[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
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
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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.
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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
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Identified risks Mitigation measures
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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.
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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