Title 21

SECTION 862.2120

862.2120 Continuous glucose monitor data management system.

§ 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]

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