Federal Register Notice: FDA is making available a draft document entitled Guidance for Industry: 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. It provides recommendations to submitters and FDA reviewers in preparing and reviewing 510(k) submissions for the nucleic acid-based kits used for matching of donors and recipients in transfusion and transplantation. It also provides detailed information on the types of studies FDA recommends for validation of the kits submitted as 510(k)s. To download the draft guidance, click here. To view this notice, click here.