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Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients with Type 2 Diabetes Mellitus Draft Guidance for Industry and Food and Drug Administration Staff May 2021
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- FDA-2021-D-0131
- Issued by:
-
Guidance Issuing OfficeCenter 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This draft guidance document provides recommendations for feasibility and early feasibility clinical studies for certain medical devices intended to therapeutically improve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.