[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]



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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).


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    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