Today, the U.S. Food and Drug Administration (FDA) issued final orders to reclassify two types of hepatitis C virus (HCV) diagnostic tests from class III to II. With these final orders, devices of these types may go through the FDA’s 510(k) pathway for clearance instead of the premarket approval (PMA) pathway. Class II devices are required to comply with special controls to provide a reasonable assurance of safety and effectiveness. These final orders provide the special controls, that in addition to general controls, will provide a reasonable assurance of safety and effectiveness of these HCV tests.