Zdrowie i gospodarka · 02/04/2020

FDA Proposes Reclassification of Hepatitis C Virus RNA Testing Devices

The Food and Drug Administration (FDA) is proposing to reclassify nucleic acid-based hepatitis C virus (HCV) ribonucleic acid (RNA) devices from Class III to Class II, reducing regulatory burdens and allowing for premarket notification instead of premarket approval.