FDA’s Efforts to Advance Artificial Pancreas Device Systems and the Challenges Ahead
The FDA is helping advance the development of an artificial pancreas device system (APDS)—an innovative device that automatically monitors blood glucose and provides appropriate insulin doses in people with diabetes who use insulin.
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.
FDA’s release of 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 will help provide clarity for manufacturers, investigators and reviewers in the development of this important technology. It allows manufacturers and researchers to be innovative and flexible in how they develop studies. It also promotes greater communication between the FDA and manufacturers and researchers, which will support the rapid, safe and effective development of an APDS.
There have been tremendous strides made in the research and development of an APDS, and there are 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 website you can learn more about what an artificial pancreas device system is, research challenges associated with its development, and FDA’s ongoing commitment to a safe and effective artificial pancreas device system for patients with diabetes.
NOTE: The APDS described on this site do not involve biomaterial, synthetic or artificial tissue or organs.
- 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