[Federal Register Volume 82, Number 48 (Tuesday, March 14, 2017)]
[Rules and Regulations]
[Pages 13549-13550]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-04940]



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 Rules and Regulations
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  Federal Register / Vol. 82, No. 48 / Tuesday, March 14, 2017 / Rules 
and Regulations  

[[Page 13549]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 862

[Docket No. FDA-2017-N-1141]


Medical Devices; Clinical Chemistry and Clinical Toxicology 
Devices; Classification of the Continuous Glucose Monitor Secondary 
Display

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is classifying the 
continuous glucose monitor secondary display into class II (special 
controls). The special controls that will apply to the device are 
identified in this order and will be part of the codified language for 
the continuous glucose monitor secondary display's classification. The 
Agency is classifying the device into class II (special controls) in 
order to provide a reasonable assurance of safety and effectiveness of 
the device.

DATES: This order is effective March 14, 2017. The classification was 
applicable on January 23, 2015.

FOR FURTHER INFORMATION CONTACT: Ryan Lubert, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4545, Silver Spring, MD 20993-0002, 240-402-6357, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were 
not in commercial distribution before May 28, 1976 (the date of 
enactment of the Medical Device Amendments of 1976), generally referred 
to as postamendments devices, are classified automatically by statute 
into class III without any FDA rulemaking process. These devices remain 
in class III and require premarket approval unless and until the device 
is classified or reclassified into class I or II, or FDA issues an 
order finding the device to be substantially equivalent, in accordance 
with section 513(i) of the FD&C Act, to a predicate device that does 
not require premarket approval. The Agency determines whether new 
devices are substantially equivalent to predicate devices by means of 
premarket notification procedures in section 510(k) of the FD&C Act (21 
U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.
    Section 513(f)(2) of the FD&C Act, also known as De Novo 
classification, as amended by section 607 of the Food and Drug 
Administration Safety and Innovation Act (Pub. L. 112-144), provides 
two procedures by which a person may request FDA to classify a device 
under the criteria set forth in section 513(a)(1). Under the first 
procedure, the person submits a premarket notification under section 
510(k) of the FD&C Act for a device that has not previously been 
classified and, within 30 days of receiving an order classifying the 
device into class III under section 513(f)(1) of the FD&C Act, the 
person requests a classification under section 513(f)(2). Under the 
second procedure, rather than first submitting a premarket notification 
under section 510(k) of the FD&C Act and then a request for 
classification under the first procedure, the person determines that 
there is no legally marketed device upon which to base a determination 
of substantial equivalence and requests a classification under section 
513(f)(2) of the FD&C Act. If the person submits a request to classify 
the device under this second procedure, FDA may decline to undertake 
the classification request if FDA identifies a legally marketed device 
that could provide a reasonable basis for review of substantial 
equivalence with the device or if FDA determines that the device 
submitted is not of ``low-moderate risk'' or that general controls 
would be inadequate to control the risks and special controls to 
mitigate the risks cannot be developed.
    In response to a request to classify a device under either 
procedure provided by section 513(f)(2) of the FD&C Act, FDA shall 
classify the device by written order within 120 days. This 
classification will be the initial classification of the device.
    On December 15, 2014, Dexcom Inc., submitted a request for 
classification of the Dexcom Share Direct Secondary Displays under 
section 513(f)(2) of the FD&C Act.
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed 
the request in order to classify the device under the criteria for 
classification set forth in section 513(a)(1) of the FD&C Act. FDA 
classifies devices into class II if general controls by themselves are 
insufficient to provide reasonable assurance of safety and 
effectiveness, but there is sufficient information to establish special 
controls to provide reasonable assurance of the safety and 
effectiveness of the device for its intended use. After review of the 
information submitted in the request, FDA determined that the device 
can be classified into class II with the establishment of special 
controls. FDA believes these special controls, in addition to general 
controls, will provide reasonable assurance of the safety and 
effectiveness of the device.
    Therefore, on January 23, 2015, FDA issued an order to the 
requestor classifying the device into class II. FDA is codifying the 
classification of the device by adding 21 CFR 862.1350.
    Following the effective date of this final classification order, 
any firm submitting a premarket notification (510(k)) for a continuous 
glucose monitor secondary display will need to comply with the special 
controls named in this final administrative order. A De Novo 
classification decreases regulatory burdens. When FDA classifies a 
device type as class I or II via the De Novo pathway, other 
manufacturers do not have to submit a De Novo request or PMA in order 
to market the same type of device, unless the device has a new intended 
use or technological characteristics that raise different questions of 
safety or effectiveness. Instead, manufacturers can use the less 
burdensome pathway of 510(k), when necessary, to market their device, 
and the device that was the subject of the original De Novo 
classification can serve as a predicate device for additional 510(k)s 
from other manufacturers.
    The device is assigned the generic name continuous glucose monitor 
secondary display, and it is identified as

[[Page 13550]]

a device intended to be used for passive real-time monitoring of 
continuous glucose monitoring data. 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).
    FDA has identified the following risks to health associated 
specifically with this type of device and the measures required to 
mitigate these risks:

               Table 1--Continuous Glucose Monitor Secondary Display Risks and Mitigation Measures
----------------------------------------------------------------------------------------------------------------
                      Identified risks                                       Mitigation measures
----------------------------------------------------------------------------------------------------------------
Incorrect glucose value reported on the secondary display    21 CFR 862.1350(b)(1).
 or glucose value missed due to cybersecurity breach.
Treatment recommendations are made based on data presented   21 CFR 862.1350(b)(2).
 by secondary display device.
Individual with diabetes becomes overly reliant on           21 CFR 862.1350(b)(3).
 ``followers'' for monitoring their glucose levels.
----------------------------------------------------------------------------------------------------------------

    FDA believes that the special controls, in combination with the 
general controls, address these risks to health and provide reasonable 
assurance of the safety and effectiveness.
    Section 510(m) of the FD&C Act provides that FDA may exempt a class 
II device from the premarket notification requirements under section 
510(k), if FDA determines that premarket notification is not necessary 
to provide reasonable assurance of the safety and effectiveness of the 
device. For this type of device, FDA has determined that premarket 
notification is necessary to provide reasonable assurance of the safety 
and effectiveness of the device. Therefore, this device type is not 
exempt from premarket notification requirements. Persons who intend to 
market this type of device must submit to FDA a premarket notification, 
prior to marketing the device, which contains information about the 
continuous glucose monitor secondary display they intend to market.

II. Analysis of Environmental Impact

    We have determined under 21 CFR 25.34(b) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

III. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to 
previously approved collections of information found in other FDA 
regulations. These collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 
part 807, subpart E, regarding premarket notification submissions have 
been approved under OMB control number 0910-0120, and the collections 
of information in 21 CFR parts 801 and 809, regarding labeling have 
been approved under OMB control number 0910-0485.

List of Subjects in 21 CFR Part 862

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
862 is amended as follows:

PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

0
1. The authority citation for part 862 is revised to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  862.1350 to subpart B to read as follows:

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.''

    Dated: March 8, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-04940 Filed 3-13-17; 8:45 am]
 BILLING CODE 4164-01-P