Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability

摘要

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled "Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry." The draft guidance document provides blood establishments that collect blood and blood components for transfusion or further manufacture, including Source Plasma, with FDA recommendations for assessing blood donor suitability, donor deferral, and blood product management in the event that an outbreak of Ebola virus disease (EVD) with widespread transmission is declared in at least one country. The draft guidance document applies primarily to Ebola virus (species Zaire ebolavirus), but recommendations are expected to apply to other viruses of the Ebolavirus genus such as Sudan virus, Bundibugyo virus, and Ta[iuml] Forest virus. The recommendations would apply to routine collection of blood and blood components for transfusion or further manufacture, including Source Plasma.