FDA Product Code QFG: Alternate Controller Enabled Insulin Infusion Pump

Under FDA product code QFG, alternate controller enabled (ACE) insulin infusion pumps are cleared for integration with external automated insulin delivery systems.

These insulin pumps are designed with standardized communication interfaces that allow third-party controllers — including smartphones and closed-loop algorithms — to adjust insulin delivery. They are a key component of artificial pancreas systems that automate glycemic management in diabetes.

QFG devices are Class II medical devices, regulated under 21 CFR 880.5730 and reviewed by the FDA Chemistry panel.

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