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; Availability

概要

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance entitled "Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components." The guidance document provides blood establishments that collect blood and blood components with 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 the guidance apply to the collection of Whole Blood and blood components intended for transfusion or for use in further manufacturing, including Source Plasma. The guidance removes the recommendations to defer indefinitely blood donors for geographic risk of possible exposure to bovine spongiform encephalopathy for time spent in the United Kingdom (U.K.) from 1980 to 1996 and for time spent in France and Ireland from 1980 to 2001, and receipt of a blood transfusion in the U.K., France, and Ireland from 1980 to the present. The guidance also provides recommendations for requalification of individuals previously deferred