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# Diabetes Device Feasibility Studies Guidance
- URL: https://www.fdaweb.com/diabetes-device-feasibility-studies-guidance/
- Published: 2022-05-06T12:00:00.000Z
- Updated: 2026-09-14T17:43:40.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5151761

*Federal Register* notice: FDA has made available a final guidance entitled “Feasibility and Early Feasibility Clinical Studies for Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients with Type 2 Diabetes Mellitus.” The document’s scope applies to devices such as neurostimulators, and those that mimic or result in anatomical changes similar to those made by bariatric surgical procedures, alter the anatomy and/or physiology of the small intestines, or manipulate the sympathetic nervous system. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-05-06/pdf/2022-09738.pdf?ref=fdaweb.com).