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Code of Federal Regulations (Last Updated: May 6, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 862 - Clinical Chemistry and Clinical Toxicology Devices |
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Subpart C - Clinical Laboratory Instruments |
§ 862.2120 - Continuous glucose monitor data management system.
Latest version.
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§ 862.2120 Continuous glucose monitor data management system.
(a) Identification. A continuous glucose monitor data management system is 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. A continuous glucose monitor data management system is not a drug dose calculator and does not provide treatment recommendations.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 862.9.
[84 FR 57817, Oct. 29, 2019]