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This draft guidance document provides recommendations for feasibility and early feasibility clinical studies for certain medical devices intended to therapeutically improve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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All written comments should be identified with this document's docket number: FDA-2021-D-0131.