Zdrowie i gospodarka · 06/05/2022

FDA Releases Guidance on Feasibility and Early Feasibility Clinical Studies for Type 2 Diabetes Medical Devices

The Food and Drug Administration (FDA) has released a final guidance document titled 'Feasibility and Early Feasibility Clinical Studies for Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients with Type 2 Diabetes Mellitus.' This document provides recommendations for conducting clinical studies on medical devices designed to lower blood sugar levels in Type 2 diabetes patients without relying on insulin medication.