Business · 06/12/2011Updated: 10/17/2026 · 1 min read
FDA Releases Draft Guidance for Artificial Pancreas Device Systems
Summary
The Food and Drug Administration (FDA) has made available a draft guidance document outlining the content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) applications for artificial pancreas device systems, specifically the Control-to-Range (CTR) and Control-to-Target (CTT) device systems.
Original source language: Federal Register — Health and Human ServicesOpen original release →