?Today?s action continues the agency?s ongoing efforts to work with the diabetes community to help ensure the safety and efficacy of innovative and customizable diabetes management systems that may help patients better tailor their treatments to their individual needs,? said Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA?s Center for Devices and Radiological Health. ?The marketing authorization of this first stand-alone interoperable automated glycemic controller also allows substantially equivalent controller technologies that are developed for diabetes in the future to go through the 510(k) review process, helping to promote timely patient access to innovative technologies that can improve their care and quality of life.? Diabetes impairs the body?s ability to make or properly use the blood glucose-regulating hormone insulin and impacts nearly 10% of Americans. In type 1 diabetes, once known as juvenile diabetes, the patient?s pancreas produces little or no insulin. Five percent of patients with diabetes have type 1 diabetes. The Control-IQ Technology controller is a new type of glycemic controller that when used as a system with compatible iCGMs and ACE pumps can be used by patients with type 1 diabetes to automatically increase, decrease and suspend delivery of basal insulin to the patient based on insulin delivery history, iCGM readings and predicted glucose values. The controller can also automatically deliver a specific amount of insulin when the glucose value is predicted to exceed a predefined amount. Other software to automatically control insulin delivery has previously been approved by the FDA as part of a single, predefined diabetes management system (as a class III, high-risk device). The Control-IQ Technology controller, which is designed to communicate with other compatible diabetes device components that are also designed to be integrated into a modular system, was reviewed through the?De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. The FDA reviewed data from a clinical trial of the Control-IQ Technology controller that included 168 participants with type 1 diabetes. Patients were randomized to use either the Control-IQ Technology controller installed on a Tandem t:slim X2 insulin pump, or a CGM and insulin pump without the Control-IQ Technology controller. The study demonstrated that the controller determines and commands safe and effective insulin delivery from a compatible ACE pump based on iCGM readings, with limited user intervention outside of mealtimes. The FDA also assessed the ability of the controller to communicate with all parts of the system with appropriate reliability, cybersecurity and fail-safe modes. Even though the system has been assessed for reliability, incorrect and inappropriate calculation, and command, delay of insulin delivery can still occur. Other risks associated with use of the interoperable controller can include incorrect insulin delivery as a result of loss of communication between connected devices, or from exploitation of cybersecurity vulnerabilities. These associated risks can lead to low blood glucose (hypoglycemia) or high blood glucose (hyperglycemia, including diabetic ketoacidosis). Along with this authorization, the FDA is establishing criteria, called special controls, which outline specific regulatory requirements that, when met along with general controls, provide a reasonable assurance of device safety and effectiveness for devices of this type. For this device, those controls include requirements related to reliability, device interoperability, cybersecurity, and clinical relevance. With the authorization of the interoperable Control-IQ Technology controller and the establishment of these special controls, the FDA has created a new regulatory classification for this type of device, which means that subsequent devices of the same type with the same intended use may go through FDA?s 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device. The FDA granted marketing authorization of the Control-IQ Technology controller to Tandem Diabetes Care Inc. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation?s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

###

---