21 CFR § 862.1350 - Continuous glucose monitor secondary alarm system.

---
identifier: "/us/cfr/t21/s862.1350"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 862.1350 - Continuous glucose monitor secondary alarm system."
title_number: 21
title_name: "Food and Drugs"
section_number: "862.1350"
section_name: "Continuous glucose monitor secondary alarm system."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "862"
part_name: "CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "52 FR 16122, May 1, 1987, unless otherwise noted."
cfr_part: "862"
---


# 862.1350 Continuous glucose monitor secondary alarm system.

(a) *Identification.* A continuous glucose monitor (CGM) secondary alarm system is identified as a device intended to be used as a secondary alarm for a CGM to enable immediate awareness for potential clinical intervention to help assure patient safety.

(b) *Classification.* Class II (special 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. The special controls for this device are:

(1) Devices being marketed must include appropriate measures to protect against unauthorized access to data and unauthorized modification of data.

(2) The labeling must prominently and conspicuously display a warning that states “Dosing decisions should not be made based on this device. The user should follow instructions on the continuous glucose monitoring system.”

(3) The labeling for the device must include a statement that reads “This device is not intended to replace self-monitoring practices as advised by a physician.”

[82 FR 13550, Mar. 14, 2017, as amended at 84 FR 71796, Dec. 30, 2019; 86 FR 20283, Apr. 19, 2021]