Zdrowie i gospodarka · 22/11/2021

FDA Reclassifies Hepatitis C Virus Antibody Assay Devices as 'Hepatitis C Virus Antibody Tests'

The Food and Drug Administration (FDA) is reclassifying certain hepatitis C virus antibody assay devices from Class III to Class II devices, requiring premarket notification, and renaming them as 'Hepatitis C Virus Antibody Tests'. The FDA has identified necessary special controls to ensure the devices' safety and effectiveness.