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Insulin Pump Secondary Display

Page Type
Product Code
Definition
The purpose of the insulin pump secondary display is to notify another person of the patient's insulin pump usage information in real time. The secondary display is intended for providing secondary notification of insulin pump usage and does not replace primary real time insulin pump monitoring or standard home blood glucose monitoring.
Physical State
Typically a software device installed on a third-party mobile device, or implemented in a web-based platform.
Technical Method
Receives and displays real-time patient data from an insulin pump.
Target Area
n/a
Regulation Medical Specialty
Chemistry
Review Panel
Chemistry
Submission Type
510(K) Exempt
Device Classification
Class 2
Regulation Number
862.1350
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 862.1350 Continuous glucose monitor secondary alarm system

§ 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]

Insulin Pump Secondary Display

Page Type
Product Code
Definition
The purpose of the insulin pump secondary display is to notify another person of the patient's insulin pump usage information in real time. The secondary display is intended for providing secondary notification of insulin pump usage and does not replace primary real time insulin pump monitoring or standard home blood glucose monitoring.
Physical State
Typically a software device installed on a third-party mobile device, or implemented in a web-based platform.
Technical Method
Receives and displays real-time patient data from an insulin pump.
Target Area
n/a
Regulation Medical Specialty
Chemistry
Review Panel
Chemistry
Submission Type
510(K) Exempt
Device Classification
Class 2
Regulation Number
862.1350
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 862.1350 Continuous glucose monitor secondary alarm system

§ 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]