The FDA issued new guidelines on Thursday for the development of a potentially revolutionary device to treat type 1 diabetes that will give manufacturers 'maximum flexibility' in getting it to U.S. patients (Draft Guidance for Industry and Food and Drug Administration Staff - The Content of Investigational Device Exemption (IDE) and Premarket Applications for Artificial Pancreas Device Systems).
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.
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