The New Diabetes Device In Town
(BlackDoctor.org) — 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He said the new draft guidance gives researchers and medical device makers a clear set of requirements for approving clinical trials that can show the technology is safe in real-world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.