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GUIDANCE DOCUMENT

Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus Guidance for Industry January 2017

Final
Docket Number:
FDA-2014-D-2175
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

We, FDA, are notifying you, blood establishments that collect blood and blood components for transfusion or further manufacture, including Source Plasma, that we have determined Ebola virus to be a transfusion-transmitted infection (TTI) under Title 21 of the Code of Federal Regulations (CFR) 630.3(l). We are also providing you with recommendations for assessing blood donor eligibility, donor deferral and blood product management in the event that an outbreak of Ebola virus disease (EVD) with widespread transmission occurs in at least one country. This guidance document applies to Ebola virus (species Zaire ebolavirus).1 The recommendations in section III. of this guidance document apply to the routine collection of blood and blood components for transfusion or further manufacture, including Source Plasma. The collection of convalescent plasma from EVD survivors is addressed in section V. of this guidance document. This guidance finalizes the draft guidance entitled, “Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus,” dated December 2015.


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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-2014-D-2175.

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
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ocod@fda.hhs.gov
(800) 835-4709
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