Zdrowie i gospodarka · 21/01/2022

FDA Proposes Classification of Human Leukocyte, Neutrophil and Platelet Antigen and Antibody Tests as Class II Devices

The US Food and Drug Administration (FDA) is proposing to classify Human Leukocyte Antigen (HLA), Human Platelet Antigen (HPA), and Human Neutrophil Antigen (HNA) devices, a type of medical device, under special controls to ensure safety and effectiveness, and will consider public comments before publishing a final regulation.