Artificial Pancreas - FDA Provides Options For Designs And Studies

A draft guidance to help artificial pancreas researchers and makers as they create and submit their devices for FDA approval has been issued by the Agency. Artificial pancreases are currently being designed and created for the treatment of diabetes type 1.The draft guidance provides flexible recommendations for the design and testing of devices so that they can still meet regulatory requirements for efficacy and safety. An example is a flexible choice of study endpoints, how many patients can be involved in the study, and how long the clinical trial can be UGG Classic Cardy Boots .Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health, 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. 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."