---
kind: "section"
citation: "21 C.F.R. § 862.2120"
title: "21"
number: "862.2120"
heading: "Continuous glucose monitor data management system."
url: "https://uscodex.org/cfr/21/862.2120"
---

# §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](/cfr/21/part807-subpartE.md) of this chapter, subject to the limitations in [§ 862.9](/cfr/21/862.9.md).

## Notes

### Amendments

[84 FR 57817, Oct. 29, 2019]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 52 FR 16122, May 1, 1987, unless otherwise noted.

### Amendments

[84 FR 57817, Oct. 29, 2019]