Working with patient advocates, medical device makers and researchers, the FDA created the set of guidelines on the development and approval of an artificial pancreas, a set of pumps and sensors that monitors glucose levels and automatically releases insulin if needed.
Charles Zimliki, who heads the FDA’s artificial pancreas initiative, told Reuter’s the new draft guidance provides a set of requirements for researchers and medical device makers on clinical trials of the device. The guidelines recommend a three-phase clinical trial series where patients are monitored in the hospital and graduate to real-world settings.
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