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FDA Releases Draft Guidance On Closed-Loop Artificial Pancreas Devices

Draft issued Dec. 1 emphasizes flexible clinical trial designs to support approval of glucose monitor/insulin pump combination devices that work together without the need for patient intervention.

FDA released long-awaited draft guidance Dec. 1 to help pave the way for the development of a fully closed-loop “artificial pancreas” device, which is poised to change the way patients manage type 1 diabetes by automating the process.

The draft outlines what information sponsors should include in investigational device exemption applications needed to begin U.S. clinical trials and...

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