Class 2 for Automated Glycemic Controllers

Federal Register notice: FDA has classified the interoperable automated glycemic controller into medical device Class 2 (special controls). The action is in response to a Tandem Diabetes Care de novo classification request for its Control-IQ Technology. The agency has identified it as a device intended to automatically calculate drug doses based on inputs such as glucose and other relevant physiological parameters, and to command the delivery of such drug doses from a connected infusion pump. It says interoperable automated glycemic controllers are designed to reliably and securely communicate with digitally connected devices to allow drug delivery commands to be sent, received, executed, and confirmed. They are also to be used in conjunction with digitally connected devices for the purpose of maintaining glycemic control, it says. To view the notice, click here.