance
Docket Number:
FDA-2018-D-2478
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

We, the Food and Drug Administration (FDA), are notifying you, blood establishments that collect blood and blood components, that we have determined babesiosis to be a relevant transfusion-transmitted infection (RTTI) under 21 CFR 630.3(h)(2).1 Accordingly, we are providing recommendations for donor screening, donation testing, donor deferral and product management to reduce the risk of transfusion-transmitted babesiosis (TTB). The recommendations contained in this guidance apply to the collection of blood and blood components, except Source Plasma.2

This guidance finalizes the draft guidance of the same title dated July 2018.

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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-2018-D-2478.

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