§ 862.1350 - Continuous glucose monitor secondary alarm system.

§ 862.1350 Continuous glucose monitor secondary displayalarm system.

(a) Identification. A continuous glucose monitor (CGM) secondary display alarm system is identified as a device intended to be used for passive real-time monitoring of continuous glucose monitoring data. It must not be capable of serving as a stand-alone primary display device. The primary display device, which is not a part of the continuous glucose monitor secondary display, directly receives the glucose data (for example, it communicates directly with transmitter) from the continuous glucose meter, which is not a part of the continuous glucose monitor secondary display, and is the primary means of viewing the continuous glucose monitor data and alerting the patient to a low or high glucose value. A continuous glucose monitor secondary display can be used by caregivers of people with diabetes to monitor a person's continuous glucose monitoring data. A device is not a continuous glucose monitor secondary display if the data from the primary display device is modified (for example, predicting future glucose values) or the patient can use the secondary display in lieu of a primary display device (for example, the primary display device is blinded or the primary display does not have to be near the person wearing the sensor and transmitter)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]