Draft Guidance: Feasibility Studies for Certain Type 2 Diabetes Devices

The FDA issued a draft guidance on feasibility clinical studies for therapeutic Type 2 Diabetes medical devices and requests your input.

If your email program has trouble displaying this email, view as a webpage. The FDA Issues Draft Guidance on Feasibility and Early Feasibility Clinical Studies for Certain Medical Devices for Type 2 Diabetes Today, the U.S. Food and Drug Administration (FDA) issued the draft guidance: Feasibility and Early Feasibility Clinical Studies for Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients with Type 2 Diabetes Mellitus. The FDA is seeking input from industry, researchers, clinicians, patients, and other interested stakeholders on the draft guidance. This draft guidance provides recommendations for feasibility and early feasibility clinical studies for certain medical devices intended to therapeutically improve glycemic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. These medical devices are intended to therapeutically reduce glycated hemoglobin (HbA1c) in Type 2 Diabetes Mellitus patients independent of medication (for example, insulin) delivery. Read the Guidance Note: This guidance is not for implementation at this time. Submit comments on this draft guidance This draft guidance will be open for public comments for 60 days at https://www.Regulations.gov under docket number FDA-2021-D-0131. Questions? If you have questions about this draft guidance, contact the Division of Industry and Consumer Education.

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