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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Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients with Type 2 Diabetes Mellitus Draft Guidance for Industry and Food and Drug Administration Staff May 2021

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
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


Docket Number:
FDA-2021-D-0131
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This draft guidance document provides recommendations for feasibility and early feasibility clinical studies for certain medical devices intended to therapeutically improve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.

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