§ 862.2120. Continuous glucose monitor data management system.
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/us/cfr/t21/s§ 862.2120·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]
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§ 862.2120
Continuous glucose monitor data management system.
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