[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]]
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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.
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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.
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Table 1--Insulin Therapy Adjustment Device Risks and Mitigation Measures
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Identified risks Mitigation measures
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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)).
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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