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

Issue Date: May 6, 2022
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, Gastroenterology-Urology , Investigational Device Exemption (IDE)
Status: Final

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

This guidance document provides the FDA’s recommendations for feasibility and early feasibility clinical studies for certain medical devices intended to therapeutically improve glycemic control in patients with Type 2 Diabetes Mellitus (T2DM). These medical devices are intended to therapeutically reduce glycated hemoglobin (HbA1c) in T2DM patients independent of medication (e.g., insulin) delivery. The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of feasibility and early feasibility clinical study submissions for these devices.

Download the Guidance Document