FDA's Efforts to Advance Artificial Pancreas Device Systems
The FDA supports and fosters medical device innovation as it upholds its mission of ensuring that medical devices are safe and effective. The FDA is helping advance the development of an artificial pancreas device system, an innovative device that automatically monitors blood glucose and provides appropriate insulin doses in people with diabetes who use insulin.
Sometimes an artificial pancreas device system is referred to as a "closed-loop" system, an "automated insulin delivery" system, or an "autonomous system for glycemic control." NOTE: The Artificial Pancreas Device Systems described on this site do not involve biomaterial, synthetic or artificial tissue or organs.
The FDA has been working together with diabetes patient groups, diabetes care providers, medical device manufactures, and researchers to advance the development of an artificial pancreas. FDA's efforts include prioritizing the review of research protocol studies, providing clear guidelines to industry, setting performance and safety standards, fostering discussions between government and private researchers, sponsoring public forums, and finding ways to shorten study and review time.
There have been tremendous strides made in the research and development of an Artificial Pancreas Device System. On September 28, 2016, the FDA approved the first hybrid closed loop system, the Medtronic's MiniMed 670G System, intended to automatically monitor blood sugar and adjust basal insulin doses in people with type 1 diabetes. There are also many research projects underway looking at the feasibility of these device systems in hospital settings. For more information on these and other clinical trials, visit www.clinicaltrials.gov.
On this Artificial Pancreas Device Systems website, you can learn more about what an artificial pancreas device system is, research challenges associated with its development, and the FDA's ongoing commitment to a safe and effective artificial pancreas device system for patients with diabetes.
- Federal Register: Final Guidance for Industry and the Food and Drug Administration Staff: The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems (PDF - 847KB)
- Publication: FDA's Proactive Role in the Development of an Artificial Pancreas for the Treatment of Diabetes Mellitus
Webcast of the Meeting Detailed Account of the Meeting
- Latest information for current clinical trials