The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems: Guidance for Industry and Food and Drug Administration Staff
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
November 9, 2012
February 28, 2020
692e0ca7-0e58-43e0-92f6-1f2f471e307d
Related Documents
Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices: Guidance for Industry and Food and Drug Administration Staff
Guidance DocumentFebruary 21, 2023Center for Devices and Radiological Health
Display Devices for Diagnostic Radiology: Guidance for Industry and Food and Drug Administration Staff
Guidance DocumentSeptember 28, 2022Center for Devices and Radiological Health
Investigational Device Exemptions (IDEs) for Devices Indicated for Nocturnal Home Hemodialysis: Guidance for Industry and FDA Staff
Guidance DocumentApril 15, 2008Center for Devices and Radiological Health
Quick Actions
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust GKS for their regulatory compliance needs.
Try KeyPedia Today
Explore our real use cases and discover our features in depth.
Subscribe to our newsletter
Get the latest updates and insights delivered to your inbox