Zdrowie i gospodarka · 03/01/2023
FDA Classifies Gastrointestinal Lesion Software Detection System into Class II Special Controls
The FDA has classified the gastrointestinal lesion software detection system into Class II special controls, aiming to provide a reasonable assurance of safety and effectiveness, while enhancing patients' access to innovative devices.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →