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GUIDANCE DOCUMENT

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

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2021-D-0131
Issued by:
Guidance Issuing Office
Center 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.

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5630 Fishers Lane, Rm 1061
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All written comments should be identified with this document's docket number: FDA-2021-D-0131.

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