Draft guidance for artificial pancreas issued by FDA

The FDA issued draft guidance to help make progress in the development and approval of an artificial pancreas system for the treatment of type 1 diabetes. The agency is asking industry, researchers, the clinical community and other stakeholders to provide their input on the types of clinical trials that should be conducted and what their target outcomes should be to demonstrate safety and efficacy.

The current draft guidance addresses the Low Glucose Suspend system, which can potentially help reduce the severity of hypoglycemia by temporarily reducing or halting insulin delivery. The draft guidance provides recommendations for those planning to develop and submit an application for such a system intended for single patient use in the home environment, according to an agency press release.

Currently, the FDA is working on a second draft guidance — expected to be released by the end of the year — to help manufacturers and researchers develop more autonomous artificial pancreas systems.

“Our goal is to provide a clear pathway for artificial pancreas development so that people with diabetes can benefit from innovative medical devices,” Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in the release. “Getting a safe and effective artificial pancreas system to Americans with type 1 diabetes is an FDA priority.”

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