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CGM Accuracy Standards: FDA Class II vs Class III 2024: 95% vs 99%
By Lily Armstrong.
Abstract
CGM accuracy standards differ by FDA class. Class II requires 95% within 15 mg/dL or 15% of reference; Class III demands 99%. Learn what this means for your data. Independent technical note mirroring the canonical version: https://healtho.io/blog/cgm-accuracy-standards-fda-class-ii-vs-class-iii-2024-95-vs-99.php
Keywords
- Diabetes Management and Research
- continuous glucose monitoring
- CGM accuracy
- Class II medical devices
- Class III medical devices
- accuracy standards
- diabetes technology
- Open access