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 May 2022
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Guidance Issuing OfficeCenter for Devices and Radiological Health
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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2021-D-0131.