CHICAGO, (Reuters) – The U.S. Food and Drug Administration issued new guidelines to medical device makers developing a potentially revolutionary device for type 1 diabetes, saying they should speed its delivery to patients.
The guidelines reflect months of behind-the-scenes negotiations with patient advocates, medical device makers and researchers working to develop an artificial pancreas — a complex system of pumps and sensors aimed at automating the care and treatment of type 1 diabetes.
Diabetes advocates had feared the FDA would set the bar too high, making regulations so cumbersome that it would delay access to diabetics in the United States.
“This guidance was developed in a way to account for innovation,” Charles “Chip” Zimliki, who heads an FDA initiative to speed up availability of an artificial pancreas, told Reuters in a telephone interview.
He said the new draft guidance gives researchers and medical device makers a clear set of requirements for approving clinical trials that can show the technology is safe in real-world settings.
“We’re showing them a path that I think can get them to a safe and effective product in the U.S.,” he said.
The devices are meant to help the 3 million Americans with type 1 diabetes, a disease in which the immune system destroys cells in the pancreas that make insulin.
Patients must monitor their blood sugar and inject themselves with insulin throughout the day to prevent diabetic complications such as blindness, and heart and kidney disease.
An artificial pancreas would continuously monitor blood glucose levels and automatically deliver the right amount of insulin to the body when it was needed. But the potential for malfunction of these complex devices to cause serious harm raises the stakes for proving their safety.
“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,” said Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health.
