The FDA has issued draft guidance to companies that are looking to submit an Investigational Device Exemption (IDE) or premarket approval (PMA) application for an Artificial Pancreas Device System that would be used by patients at home.
The document explains how one should go about proving the safety and effectiveness of an artificial pancreas, although the guidance is clear that these are simply recommendations and that “the word should in Agency guidances means that something is suggested or recommended, but not required.”