FDA Issues Draft Guidance on Artificial Pancreas Device Systems for Investigational Device Exemption and Premarket Approval Applications

Artificial Pancreas Device Systems (APDS) are devices which can make changes to insulin dosing through software with one or more feedback mechanism, and an insulin pump. The goal of an APDS is to maintain glucose levels at or near a specified target or within a range to minimize the incidence of hypoglycemic and hyperglycemic events. Early systems will likely include the use of a CGM, insulin pump, and control software to achieve this goal. As these systems advance, the system could include multiple sensors, hormones, and control software which will optimize the system for event based control, including eating, exercising, or sleeping.

The FDA recognizes that the development of APDS requires unique guidance as these systems will automate changes in insulin (and possibly other hormone/s) dosing that will have an immediate impact on the patients’ health and safety. JDRF is interested in this guidance as it will have a significant impact on the development of systems in both an academic research setting and for commercial development.

Reference:

“Draft Guidance for Industry and Food and Drug Administration Staff – The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems – Draft Guidance” – Document issued on: December 6, 2011.
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM281716.pdf

Ramifications for Individuals with Type 1 Diabetes:

The use of Artificial Pancreas Device Systems in diabetes management provides the opportunity to improve short and long term patient care and safety while improving quality of life with T1D. The draft guidance attempts to provide clarity to researchers and industry around FDA approval requirements. The appropriate requirements will create an environment where safe and impactful APDS can be developed and delivered to patients in a timely manner. The goal of this guidance would be to provide clear and realistic expectations for the development of artificial pancreas systems.

JDRF Involvement:

JDRF played a seminal role in the development of this draft guidance. In 2010 JDRF gathered a team of top clinicians to draft a set of recommendations, which JDRF submitted to FDA in March 2011. JDRF then called on its volunteers, expert researchers, clinical organizations, and Congress to demonstrate support for the AP guidelines. More than 250 House members and more than 60 U.S. senators sent letters to the FDA calling on the agency to produce timely AP system clinical development guidance. In addition, JDRF worked closely with the major clinical organizations including the American Association of Clinical Endocrinologists, the American Association of Diabetes Educators (AADE), the American Diabetes Association, and The Endocrine Society and they submitted letters to the FDA voicing their support of the JDRF proposal. Currently, JDRF is in the process of soliciting feedback from key opinion leaders in the field of APDS to determine the impact of the draft guidance and determine if clarifications are necessary to allow for the greatest positive impact of the guidance. JDRF will provide a response to the FDA call for comments.