[Federal Register Volume 80, Number 221 (Tuesday, November 17, 2015)]
[Notices]
[Pages 71868-71870]
[FR Doc No: 2015-29228]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-76422; File No. SR-NYSE-2015-45]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Constituting a Stated Interpretation With Respect to the Meaning,
Administration, and Enforcement of Rule 28

November 10, 2015.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that October 28,

2015, New York Stock Exchange LLC (``NYSE'' or the ``Exchange'') filed
with the Securities and Exchange Commission (the ``Commission'') the
proposed rule change as described in Items I and II below, which Items
have been prepared by the self-regulatory organization. The Commission
is publishing this notice to solicit comments on the proposed rule
change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to constitute a stated interpretation with
respect to the meaning, administration, and enforcement of Rule 28. The
proposed rule change is available on the Exchange's Web site at
www.nyse.com, at the principal office of the Exchange, and at the
Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes a rule change that constitutes a stated
interpretation with respect to the meaning, administration, and
enforcement of Rule 28 (``Rule 28''). The Exchange is not proposing any
changes to the text of the current version of Rule 28.
    Approved in 2003,\4\ Rule 28 describes and provides the basis for
the Exchange's practice of conducting fingerprint-based criminal record
checks. The Rule permits the Exchange to obtain fingerprints of
prospective and current employees, temporary personnel, independent
contractors and service providers of the Exchange and its principal
subsidiaries; submit those fingerprints to the Attorney General of the
United States or his or her designee (``Attorney General'') for
identification and processing; and receive criminal history record
information from the Attorney General for evaluation and use, in
accordance with applicable law, in enhancing the security of the
facilities, systems, data, and/or records of the Exchange and its
principal subsidiaries.
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    \4\ See Securities Exchange Act Release No. 4811 (July 1, 2003),
68 FR 41033 (July 9, 2003) (SR-NYSE-2003-18).
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    The Exchange utilizes a Live-Scan \5\ electronic system to capture
and transmit fingerprints directly to the Federal Bureau of
Investigation (``FBI''), which maintains on behalf of the Attorney
General a database of fingerprint-based criminal history records. The
capture and transmittal function, and corresponding receipt of criminal
history information from the FBI, is handled directly by Exchange
personnel. The Exchange intends to engage an FBI-approved ``Channel
Partner'' \6\ to maintain and operate, on behalf of the Exchange, a
Live-Scan and/or other electronic system(s) for the submission of
fingerprints to the FBI; to receive and maintain criminal history
record information from the FBI; and to disseminate such information,
through secure systems, to a limited set of approved reviewing
officials within the Exchange and its affiliates. The Exchange believes
Rule 28 allows for the retention of a Channel Partner for these
purposes.\7\
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    \5\ Live-Scan refers to the process of capturing fingerprints
directly into a digitized format as opposed to traditional ink and
paper methods. Live-Scan technology captures and transfers images to
a central location and/or interface for identification processing.
The Exchange has used Live-Scan technology for fingerprinting since
Rule 28 was approved in 2003.
    \6\ FBI-approved Channel Partners receive the fingerprint
submission and relevant data, collect the associated fee(s),
electronically forward the fingerprint submission with the necessary
information to the FBI Criminal Justice Information Services
Division (``CJIS'') for a national Criminal History Summary check,
and receive the electronic summary check result for dissemination to
the authorized employer entity. See Securities Exchange Act Release
No. 71066 (December 12, 2013), 78 FR 76667 (December 18, 2013) (SR-
ISE-2013-66).
    \7\ Rule 28 allows the Exchange to obtain fingerprints from
service providers, including employees of affiliates of the
Exchange. See Chicago Board Options Exchange, Incorporated
(``CBOE'') Rule 15.10; Securities Exchange Act Release No. 69496
(May 2, 2013), 78 FR 26671, 26671 (May 7, 2013) (SR-CBOE-2013-044)
(CBOE conducts fingerprint-based criminal record checks of
directors, officers and employees as well as, without limitation,
``temporary personnel, independent contractors, consultants, vendors
and service providers . . . who have or are anticipated to have
access to facilities and records.'').
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    The foregoing interpretation is consistent with the Exchange's
authority under Section 17(f)(2) of the Act, as amended by the Dodd-
Frank Wall Street Reform and Consumer Protection Act of 2010 (``Dodd-
Frank Act''),\8\ which requires, inter alia, that employees of
exchanges be fingerprinted and that exchanges ``shall submit such
fingerprints, or cause the same to be submitted, to the Attorney
General of the United States for identification and appropriate
processing.'' The Exchange further notes that the proposed
interpretation is consistent with the rules and procedures at other
self-regulatory organizations (``SROs'').\9\
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    \8\ See 15 U.S.C. 17(f)(2) [sic]; Dodd-Frank Act Sect. 929S.
    \9\ See International Securities Exchange (``ISE'') Rule 1408;
Chicago Board Options Exchange (``CBOE'') Rule 15.10. See generally
Securities Exchange Act Release No. 71066 (December 12, 2013), 78 FR
76667, 76668 n. 12 (December 18, 2013) (SR-ISE-2013-66) (noting that
``[a]n FBI-approved Channel Partner simply helps expedite the
delivery of Criminal History Summary information on behalf of the
FBI'', and that the ``process for making a request through an FBI-
approved Channel Partner is consistent with FBI submission
procedures'').
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    The Exchange accordingly believes that under Rule 28 and applicable
statutes, the Exchange has the authority to engage an FBI-approved
Channel Partner for some or all of the fingerprinting processes
described in the Rule. The Exchange believes that this proposed
interpretation would ensure the Exchange's continued compliance with
its Rules and applicable state and federal law.\10\
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    \10\ Access to the FBI's fingerprint-based database of criminal
records is permitted only when authorized by law. Section 17(f)(2)
of the Act explicitly directs the Attorney General to provide SROs
designated by the Commission (e.g., the Exchange) with access to
such criminal history record information. Further, as amended by the
Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010,
Section 17(f)(2) specifically requires, inter alia, that employees
of national securities exchanges be fingerprinted. New York's
General Business Law also requires SROs to fingerprint employees
``as a condition of employment,'' as well as certain non-employee
service providers. N.Y. Gen. Bus. Law Sec.  359-e (McKinney).
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2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\11\ in general, and furthers the
objectives of Section 6(b)(5) of the Act,\12\ in particular, because it
is designed to prevent fraudulent and manipulative acts and practices,
promote just and equitable principles of trade, remove impediments to
and perfect the mechanism of a free and open market and a national
market system, and protect investors and the public interest. The
Exchange believes that the proposed stated interpretation would enable
the Exchange to continue to identify and exclude persons with felony or
misdemeanor conviction

records that may pose a threat to the safety of Exchange personnel or
the security of facilities and records, thereby enhancing business
continuity, workplace safety and the security of the Exchange's
operations and helping to protect investors and the public interest.
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    \11\ 15 U.S.C. 78f(b).
    \12\ 15 U.S.C. 78f(b)(5).
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    Continuing to run fingerprint-based background checks is imperative
for the Exchange and its affiliates, as this process helps to identify
persons with criminal history records who may pose a threat to the
safety of Exchange personnel and/or the security of Exchange facilities
and records. This identification and screening process thus enhances
business continuity, workplace safety, and the security of the
Exchange's operations. The use of an FBI-approved Channel Partner in
some or all phases of this process is consistent with Rule 28 and
applicable state and federal law, and in furtherance of the important
objectives described herein. Additionally, the use of a Channel Partner
is consistent with the fingerprinting method currently employed by
other SROs.\13\ For all these reasons, the proposal is also designed to
protect investors as well as the public interest.
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    \13\ See note 9, supra.
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change would
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The proposed rule change
would enhance the security of the Exchange's facilities and records
without adding any burden on market participants and allow the Exchange
continued compliance with its fingerprinting rules and with Section
17(f)(2) of the Act as amended by the Dodd-Frank Act.\14\
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    \14\ See Section 929S of the Dodd-Frank Act.
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C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were solicited or received with respect to the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \15\ and Rule 19b-4(f)(1) \16\ thereunder. The
proposed rule change effects a change that constitutes a stated policy,
practice or interpretation with respect to the meaning, administration,
or enforcement of an existing rule.
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    \15\ 15 U.S.C. 78s(b)(3)(A).
    \16\ 17 CFR 240.19b-4(f)(6).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission will institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSE-2015-45 on the subject line.

Paper Comments

     Send paper comments in triplicate to Brent J. Fields,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-NYSE-2015-45. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between 10 a.m. and 3
p.m. Copies of the filing will also be available for inspection and
copying at the NYSE's principal office and on its Internet Web site at
www.nyse.com. All comments received will be posted without change; the
Commission does not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-
NYSE-2015-45 and should be submitted on or before December 8, 2015.
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    \17\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-29228 Filed 11-16-15; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 49 (Monday, March 14, 2022)]
[Rules and Regulations]
[Pages 14171-14174]
[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,<PHONE_NUMBER>,
[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

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
------------------------------------------------------------------------
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

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.

    (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