FDA guides novel diabetes device manufacturers towards easier approval

April 28, 2017

???Today's insulin systems are basing all dosing decisions on that monitor, so we need to make sure we test them appropriately,??? said Charles Zimliki, chair of the FDA's Artificial Pancreas Critical Path Initiative said in November. ???An artificial pancreas system could allow people with diabetes, especially children, to live active lives without the constant need to constantly monitor their glucose levels,??? he said in a statement today. ???While not a cure, an artificial pancreas could reduce dangerous high and low blood sugars, providing a better quality of life for those with diabetes and lowering the risk for future diabetes-related complications.??? ???We're showing them a path that I think can get them to a safe and effective product in the U.S.,??? he said.

Patient advocates feared the FDA would take an excessively cautious stance, pointing to requirements issued in June for a very early version of an artificial pancreas device that is already sold in 50 countries but not the United States.

???It was a guidance for a product that had already been approved around the world, had been used by thousands of people with significant positive impact, and the U.S. was significantly behind on that front,??? Aaron Kowalski, lead researcher at the Juvenile Diabetes Research Foundation, told a media briefing.

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