FDA issues guidance for study, approval of artificial pancreas

The FDA today issued draft guidance that will help investigators and manufacturers develop and seek approval for artificial pancreas device systems to treat type 1 diabetes.

“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 US patients,” Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, said in a press release. “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.”

The guidance recommends a three-phase clinical study progression that includes an early feasibility study, a transitional study and a pivotal study. The document also suggests ways for sponsors to leverage existing safety and effectiveness data for components that may make up an artificial pancreas system, as well as data from clinical studies conducted outside of the United States. Additionally, the guidance offers sponsors the option of demonstrating the product’s noninferiority or superiority to standard therapies.

For the purposes of the recommendations, the agency defines an artifical pancreas as including:

Glucose monitoring devices.
A control algorithm.
Infusion pump.
Components and accessories, such as a power cord or wireless controller.
A network, defined as any device or system that physically or wirelessly connects to the artifical pancreas delivery system.

In June, the FDA issued draft guidance regarding nonclinical and clinical trials of the artificial pancreas, called the low glucose suspend system. Comments on this device, particularly those that addressed a treat-to-range system that would adjust insulin dosing if a patient’s glucose level approaches a low or high threshold and a treat-to-target system that would set target glucose levels and try to achieve these levels at all times, influenced the guidance issued today, according to the press release.

To see the full document, please visit http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM281716.pdf.

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