Zdrowie i gospodarka · 03/08/2015

FDA Announces Final Guidance for 510(k) Submissions for Nucleic Acid-Based HLA Test Kits

The FDA has released a final guidance document outlining recommendations for submitting premarket notification (510(k)) submissions for nucleic acid-based human leukocyte antigen (HLA) test kits used in transfusion and transplantation, providing clarity for industry on preparing and reviewing these submissions.