FDA Product Code QJI: Interoperable Automated Glycemic Controller

FDA product code QJI covers interoperable automated glycemic controllers — a key component of closed-loop insulin delivery systems for diabetes management.

These software-based controllers automatically calculate and adjust insulin doses based on continuous glucose monitoring data, implementing a control algorithm that mimics the function of a healthy pancreas. They represent the "brain" of automated insulin delivery systems, also known as artificial pancreas technology.

QJI devices are Class II medical devices, regulated under 21 CFR 862.1356 and reviewed by the FDA Chemistry panel.

Leading manufacturers include Tandem Diabetes Care, Inc., Insulet Corporation and Beta Bionics, Inc..