U.S. Food & Drug Administration (FDA) CBER's Biologics Guidances and Rules Update

Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation - Guidance for Industry (PDF - 66KB) 
Posted: 7/31/2015