FDA Issues Draft Guidance on Early Clinical Studies for Certain Medical Devices to Improve Glycemic Control for Type 2 Diabetes

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part of our commitment to help accelerate the development of innovative medical devices to improve patient care, the draft guidance issued today provides the FDA’s initial thinking on feasibility and early feasibility clinical studies for certain medical devices intended to improve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

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“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like Type 2 diabetes, we’re interested in getting feedback from manufacturers as well as the diabetes community on this draft guidance.”

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