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# Glycemic Control Device Guidance
- URL: https://www.fdaweb.com/glycemic-control-device-guidance/
- Published: 2022-05-05T12:00:00.000Z
- Updated: 2026-09-14T17:43:26.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5151751

FDA has published a guidance, *Feasibility and Early Feasibility Clinical Studies for Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients with Type 2 Diabetes Mellitus*, with agency recommendations for studies on the medical devices. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/feasibility-and-early-feasibility-clinical-studies-certain-medical-devices-intended-therapeutically?ref=fdaweb.com) says manufacturers frequently request FDA feedback about feasibility and early feasibility clinical studies for the devices. “This guidance represents the agency’s initial thinking on feasibility and early feasibility clinical studies for these medical devices,” it says. “FDA’s recommendations may change as more information becomes available.”