The FDA has issued draft guidance for manufacturers developing artificial pancreas devices to treat type 1 diabetes. The guidance recommended design elements and testing procedures that could expedite the approval process while reassuring regulators that corners have not been cut on safety and effectiveness.
The guidance, which was announced in a Dec. 1 and drew broad media coverage, may signal the agency’s willingness to move nimbly when clinical demand for a given technology is especially high and the technology is approaching maturity. In this case, the draft guidance suggested ways sponsors can draw from established safety and effectiveness data for the device's individual components, along with data from clinical studies conducted outside the U.S. It also allows manufacturers their choice of study endpoints, number of patients to study and length of clinical trials.
Meanwhile, according to the U.S. Department of Health and Human Services’ National Diabetes Information Clearinghouse, diabetes affects 25.8 million Americans of all ages.
“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, MD, director of the FDA’s Center for Devices and Radiological Health.
Numerous news outlets noted that the guidance came less than a month after lawmakers, health professionals, advocacy organizations and patients lobbied for expedited approval of the device.
Type 1 diabetes is a chronic condition in which the pancreas produces little or no insulin, the hormone needed to properly control levels of blood sugar. Artificial pancreas systems combine an insulin pump with a continuous glucose monitor (CGM), which tracks glucose levels from a sensor placed under the skin. The pump administers appropriate doses of insulin as determined by a computer algorithm.
“Flexibility is one of the most important hallmarks of this guidance,” Charles L. Zimliki, PhD, leader of the FDA’s Artificial Pancreas Working Groups and Critical Path Initiative, told reporters at a Dec. 2 news conference. “We really wanted to make a push. We want people to move these things forward, and we think this guidance will allow people to get a safe and effective product on the market quickly.”
The FDA said it will soon publish a Federal Register notice to solicit public comments on the draft guidance.