iCGM Regulatory Standards

Introduction

The FDA is shaping the regulatory landscape for integrated Continuous Glucose Monitoring (iCGM) systems.

Key Events

• In 2018, the FDA cleared the first iCGM system, Dexcom G6 [1].
• By 2020, the FDA updated its guidance, emphasizing interoperability and cybersecurity [2].

Standards and Guidance

Regulatory bodies demand accuracy, reliability, and safety. Manufacturers must comply to get approved.

Conclusion

iCGM regulatory standards protect patient safety and ensure device effectiveness. Updates reflect the field's rapid innovation.