Guidance for Industry and Food and Drug Administration Staff; The Content of Investigational Device Exemption and Premarket Approval Applications for Artificial Pancreas Device Systems; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems." FDA is issuing this guidance to inform industry and Agency staff of its recommendations for analytical and clinical performance studies to support premarket submissions for artificial pancreas systems.