FDA Unveils New Insulin Pump Classification

(t:slim X2. Image courtesy Tandem Diabetes Care.)

The U.S. Food and Drug Administration (FDA) has given its stamp of approval to an insulin pump as a member of a new category called alternate controller enabled (ACE) infusion pumps.

This new classification is based on criteria outlined by the agency concerning a pump’s accuracy, reliability, cybersecurity and clinical relevance to patients. It also requires companies that apply for this designation to submit certain types of data, derived from studies that follow an FDA-approved design.

The first insulin pump to receive the ACE classification is Tandem Diabetes Care’s t:slim X2, as noted in a press release from the company. This classification means that the pump “is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute and confirm commands from these devices.”

The new ACE classification for pumps applies to any device built to infuse drugs (such as insulin) into a patient. In practice, it’s meant to encourage companies to design and build devices for diabetes that communicate seamlessly with one another, allowing doctors and patients to customize the chain of devices that works best for them.

This approach is important because “Diabetes is not a one-size-fits-all disease,” says Aaron Kowalski, PhD, chief mission officer at JDRF, which supports Type 1 diabetes research and education. “The ACE pump classification opens up the potential for more options for people with diabetes and faster innovation. By providing more options, people with diabetes will be able to choose the devices that make their day-to-day life with the disease healthier and easier.”

For more information about the new ACE classification, you can read the FDA’s news release on the topic.

Want to learn more about new diabetes technologies? Read “10 Diabetes Technologies to Watch in 2019.”