Zdrowie i gospodarka · 20/11/2013

FDA Releases Draft Guidance for Industry: 510(k) Submissions for Nucleic Acid-Based HLA Test Kits

The Food and Drug Administration (FDA) has made available a draft document outlining recommendations for submitting 510(k) premarket notifications for nucleic acid-based human leukocyte antigen (HLA) test kits used in transfusion and transplantation, with the goal of improving the validation of these kits.