Document ID: FDA-2021-N-0660-0001
Agency: fda
Document Type: Rule
Title: Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Interoperable Automated Glycemic Controller
Posted Date: 2022-03-14T04:00Z

[Federal Register Volume 87, Number 49 (Monday, March 14, 2022)]
[Rules and Regulations]
[Pages 14171-14174]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-05303]

[[Page 14171]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 862

[Docket No. FDA-2021-N-0660]

Medical Devices; Clinical Chemistry and Clinical Toxicology 
Devices; Classification of the Interoperable Automated Glycemic 
Controller

AGENCY: Food and Drug Administration, HHS.

ACTION: Final amendment; final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying 
the interoperable automated glycemic controller 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 interoperable automated glycemic controller'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.

DATES: This order is effective March 14, 2022. The classification was 
applicable on December 13, 2019.

FOR FURTHER INFORMATION CONTACT: Joshua Balsam, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 3530, Silver Spring, MD 20993-0002, 240-402-6521, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the interoperable automated 
glycemic controller 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, 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 established the first procedure for De Novo classification 
(Pub. L. 105-115). Section 607 of the Food and Drug Administration 
Safety and Innovation Act modified the De Novo application process by 
adding a second procedure (Pub. L. 112-144). 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 within 
class III, the De Novo classification is considered to be the initial 
classification of the device.
    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 in order 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 July 15, 2019, FDA received Tandem Diabetes Care, Inc.'s request 
for De Novo classification of the Control-IQ Technology. 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 December 13, 2019, FDA issued an order to the 
requester classifying the device into class II. In this final order, 
FDA is codifying the classification of the device by adding 21 CFR 
862.1356.\1\ We have named the generic type of device interoperable 
automated glycemic controller, and it is identified as a device 
intended to automatically calculate drug doses based on inputs such as 
glucose and other relevant physiological parameters, and to command the 
delivery of such drug doses from a connected infusion pump. 
Interoperable automated glycemic controllers are designed to reliably 
and securely communicate with digitally connected devices to allow drug 
delivery commands to be sent, received, executed, and confirmed. 
Interoperable automated glycemic controllers are intended to be used in

[[Page 14172]]

conjunction with digitally connected devices for the purpose of 
maintaining glycemic control.
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    \1\ FDA notes that the ``ACTION'' caption for this final order 
is styled as ``Final amendment; final order,'' rather than ``Final 
order.'' Beginning in December 2019, this editorial change was made 
to indicate that the document ``amends'' the Code of Federal 
Regulations. The change was made in accordance with the Office of 
Federal Register's (OFR) interpretations of the Federal Register Act 
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and 
parts 21 and 22), and the Document Drafting Handbook.
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    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.

     Table 1--Interoperable Automated Glycemic Controller Risks and
                           Mitigation Measures
------------------------------------------------------------------------
            Identified risks                   Mitigation measures
------------------------------------------------------------------------
Patient harm due to inappropriate drug   Clinical data demonstrating
 delivery.                                device performance, Certain
                                          software validation testing,
                                          User training plan, and
                                          Certain drug compatibility
                                          information in labeling.
Risk due to poorer or different          Clinical data demonstrating
 performance in pediatric populations.    device performance in
                                          pediatric population; and
                                          Certain contraindications,
                                          warning statements, and
                                          precautions in labeling.
Risk due to the inability of the         Clinical data demonstrating
 controller to handle different           device performance, Drug
 pharmacokinetic/pharmacodynamic          compatibility information in
 characteristics of the drugs.            labeling, User training plan,
                                          and Human factors testing.
Risk due to lack of compatibility of     Certain validation of
 connected devices.                       communication specifications,
                                          processes, and procedures with
                                          digitally connected devices;
                                          and Limitations on
                                          interoperable devices.
Risk of connected devices having         Specifications for performance
 inadequate performance to allow safe     of connected devices; Certain
 use of the controller.                   validation of communication
                                          specifications, processes, and
                                          procedures with digitally
                                          connected devices; and
                                          Limitations on interoperable
                                          devices.
Failure to report device malfunctions    Plans and procedures for
 or adverse events to the device          assigning postmarket
 manufacturer.                            responsibilities.
Risk of latent flaws in software.......  Robust software validation
                                          testing; Certain validation of
                                          communication specifications,
                                          processes, and procedures with
                                          digitally connected devices;
                                          and Certain verification and
                                          validation of risk control
                                          measures.
Failure to provide appropriate           Certain verification and
 treatment due to loss of communication   validation of risk control
 with connected devices.                  measures; and Certain
                                          validation of communication
                                          specifications, processes, and
                                          procedures with digitally
                                          connected devices.
Risk due to insecure transmission of     Certain validation of
 data.                                    communication specifications,
                                          processes, and procedures with
                                          digitally connected devices.
Failure to correctly operate the device  Human factors testing, User
                                          training plan, Compatible
                                          devices listed in labeling,
                                          and Certain warning statements
                                          and precautions in labeling.
Failure to correctly determine the root  Certain verification and
 cause of device malfunctions.            validation of logging
                                          capability.
Risk due to data transmission            Certain verification and
 interference/electromagnetic             validation of electrical
 disturbance.                             safety, electromagnetic
                                          compatibility, and radio
                                          frequency wireless testing.
------------------------------------------------------------------------

    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).

III. Analysis of Environmental Impact

    The Agency has 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. 3501-3521). 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 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 regulation, have been approved under OMB 
control number 0910-0073; and the collections of information in 21 CFR 
part 801 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.  862.1356 to subpart B to read as follows:

Sec.  862.1356  Interoperable automated glycemic controller.

    (a) Identification. An interoperable automated glycemic controller 
is a device intended to automatically calculate drug doses based on 
inputs such as glucose and other relevant physiological parameters, and 
to command the delivery of such drug doses from a connected infusion 
pump. Interoperable automated glycemic controllers are designed to 
reliably and securely communicate with digitally connected devices to 
allow drug delivery commands to be sent, received, executed, and 
confirmed. Interoperable automated glycemic controllers are

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intended to be used in conjunction with digitally connected devices for 
the purpose of maintaining glycemic control.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Design verification and validation must include:
    (i) An appropriate, as determined by FDA, clinical implementation 
strategy, including data demonstrating appropriate, as determined by 
FDA, clinical performance of the device for its intended use, including 
all of its indications for use.
    (A) The clinical data must be representative of the performance of 
the device in the intended use population and in clinically relevant 
use scenarios and sufficient to demonstrate appropriate, as determined 
by FDA, clinical performance of the device for its intended use, 
including all of its indications for use.
    (B) For devices indicated for use with multiple therapeutic agents 
for the same therapeutic effect (e.g., more than one type of insulin), 
data demonstrating performance with each product or, alternatively, an 
appropriate, as determined by FDA, clinical justification for why such 
data are not needed.
    (C) When determined to be necessary by FDA, the strategy must 
include postmarket data collection to confirm safe real-world use and 
monitor for rare adverse events.
    (ii) Results obtained through a human factors study that 
demonstrates that an intended user can safely use the device for its 
intended use.
    (iii) A detailed and appropriate, as determined by FDA, strategy to 
ensure secure and reliable means of data transmission with other 
intended connected devices.
    (iv) Specifications that are appropriate, as determined by FDA, for 
connected devices that shall be eligible to provide input to (e.g., 
specification of glucose sensor performance) or accept commands from 
(e.g., specifications for drug infusion pump performance) the 
controller, and a detailed strategy for ensuring that connected devices 
meet these specifications.
    (v) Specifications for devices responsible for hosting the 
controller, and a detailed and appropriate, as determined by FDA, 
strategy for ensuring that the specifications are met by the hosting 
devices.
    (vi) Documentation demonstrating that appropriate, as determined by 
FDA, measures are in place (e.g., validated device design features) to 
ensure that safe therapy is maintained when communication with 
digitally connected devices is interrupted, lost, or re-established 
after an interruption. Validation testing results must demonstrate that 
critical events that occur during a loss of communications (e.g., 
commands, device malfunctions, occlusions, etc.) are handled and logged 
appropriately during and after the interruption to maintain patient 
safety.
    (vii) A detailed plan and procedure for assigning postmarket 
responsibilities including adverse event reporting, complaint handling, 
and investigations with the manufacturers of devices that are digitally 
connected to the controller.
    (2) Design verification and validation documentation must include 
appropriate design inputs and design outputs that are essential for the 
proper functioning of the device that have been documented and include 
the following:
    (i) Risk control measures to address device system hazards;
    (ii) Design decisions related to how the risk control measures 
impact essential performance; and
    (iii) A traceability analysis demonstrating that all hazards are 
adequately controlled and that all controls have been validated in the 
final device design.
    (3) The device shall include appropriate, as determined by FDA, and 
validated interface specifications for digitally connected devices. 
These interface specifications shall, at a minimum, provide for the 
following:
    (i) Secure authentication (pairing) to connected devices;
    (ii) Secure, accurate, and reliable means of data transmission 
between the controller and connected devices;
    (iii) Sharing of necessary state information between the controller 
and any connected devices (e.g., battery level, reservoir level, sensor 
use life, pump status, error conditions);
    (iv) Ensuring that the controller continues to operate safely when 
data is received in a manner outside the bounds of the parameters 
specified;
    (v) A detailed process and procedures for sharing the controller's 
interface specification with connected devices and for validating the 
correct implementation of that protocol; and
    (vi) A mechanism for updating the controller software, including 
any software that is required for operation of the controller in a 
manner that ensures its safety and performance.
    (4) The device design must ensure that a record of critical events 
is stored and accessible for an adequate period to allow for auditing 
of communications between digitally connected devices, and to 
facilitate the sharing of pertinent information with the responsible 
parties for those connected devices. Critical events to be stored by 
the controller must, at a minimum, include:
    (i) Commands issued by the controller, and associated confirmations 
the controller receives from digitally connected devices;
    (ii) Malfunctions of the controller and malfunctions reported to 
the controller by digitally connected devices (e.g., infusion pump 
occlusion, glucose sensor shut down);
    (iii) Alarms and alerts and associated acknowledgements from the 
controller as well as those reported to the controller by digitally 
connected devices; and
    (iv) Connectivity events (e.g., establishment or loss of 
communications).
    (5) The device must only receive glucose input from devices cleared 
under Sec.  862.1355 (integrated continuous glucose monitoring system), 
unless FDA determines an alternate type of glucose input device is 
designed appropriately to allow the controller to meet the special 
controls contained within this section.
    (6) The device must only command drug delivery from devices cleared 
under Sec.  880.5730 of this chapter (alternate controller enabled 
infusion pump), unless FDA determines an alternate type of drug 
infusion pump device is designed appropriately to allow the controller 
to meet the special controls contained within this section.
    (7) An appropriate, as determined by FDA, training plan must be 
established for users and healthcare providers to assure the safety and 
performance of the device when used. This may include, but not be 
limited to, training on device contraindications, situations in which 
the device should not be used, notable differences in device 
functionality or features compared to similar alternative therapies, 
and information to help prescribers identify suitable candidate 
patients, as applicable.
    (8) The labeling required under Sec.  809.10(b) of this chapter 
must include:
    (i) A contraindication for use in pediatric populations except to 
the extent clinical performance data or other available information 
demonstrates that it can be safely used in pediatric populations in 
whole or in part.
    (ii) A prominent statement identifying any populations for which 
use of this device has been determined to be unsafe.
    (iii) A prominent statement identifying by name the therapeutic 
agents that are compatible with the controller, including their 
identity and concentration, as appropriate.

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    (iv) The identity of those digitally connected devices with which 
the controller can be used, including descriptions of the specific 
system configurations that can be used, per the detailed strategy 
submitted under paragraph (b)(1)(iii) of this section.
    (v) A comprehensive description of representative clinical 
performance in the hands of the intended user, including information 
specific to use in the pediatric use population, as appropriate.
    (vi) A comprehensive description of safety of the device, 
including, for example, the incidence of severe hypoglycemia, diabetic 
ketoacidosis, and other relevant adverse events observed in a study 
conducted to satisfy paragraph (b)(1)(i) of this section.
    (vii) For wireless connection enabled devices, a description of the 
wireless quality of service required for proper use of the device.
    (viii) For any controller with hardware components intended for 
multiple patient reuse, instructions for safely reprocessing the 
hardware components between uses.

    Dated: March 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-05303 Filed 3-11-22; 8:45 am]
BILLING CODE 4164-01-P