FDA Releases Draft Guidance for Artificial Pancreas Medical Device Development

The path being taken by several medical device companies towards the development of a viable artificial pancreas became a little smoother this past June with the release of a Draft Guidance document by the FDA concerning IDE and pre-market applications for Low Glucose Suspend (LGS) Device  systems. Artificial pancreas research has been a challenge to the medical device community for decades, but recent breakthroughs have helped the FDA develop a strategy for moving forward with the regulatory aspects of a closed-loop insulin delivery system.

Entitled “The Content of Investigational Device Exemption (IDE) and Premarket Applications for Low Glucose Suspend (LGS) Device Systems,” the FDA document goes into detail about Low Glucose Suspend systems, which can help regulate glucose drops in diabetic patients by limiting the amount of insulin introduced by automated insulin pumps. These systems, which are designed to work in concert with the self-monitoring of glucose levels, represent the cutting edge of what is currently available in the artificial pancreas field.

By providing the document, the FDA hopes to give medical device developers useful information concerning the types of data, outcomes and studies that will be needed to bring these types of glucose control systems to market. The FDA’s decision to outline its regulatory expectations clarifies some of the uncertainty that has hovered over the artificial pancreas field and indicates that the Administration is serious about prioritizing the development of this type of diabetes treatment. It also indicates that the FDA is looking for input from medical device companies and researchers concerning the next step forward in making these types of insulin delivery systems available to the public. In fact, the FDA plans on introducing a second Draft Guidance document by the end of 2011 that further expands on the potential for artificial pancreas development.

MDCI will continue to monitor any and all progress concerning the issues associated with artificial pancreas devices and report on the most important news affecting medical device companies operating in this field of research.

Benjamin Hunting
MDCI Blogging Team