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# Class 1 for Continuous Glucose Monitor Data Systems
- URL: https://www.fdaweb.com/class-1-for-continuous-glucose-monitor-data-systems/
- Published: 2019-10-29T12:00:00.000Z
- Updated: 2026-09-15T01:59:42.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5145362

*Federal Register* notice: FDA has classified continuous glucose monitor data management systems into Class 1 (general controls). The classification decision is based on a 2014 Dexcom, Inc.-submitted request for *De Novo* classification of its Studio on the Cloud Data Management Software. FDA has identified the system as an electronic device intended to acquire, process, and correlate retrospective data from a continuous glucose monitoring device. This device is intended to be used by patients or their healthcare providers when determining therapeutic strategies. It notes that a continuous glucose monitor data management system is not a drug dose calculator and does not provide treatment recommendations. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-10-29/pdf/2019-23471.pdf?ref=fdaweb.com).