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GUIDANCE DOCUMENT

Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components Guidance for Industry April 2020

Final
Docket Number:
FDA-2012-D-0307
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

We, FDA, are issuing this guidance document to provide you, blood establishments that collect blood and blood components, with revised recommendations intended to reduce the possible risk of transmission of Creutzfeldt-Jakob disease (CJD) and variant Creutzfeldt-Jakob disease (vCJD) by blood and blood components.  The recommendations in this guidance apply to the collection of Whole Blood and blood components intended for transfusion or for use in further manufacturing, including Source Plasma.  We are revising or removing our prior recommendations to screen blood donors for: 1) geographic risk of possible exposure to bovine spongiform encephalopathy, including time spent on United States (U.S.) military bases in Europe; 2) receipt of a blood transfusion in certain vCJD risk countries; 3) risk factors for iatrogenic CJD (i.e., a history of taking human cadaveric pituitary-derived growth hormone (hGH)); 4) having blood relatives with CJD; and 5) a history of injecting bovine insulin.  These changes are summarized in the Appendix of this guidance.


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-2012-D-0307.

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