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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2019.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2019]
[CITE: 21CFR862.1350]
See Related Information on Continuous glucose monitor secondary display. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES

PART 862 -- CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

Subpart B--Clinical Chemistry Test Systems

Sec. 862.1350 Continuous glucose monitor secondary display.

(a) Identification. A continuous glucose monitor secondary display 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).

(b) Classification. Class II (special controls). 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]

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