FDA Information on Artificial Pancreas Systems

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FDA just posted this guidance to manufacturers of artificial pancreas systems (CGM plus pump) to describe what they expect to see in a premarket approval application before these devices can be approved for marketing in the U.S…

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ConsumerProducts/ArtificialPancreas/default.htm