Minimum requirements for continuous glucose monitors: What does it mean?

Abstract

Keywords

minimum requirement adverse events diabetes continuous glucose monitor

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References

FDA. Premarket Notification 510(k). Date unknown. https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k#whennot.

Mathieu

Irace

Wilmot

, et al. Minimum expectations for market authorization of continuous glucose monitoring devices in Europe—‘eCGM’ compliance status. Diabetes Obes Metab. 2025;27(3):1025-1031. doi:10.1111/dom.16153.

Pleus

Eichenlaub

Eriksson Boija

, et al. Proposed minimum requirements for market approval of continuous glucose monitoring (CGM) systems: a viewpoint from the IFCC working group on CGM [published online ahead of print April 28, 2025]. Diabetes Obes Metab. doi:10.1111/dom.16420.

Integrated continuous glucose monitoring system. Date unknown. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-862/subpart-B/section-862.1355.

Krouwer

. Continuous glucose monitor agreement rates: a questionable metric [published online ahead of print April 24, 2025]. J Diabetes Sci Technol. doi:10.1177/19322968251335934.