Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Insulin Therapy Adjustment Device, 54873-54875 [2018-23912]
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Federal Register / Vol. 83, No. 212 / Thursday, November 1, 2018 / Rules and Regulations
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 862
[Docket No. FDA–2018–N–3648]
Medical Devices; Clinical Chemistry
and Clinical Toxicology Devices;
Classification of the Insulin Therapy
Adjustment Device
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final order.
The Food and Drug
Administration (FDA or we) is
classifying the insulin therapy
adjustment device into class II (special
controls). The special controls that
apply to the device type are identified
in this order and will be part of the
codified language for the insulin
therapy adjustment device’s
classification. We are taking this action
because we have determined that
classifying the device into class II
(special controls) will provide a
reasonable assurance of safety and
effectiveness of the device. We believe
this action will also enhance patients’
access to beneficial innovative devices,
in part by reducing regulatory burdens.
DATES: This order is effective November
1, 2018. The classification was
applicable on June 12, 2018.
FOR FURTHER INFORMATION CONTACT: Dina
Jerebitski, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4550, Silver Spring,
MD 20993–0002, 301–796–2411,
Dina.Jerebitski@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
amozie on DSK3GDR082PROD with RULES
SUMMARY:
I. Background
Upon request, FDA has classified the
insulin therapy adjustment device as
class II (special controls), which we
have determined will provide a
reasonable assurance of safety and
effectiveness. In addition, we believe
this action will enhance patients’ access
to beneficial innovation, in part by
reducing regulatory burdens by placing
the device into a lower device class than
the automatic class III assignment.
The automatic assignment of class III
occurs by operation of law and without
any action by FDA, regardless of the
level of risk posed by the new device.
Any device that was not in commercial
distribution before May 28, 1976, is
automatically classified as, and remains
within, class III and requires premarket
VerDate Sep<11>2014
20:21 Oct 31, 2018
Jkt 247001
approval unless and until FDA takes an
action to classify or reclassify the device
(see 21 U.S.C. 360c(f)(1)). We refer to
these devices as ‘‘postamendments
devices’’ because they were not in
commercial distribution prior to the
date of enactment of the Medical Device
Amendments of 1976, which amended
the Federal Food, Drug, and Cosmetic
Act (FD&C Act).
FDA may take a variety of actions in
appropriate circumstances to classify or
reclassify a device into class I or II. We
may issue an order finding a new device
to be substantially equivalent under
section 513(i) of the FD&C Act (21
U.S.C. 360c(i)) to a predicate device that
does not require premarket approval.
We determine whether a new device is
substantially equivalent to a predicate
by means of the procedures for
premarket notification under section
510(k) of the FD&C Act (21 U.S.C.
360(k)) and part 807 (21 CFR part 807).
FDA may also classify a device
through ‘‘De Novo’’ classification, a
common name for the process
authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and
Drug Administration Modernization Act
of 1997 (Pub. L. 105–115) established
the first procedure for De Novo
classification. Section 607 of the Food
and Drug Administration Safety and
Innovation Act (Pub. L. 112–144)
modified the De Novo application
process by adding a second procedure.
A device sponsor may utilize either
procedure for De Novo classification.
Under the first procedure, the person
submits a 510(k) for a device that has
not previously been classified. After
receiving an order from FDA classifying
the device into class III under section
513(f)(1) of the FD&C Act, the person
then requests a classification under
section 513(f)(2).
Under the second procedure, rather
than first submitting a 510(k) and then
a request for classification, if the person
determines that there is no legally
marketed device upon which to base a
determination of substantial
equivalence, that person requests a
classification under section 513(f)(2) of
the FD&C Act.
Under either procedure for De Novo
classification, FDA is required to
classify the device by written order
within 120 days. The classification will
be according to the criteria under
section 513(a)(1) of the FD&C Act.
Although the device was automatically
placed within class III, the De Novo
classification is considered to be the
initial classification of the device.
PO 00000
Frm 00013
Fmt 4700
Sfmt 4700
54873
We believe this De Novo classification
will enhance patients’ access to
beneficial innovation, in part by
reducing regulatory burdens. When FDA
classifies a device into class I or II via
the De Novo process, the device can
serve as a predicate for future devices of
that type, including for 510(k)s (see 21
U.S.C. 360c(f)(2)(B)(i)). As a result, other
device sponsors do not have to submit
a De Novo request or premarket
approval application to market a
substantially equivalent device (see 21
U.S.C. 360c(i), defining ‘‘substantial
equivalence’’). Instead, sponsors can use
the less-burdensome 510(k) process,
when necessary, to market their device.
II. De Novo Classification
On August 17, 2017, DreaMed
Diabetes, Ltd., submitted a request for
De Novo classification of the DreaMed
Advisor Pro. 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.
We classify 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 that, in
combination with the general controls,
provide reasonable assurance of the
safety and effectiveness of the device for
its intended use (see 21 U.S.C.
360c(a)(1)(B)). After review of the
information submitted in the request,
we determined that the device can be
classified into class II with the
establishment of special controls. FDA
has determined that these special
controls, in addition to the general
controls, will provide reasonable
assurance of the safety and effectiveness
of the device.
Therefore, on June 12, 2018, FDA
issued an order to the requester
classifying the device into class II. FDA
is codifying the classification of the
device by adding 21 CFR 862.1358. We
have named the generic type of device
insulin therapy adjustment device, and
it is identified as a device intended to
incorporate biological inputs, including
glucose measurement data from a
continuous glucose monitor, to
recommend insulin therapy adjustments
as an aid in optimizing insulin therapy
regimens for patients with diabetes
mellitus.
FDA has identified the following risks
to health associated specifically with
this type of device and the measures
required to mitigate these risks in Table
1.
E:\FR\FM\01NOR1.SGM
01NOR1
54874
Federal Register / Vol. 83, No. 212 / Thursday, November 1, 2018 / Rules and Regulations
TABLE 1—INSULIN THERAPY ADJUSTMENT DEVICE RISKS AND MITIGATION MEASURES
Identified risks
Mitigation measures
Erroneous or extreme changes in insulin dosing recommendations may cause hypoglycemia or hyperglycemia.
Special controls (1) (21 CFR 862.1358(b)(1)), (2) (21
CFR
862.1358(b)(2)),
and
(3)
(21
CFR
862.1358(b)(3)).
Special controls (1) (21 CFR 862.1358(b)(1)) and (3) (21
CFR 862.1358(b)(3)).
Special controls (1) (21 CFR 862.1358(b)(1)), (2) (21
CFR
862.1358(b)(2)),
and
(3)
(21
CFR
862.1358(b)(3)).
Special control (1) (21 CFR 862.1358(b)(1)).
Special control (1) (21 CFR 862.1358(b)(1)).
Incorrect interpretation of results may lead to inappropriate clinical decision making ...
Incorrect understanding of appropriate device use may lead to inappropriate treatment
decisions.
Patient harm due to insecure transmission of data .........................................................
Data corruption may lead to inappropriate treatment recommendations ........................
FDA has determined that special
controls, in combination with the
general controls, address these risks to
health and provide reasonable assurance
of safety and effectiveness. In order for
a device to fall within this classification,
and thus avoid automatic classification
in class III, it would have to comply
with the special controls named in this
final order. The necessary special
controls appear in the regulation
codified by this order. This device is
subject to premarket notification
requirements under section 510(k) of the
FD&C Act.
regulations, have been approved under
OMB control number 0910–0073; and
the collections of information in 21 CFR
parts 801 and 809, regarding labeling,
have been approved under OMB control
number 0910–0485.
III. Analysis of Environmental Impact
PART 862—CLINICAL CHEMISTRY
AND CLINICAL TOXICOLOGY
DEVICES
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.
amozie on DSK3GDR082PROD with RULES
IV. Paperwork Reduction Act of 1995
This final order establishes special
controls that refer to previously
approved collections of information
found in other FDA regulations and
guidance. 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 the
guidance document ‘‘De Novo
Classification Process (Evaluation of
Automatic Class III Designation)’’ have
been approved under OMB control
number 0910–0844; the collections of
information in 21 CFR part 814,
subparts A through E, regarding
premarket approval, have been
approved under OMB control number
0910–0231; the collections of
information in 21 CFR part 807, subpart
E, regarding premarket notification
submissions, have been approved under
OMB control number 0910–0120; the
collections of information in 21 CFR
part 820, regarding quality system
VerDate Sep<11>2014
20:21 Oct 31, 2018
Jkt 247001
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:
1. The authority citation for part 862
continues to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
2. Add § 862.1358 to subpart B to read
as follows:
■
§ 862.1358
device.
Insulin therapy adjustment
(a) Identification. An insulin therapy
adjustment device is a device intended
to incorporate biological inputs,
including glucose measurement data
from a continuous glucose monitor, to
recommend insulin therapy adjustments
as an aid in optimizing insulin therapy
regimens for patients with diabetes
mellitus.
(b) Classification. Class II (special
controls). The special controls for this
device are:
(1) Design verification and validation
must include the following:
(i) A complete description of the
required data inputs, including
timeframe over which data inputs must
be collected and number of data points
required for accurate recommendations;
(ii) A complete description of the
types of device outputs and insulin
therapy adjustment recommendations,
including how the recommendations are
generated;
PO 00000
Frm 00014
Fmt 4700
Sfmt 4700
(iii) Robust data demonstrating the
clinical validity of the device outputs
and insulin therapy recommendations;
(iv) A robust assessment of all input
data specifications, including accuracy
requirements for continuous glucose
monitors and other devices generating
data inputs, to ensure accurate and
reliable therapy adjustment
recommendations. This assessment
must include adequate clinical
justification for each specification;
(v) A detailed strategy to ensure
secure and reliable means of data
transmission to and from the device,
including data integrity checks,
accuracy checks, reliability checks, and
security measures;
(vi) Robust data demonstrating that
users can understand and appropriately
interpret recommendations generated by
the device; and
(vii) An appropriate mitigation
strategy to minimize the occurrence of
dosing recommendation errors, and to
mitigate the risk to patients of any
residual dosing recommendation errors
to a clinically acceptable level.
(2) The device must not be intended
for use in implementing automated
insulin dosing.
(3) Your 21 CFR 809.10(b) labeling
must include:
(i) The identification of specific
insulin formulations that have been
demonstrated to be compatible with use
of the device;
(ii) A detailed description of the
specifications of compatible devices that
provide acceptable input data (e.g.,
continuous glucose monitors, insulin
pumps) used to provide accurate and
reliable therapy adjustment
recommendations;
(iii) A detailed description of all types
of required data (inputs) and dosing
recommendations (outputs) that are
provided by the device; and
(iv) A description of device
limitations, and instructions to prevent
possible disruption of accurate therapy
adjustment recommendations (e.g., time
zone changes due to travel).
E:\FR\FM\01NOR1.SGM
01NOR1
Federal Register / Vol. 83, No. 212 / Thursday, November 1, 2018 / Rules and Regulations
Dated: October 29, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–23912 Filed 10–31–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 862
[Docket No. FDA–2018–N–3694]
Medical Devices; Clinical Chemistry
and Clinical Toxicology Devices;
Classification of the Meprobamate Test
System
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final order.
The Food and Drug
Administration (FDA or we) is
classifying the meprobamate test system
into class II (special controls). The
special controls that apply to the device
type are identified in this order and will
be part of the codified language for the
meprobamate test system’s
classification. We are taking this action
because we have determined that
classifying the device into class II
(special controls) will provide a
reasonable assurance of safety and
effectiveness of the device. We believe
this action will also enhance patients’
access to beneficial innovative devices,
in part by reducing regulatory burdens.
DATES: This order is effective November
1, 2018. The classification was
applicable on April 20, 2018.
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,
Ryan.Lubert@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
amozie on DSK3GDR082PROD with RULES
I. Background
Upon request, FDA has classified the
meprobamate test system as class II
(special controls), which we have
determined will provide a reasonable
assurance of safety and effectiveness. In
addition, we believe this action will
enhance patients’ access to beneficial
innovation, in part by reducing
regulatory burdens by placing the
device into a lower device class than the
automatic class III assignment.
The automatic assignment of class III
occurs by operation of law and without
any action by FDA, regardless of the
VerDate Sep<11>2014
20:21 Oct 31, 2018
Jkt 247001
level of risk posed by the new device.
Any device that was not in commercial
distribution before May 28, 1976, is
automatically classified as, and remains
within, class III and requires premarket
approval unless and until FDA takes an
action to classify or reclassify the device
(see 21 U.S.C. 360c(f)(1)). We refer to
these devices as ‘‘postamendments
devices’’ because they were not in
commercial distribution prior to the
date of enactment of the Medical Device
Amendments of 1976, which amended
the Federal Food, Drug, and Cosmetic
Act (FD&C Act).
FDA may take a variety of actions in
appropriate circumstances to classify or
reclassify a device into class I or II. We
may issue an order finding a new device
to be substantially equivalent under
section 513(i) of the FD&C Act (21
U.S.C. 360c(i)) to a predicate device that
does not require premarket approval.
We determine whether a new device is
substantially equivalent to a predicate
by means of the procedures for
premarket notification under section
510(k) of the FD&C Act (21 U.S.C.
360(k)) and part 807 (21 CFR part 807).
FDA may also classify a device
through ‘‘De Novo’’ classification, a
common name for the process
authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and
Drug Administration Modernization Act
of 1997 (Pub. L. 105–115) established
the first procedure for De Novo
classification. Section 607 of the Food
and Drug Administration Safety and
Innovation Act (Pub. L. 112–144)
modified the De Novo application
process by adding a second procedure.
A device sponsor may utilize either
procedure for De Novo classification.
Under the first procedure, the person
submits a 510(k) for a device that has
not previously been classified. After
receiving an order from FDA classifying
the device into class III under section
513(f)(1) of the FD&C Act, the person
then requests a classification under
section 513(f)(2).
Under the second procedure, rather
than first submitting a 510(k) and then
a request for classification, if the person
determines that there is no legally
marketed device upon which to base a
determination of substantial
equivalence, that person requests a
classification under section 513(f)(2) of
the FD&C Act.
Under either procedure for De Novo
classification, FDA shall classify the
device by written order within 120 days.
The classification will be according to
the criteria under section 513(a)(1) of
the FD&C Act. Although the device was
automatically placed within class III,
the De Novo classification is considered
PO 00000
Frm 00015
Fmt 4700
Sfmt 4700
54875
to be the initial classification of the
device.
We believe this De Novo classification
will enhance patients’ access to
beneficial innovation, in part by
reducing regulatory burdens. When FDA
classifies a device into class I or II via
the De Novo process, the device can
serve as a predicate for future devices of
that type, including for 510(k)s (see 21
U.S.C. 360c(f)(2)(B)(i)). As a result, other
device sponsors do not have to submit
a De Novo request or premarket
approval application to market a
substantially equivalent device (see 21
U.S.C. 360c(i), defining ‘‘substantial
equivalence’’). Instead, sponsors can use
the less-burdensome 510(k) process,
when necessary, to market their device.
II. De Novo Classification
On February 21, 2017, Lin-Zhi
International, Inc. submitted a request
for De Novo classification of the LZI
Carisoprodol Metabolite (Meprobamate)
Enzyme Immunoassay. 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.
We classify 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 that, in
combination with the general controls,
provide reasonable assurance of the
safety and effectiveness of the device for
its intended use (see 21 U.S.C.
360c(a)(1)(B)). After review of the
information submitted in the request,
we determined that the device can be
classified into class II with the
establishment of special controls. FDA
has determined that these special
controls, in addition to the general
controls, will provide reasonable
assurance of the safety and effectiveness
of the device.
Therefore, on April 20, 2018, FDA
issued an order to the requester
classifying the device into class II. FDA
is codifying the classification of the
device by adding 21 CFR 862.3590. We
have named the generic type of device
meprobamate test system, and it is
identified as a device intended to
measure meprobamate in human
specimens. Measurements obtained by
this device are used to detect the
presence of meprobamate to diagnose
the use or overdose of meprobamate or
structurally-related drug compounds
(e.g., prodrugs).
FDA has identified the following risks
to health associated specifically with
this type of device and the measures
E:\FR\FM\01NOR1.SGM
01NOR1
]]>Agencies
[Federal Register Volume 83, Number 212 (Thursday, November 1, 2018)]
[Rules and Regulations]
[Pages 54873-54875]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23912]
[[Page 54873]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 862
[Docket No. FDA-2018-N-3648]
Medical Devices; Clinical Chemistry and Clinical Toxicology
Devices; Classification of the Insulin Therapy Adjustment Device
AGENCY: Food and Drug Administration, HHS.
ACTION: Final order.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the insulin therapy adjustment device into class II (special controls).
The special controls that apply to the device type are identified in
this order and will be part of the codified language for the insulin
therapy adjustment device's classification. We are taking this action
because we have determined that classifying the device into class II
(special controls) will provide a reasonable assurance of safety and
effectiveness of the device. We believe this action will also enhance
patients' access to beneficial innovative devices, in part by reducing
regulatory burdens.
DATES: This order is effective November 1, 2018. The classification was
applicable on June 12, 2018.
FOR FURTHER INFORMATION CONTACT: Dina Jerebitski, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 4550, Silver Spring, MD 20993-0002, 301-
796-2411, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the insulin therapy adjustment
device as class II (special controls), which we have determined will
provide a reasonable assurance of safety and effectiveness. In
addition, we believe this action will enhance patients' access to
beneficial innovation, in part by reducing regulatory burdens by
placing the device into a lower device class than the automatic class
III assignment.
The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that
does not require premarket approval. We determine whether a new device
is substantially equivalent to a predicate by means of the procedures
for premarket notification under section 510(k) of the FD&C Act (21
U.S.C. 360(k)) and part 807 (21 CFR part 807).
FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 (Pub. L. 105-115) established the first procedure for De
Novo classification. Section 607 of the Food and Drug Administration
Safety and Innovation Act (Pub. L. 112-144) modified the De Novo
application process by adding a second procedure. A device sponsor may
utilize either procedure for De Novo classification.
Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
We believe this De Novo classification will enhance patients'
access to beneficial innovation, in part by reducing regulatory
burdens. When FDA classifies a device into class I or II via the De
Novo process, the device can serve as a predicate for future devices of
that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a
result, other device sponsors do not have to submit a De Novo request
or premarket approval application to market a substantially equivalent
device (see 21 U.S.C. 360c(i), defining ``substantial equivalence'').
Instead, sponsors can use the less-burdensome 510(k) process, when
necessary, to market their device.
II. De Novo Classification
On August 17, 2017, DreaMed Diabetes, Ltd., submitted a request for
De Novo classification of the DreaMed Advisor Pro. 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.
We classify 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 that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
Therefore, on June 12, 2018, FDA issued an order to the requester
classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 862.1358. We have named
the generic type of device insulin therapy adjustment device, and it is
identified as a device intended to incorporate biological inputs,
including glucose measurement data from a continuous glucose monitor,
to recommend insulin therapy adjustments as an aid in optimizing
insulin therapy regimens for patients with diabetes mellitus.
FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in Table 1.
[[Page 54874]]
Table 1--Insulin Therapy Adjustment Device Risks and Mitigation Measures
------------------------------------------------------------------------
Identified risks Mitigation measures
------------------------------------------------------------------------
Erroneous or extreme changes in insulin Special controls (1) (21 CFR
dosing recommendations may cause 862.1358(b)(1)), (2) (21 CFR
hypoglycemia or hyperglycemia. 862.1358(b)(2)), and (3) (21
CFR 862.1358(b)(3)).
Incorrect interpretation of results may Special controls (1) (21 CFR
lead to inappropriate clinical decision 862.1358(b)(1)) and (3) (21
making. CFR 862.1358(b)(3)).
Incorrect understanding of appropriate Special controls (1) (21 CFR
device use may lead to inappropriate 862.1358(b)(1)), (2) (21 CFR
treatment decisions. 862.1358(b)(2)), and (3) (21
CFR 862.1358(b)(3)).
Patient harm due to insecure Special control (1) (21 CFR
transmission of data. 862.1358(b)(1)).
Data corruption may lead to Special control (1) (21 CFR
inappropriate treatment recommendations. 862.1358(b)(1)).
------------------------------------------------------------------------
FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. In order for a device to fall
within this classification, and thus avoid automatic classification in
class III, it would have to comply with the special controls named in
this final order. The necessary special controls appear in the
regulation codified by this order. This device is subject to premarket
notification requirements under section 510(k) of the FD&C Act.
III. 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.
IV. Paperwork Reduction Act of 1995
This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. 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 the guidance document ``De Novo Classification
Process (Evaluation of Automatic Class III Designation)'' have been
approved under OMB control number 0910-0844; the collections of
information in 21 CFR part 814, subparts A through E, regarding
premarket approval, have been approved under OMB control number 0910-
0231; the collections of information in 21 CFR part 807, subpart E,
regarding premarket notification submissions, have been approved under
OMB control number 0910-0120; the collections of information in 21 CFR
part 820, regarding quality system regulations, have been approved
under OMB control number 0910-0073; 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 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 862.1358 to subpart B to read as follows:
Sec. 862.1358 Insulin therapy adjustment device.
(a) Identification. An insulin therapy adjustment device is a
device intended to incorporate biological inputs, including glucose
measurement data from a continuous glucose monitor, to recommend
insulin therapy adjustments as an aid in optimizing insulin therapy
regimens for patients with diabetes mellitus.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Design verification and validation must include the following:
(i) A complete description of the required data inputs, including
timeframe over which data inputs must be collected and number of data
points required for accurate recommendations;
(ii) A complete description of the types of device outputs and
insulin therapy adjustment recommendations, including how the
recommendations are generated;
(iii) Robust data demonstrating the clinical validity of the device
outputs and insulin therapy recommendations;
(iv) A robust assessment of all input data specifications,
including accuracy requirements for continuous glucose monitors and
other devices generating data inputs, to ensure accurate and reliable
therapy adjustment recommendations. This assessment must include
adequate clinical justification for each specification;
(v) A detailed strategy to ensure secure and reliable means of data
transmission to and from the device, including data integrity checks,
accuracy checks, reliability checks, and security measures;
(vi) Robust data demonstrating that users can understand and
appropriately interpret recommendations generated by the device; and
(vii) An appropriate mitigation strategy to minimize the occurrence
of dosing recommendation errors, and to mitigate the risk to patients
of any residual dosing recommendation errors to a clinically acceptable
level.
(2) The device must not be intended for use in implementing
automated insulin dosing.
(3) Your 21 CFR 809.10(b) labeling must include:
(i) The identification of specific insulin formulations that have
been demonstrated to be compatible with use of the device;
(ii) A detailed description of the specifications of compatible
devices that provide acceptable input data (e.g., continuous glucose
monitors, insulin pumps) used to provide accurate and reliable therapy
adjustment recommendations;
(iii) A detailed description of all types of required data (inputs)
and dosing recommendations (outputs) that are provided by the device;
and
(iv) A description of device limitations, and instructions to
prevent possible disruption of accurate therapy adjustment
recommendations (e.g., time zone changes due to travel).
[[Page 54875]]
Dated: October 29, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23912 Filed 10-31-18; 8:45 am]
BILLING CODE 4164-01-P
