Business · 23/11/2012Updated: 10/17/2026 · 1 min read
FDA Releases Guidance for Artificial Pancreas Device Systems
Summary
The Food and Drug Administration (FDA) has published a guidance document outlining its recommendations for analytical and clinical performance studies to support premarket submissions for artificial pancreas systems, aiming to inform industry and Agency staff on the content of IDE and PMA applications.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →