Zdrowie i gospodarka · 02/04/2020

FDA Proposes to Reclassify Hepatitis C Virus Antibody Assay Devices as Class II Devices

The Food and Drug Administration (FDA) is proposing to reclassify certain hepatitis C virus (HCV) antibody assay devices from Class III to Class II devices, reducing regulatory burdens and allowing for premarket notification instead of premarket approval applications.