Labeling of Red Blood Cell Units With Historical Antigen Typing Results; Guidance for Industry; Availability

摘要

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Labeling of Red Blood Cell Units with Historical Antigen Typing Results; Guidance for Industry." The guidance document provides establishments that collect blood and blood components for transfusion with recommendations for labeling Red Blood Cell (RBC) units with non-ABO/Rh(D) antigen typing results obtained from previous donations (historical antigen typing results). The guidance provides recommendations to transfusion services for managing RBC units labeled with historical antigen typing results. The guidance also provides licensed blood establishments that choose to implement labeling of RBC units with historical antigen typing results instructions regarding how to report the manufacturing and labeling changes under the biologics regulations. The guidance does not apply to test results for ABO and Rh(D) antigens. The guidance announced in this notice finalizes the draft guidance of the same title dated January 2017.