The US Food and Drug Administration (FDA) has released a long-awaited final guidance for industry regarding the development of artificial pancreas device systems (APDS), part of a broader effort it hopes will spur the creation of devices capable of monitoring blood glucose levels and automatically administer appropriate amounts of insulin to type one diabetic patients.
Regulators first announced its APDS development initiative in December 2011, touting the release of related draft guidance in a press release-a rare occurrence for any guidance, let alone one in draft form.
"The FDA is focused on improving the process for the study and approval of artificial pancreas systems, and developed this guidance to provide maximum flexibility to manufacturers seeking to bring this device to U.S. patients," said Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health (CDRH) in a statement at the time. "We understand how this device could change the lives of millions of Americans with diabetes, and we want our safety and effectiveness review to give patients the confidence that the device works."
The devices, as envisioned by FDA, would combine two types of medical devices: an insulin pump and a continuous glucose monitor. "While note a cure," explained FDA, "an artificial pancreas could reduce dangerous high and low blood sugars, providing a better quality of life for those with diabetes and lowering the risk for future diabetes-related complications."
Still, the devices are still a few years off by FDA's estimation. "Due to the evolving nature of these device systems, it is expected that they will develop incrementally," it says in its guidance document.
'Flexibility' the Focus of Guidance
To help sponsors along, FDA explained that the guidance seeks to adhere to what it calls a "least burdensome principle," supporting development through a flexible approach that allows many-instead of a one-size fits all-approaches to clinical trials and trial endpoints.
Four other areas of flexibility were identified by regulators: the use of continuous glucose monitor data to evaluate device performance, which may replace the need for periodic manual testing; pre-packaged endpoint and indication combinations most likely to lead to early approvals; a clinical study progression aimed at expediting approval; and flexible study sizes and durations aimed at making trials smaller and shorter by focusing on the parts of devices that are novel, as opposed to what has already been approved.
"We believe the recommendations contained in this guidance will afford Sponsors the flexibility they need to design innovative, safe and effective systems to treat diabetes mellitus," wrote FDA. "We would like to emphasize, that if you believe an alternative, less burdensome approach to investigating APDSs and developing premarket applications for these devices can satisfy regulatory requirements for investigation and approval of APDSs, we encourage you to discuss that approach with the FDA."
The guidance, The Content of Investigational Device Exemption (IDE) and Premarket Approval PMA) Applications for Artificial Pancreas Device Systems, may be found on FDA's website.