(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.”