Feasibility and Early Feasibility Clinical Studies for Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients with Type 2 Diabetes Mellitus: Guidance for Industry and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Medical Devices
Topics
Investigational Device Exemption (IDE), Premarket
Published
May 6, 2022
Last updated
May 5, 2022
Description
This document provides guidance for conducting clinical studies on medical devices to improve glycemic control in patients with type 2 diabetes.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)