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GUIDANCE DOCUMENT

Recommendations for Donor Questioning, Deferral, Reentry and Product Management to Reduce the Risk of Transfusion-Transmitted Malaria Guidance for Industry August 2014

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 our, FDA's, recommendations for questioning and deferring donors of blood and blood components, allowing their reentry, and product management to reduce the risk of transfusion-transmitted malaria. The recommendations contained in this guidance apply to the collection of Whole Blood and all blood components with the exception of Source Plasma. Donors of Source Plasma are excluded from deferral due to malaria risk under Title 21 of the Code of Federal Regulations 640.63(c)(9) (21 CFR 640.63(c)(9)).


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