iCGM Regulatory Standards

What is iCGM?

Integrated Continuous Glucose Monitor (iCGM) is an FDA regulatory classification for CGM devices that meet specific accuracy and reliability standards for use with automated insulin delivery systems.

Regulatory Framework

The US FDA regulates iCGM systems as Class III medical devices, requiring:

• Premarket Approval (PMA) or De Novo classification
• Rigorous clinical trials
• Ongoing post-market surveillance

Key Standards Organizations

FDA (US)

Sets the iCGM special controls and performance criteria

International Organization for Standardization (ISO)

Sets global standards for medical device quality and safety

AAMI (Association for the Advancement of Medical Instrumentation)

Develops consensus standards for medical devices

Requirements for iCGM Designation

Manufacturers must demonstrate:

• Accuracy: Specific MARD thresholds
• Reliability: Consistent performance over sensor life
• Safety: Appropriate alerts and fail-safes
• Interoperability: Ability to communicate with other devices

The Importance of Interoperability

iCGM designation allows CGMs to be paired with compatible:

• Insulin pumps (ACE pumps)
• Automated dosing algorithms
• Mobile applications