Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Integrated Continuous Glucose Monitoring System

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The Food and Drug Administration (FDA, Agency, or we) is classifying the integrated continuous glucose monitoring system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the integrated continuous glucose monitoring system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.