FDA issues draft guidance to investigators, manufacturers of artificial pancreas systems

SILVER SPRING, Md. — In an effort to help advance the development of devices that automatically monitor blood glucose and provide proper insulin doses in people with Type 1 diabetes, the Food and Drug Administration has issued draft guidance to help investigators and manufacturers as they develop and seek approval for these products.

The FDA said the development for artificial pancreas device systems potentially could reduce the risk of dangerous complications caused by Type 1 diabetes, such as extreme blood-glucose levels, among others. The agency's draft guidance includes such recommendations as a three-phase clinical study progression in order for studies to move to an outpatient setting as quickly as possible, the FDA said.

“The FDA is focused on improving the process for the study and approval of artificial pancreas systems, and developed this guidance to provide maximum flexibility to manufacturers seeking to bring this device to U.S. patients,” said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health. “We understand how this device could change the lives of millions of Americans with diabetes, and we want our safety and effectiveness review to give patients the confidence that the device works.”

Type 1 diabetes is a condition that occurs when the immune system attacks insulin-producing pancreatic beta cells, thus forcing patients to rely on injections, pumps or other devices to maintain their blood-glucose levels.

For the full draft guidance, click here.


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