FDA In Brief: FDA Issues Draft Guidance on Early Clinical Studies for Certain Medical Devices to Improve Glycemic Control for Type 2 Diabetes

FDA in Brief

• For Immediate Release: May 19, 2021

The following quote is attributed to Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health

“As part of our commitment to help accelerate the development of innovative medical devices to improve patient care, the draft guidance issued today provides the FDA’s initial thinking on feasibility and early feasibility clinical studies for certain medical devices intended to improve glycemic control.

The prevalence of Type 2 diabetes in the U.S. has led to a growing interest among medical device manufacturers and researchers—as well as the diabetes community—to develop therapeutic devices that could improve glycemic control. While there are FDA-cleared and approved devices that help patients measure and monitor blood glucose, and devices that dose and deliver insulin, there are currently no legally marketed medical devices in the U.S. that are intended to therapeutically improve glycemic control in patients with Type 2 diabetes.

With our focus on improving public health and making technologies available that can help improve the quality of life for those with chronic diseases like Type 2 diabetes, we’re interested in getting feedback from manufacturers as well as the diabetes community on this draft guidance.”

Additional Information

• Today the U.S. Food and Drug Administration issued a draft guidance providing recommendations for feasibility and early feasibility clinical studies for certain medical devices intended to therapeutically improve glycemic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, independent of medication delivery.
• Such medical devices include, but are not limited to, neurostimulators and those that mimic or result in anatomical changes similar to those made by bariatric surgical procedures, alter the anatomy and/or physiology of the small intestines or manipulate the sympathetic nervous system.
• Comments may be submitted to the public docket here. Please submit comments for consideration in the development of the report by July 20, 2021.