Rule2022-05303
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Interoperable Automated Glycemic Controller
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 14, 2022
Effective
March 14, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 49 (Monday, March 14, 2022)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-05303]
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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,
<a href="/cdn-cgi/l/email-protection#b7fdd8c4dfc2d699f5d6dbc4d6daf7d1d3d699dfdfc499d0d8c1"><span class="__cf_email__" data-cfemail="f9b3968a918c98d7bb98958a9894b99f9d98d791918ad79e968f">[email protected]</span></a>.
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
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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
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Identified risks Mitigation measures
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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.
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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).
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
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