Product Code: 198001DB
This checklist is intended to supplement your understanding of the FDA’s new recommendations permitting the labeling of RBC units based on historical antigen typing results. Specifically, the checklist serves as a “quick reference” to the recommendations in Section III.A, B, and C found on pages 3-6 of the final guidance.* The checklist contains hyperlinks to other relevant regulations and will assist you in evaluating new policy options, reviewing compliance and operational considerations, and developing standard operating procedures. A link to the final guidance itself appears below.
*Food and Drug Administration. Guidance for industry: Labeling of red blood cell units with historical antigen typing results. Silver Spring, MD: CBER Office of Communication, Outreach, and Development, 2018. [Available at https://www.fda.gov (accessed January 15, 2019).]
