Business · 30/10/2017
FDA Classifies Aquaporin-4 Autoantibody Immunological Test System as Class II Device with Special Controls
The FDA has classified the Aquaporin-4 autoantibody immunological test system as a Class II device with special controls, aiming to ensure the device's safety and effectiveness while reducing regulatory burdens and enhancing patient access to innovative devices.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →