Medical Devices; General Hospital and Personal Use Devices; Classification of the Alternate Controller Enabled Infusion Pump, 6422-6425 [2022-02369]
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Federal Register / Vol. 87, No. 24 / Friday, February 4, 2022 / Rules and Regulations
(6) Software verification, validation,
and hazard analysis must be performed.
(7) Performance data must support
shelf life by demonstrating continued
sterility of the device or the sterile
components, package integrity, and
device functionality over the identified
shelf life.
(8) Human factors testing and analysis
must validate that the device design and
labeling are sufficient for the end user.
(9) Physician labeling must include:
(i) The operating parameters, name,
and model number of the indicated
external dosage controller;
(ii) Information on how the device
operates and the typical course of
treatment;
(iii) Information on the population for
which the device has been
demonstrated to be effective;
(iv) A detailed summary of the device
technical parameters; and
(v) Provisions for choosing an
appropriate size implant that would be
exchanged for the tissue expander.
(10) Patient labeling must include:
(i) Warnings, precautions, and
contraindications, and adverse events/
complications;
(ii) Information on how the device
operates and the typical course of
treatment;
(iii) The probable risks and benefits
associated with the use of the device;
(iv) Post-operative care instructions;
and
(v) Alternative treatments.
(11) Patient training must include
instructions for device use, when it may
be necessary to contact a physician, and
cautionary measures to take when the
device is implanted.
Dated: January 26, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–02357 Filed 2–3–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 880
lotter on DSK11XQN23PROD with RULES1
[Docket No. FDA–2021–N–0998]
Medical Devices; General Hospital and
Personal Use Devices; Classification
of the Alternate Controller Enabled
Infusion Pump
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final amendment; final order.
The Food and Drug
Administration (FDA, Agency, or we) is
SUMMARY:
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16:00 Feb 03, 2022
Jkt 256001
classifying the alternate controller
enabled infusion pump 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 alternate
controller enabled infusion pump’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:
Effective date: This order is effective
February 4, 2022.
Applicability date: The classification
was applicable on February 14, 2019.
FOR FURTHER INFORMATION CONTACT:
Ryan Lubert, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3574, Silver Spring,
MD 20993–0002, 240–402–6357,
Ryan.Lubert@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the
alternate controller enabled infusion
pump 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 (see 21
U.S.C. 360c(i)) to a predicate device that
does not require premarket approval.
We determine whether a new device is
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Sfmt 4700
substantially equivalent to a predicate
device 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. 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
section 513(f)(2)(B)(i) of the FD&C Act).
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 section 513(i) of the FD&C Act,
defining ‘‘substantial equivalence’’).
Instead, sponsors can use the lessburdensome 510(k) process, when
necessary, to market their device.
II. De Novo Classification
On October 29, 2018, FDA received
Tandem Diabetes Care, Inc.’s request for
De Novo classification of the t:slim X2
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insulin pump with interoperable
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 generals 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 February 14, 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 880.5730.1 We have named the
generic type of device ‘‘alternate
controller enabled infusion pump,’’ and
it is identified as an alternate controller
enabled infusion pump (ACE pump).
The ACE pump is a device intended for
6423
the infusion of drugs into a patient. The
ACE pump may include basal and bolus
drug delivery at set or variable rates.
ACE pumps are designed to reliably and
securely communicate with external
devices, such as automated drug dosing
systems, to allow drug delivery
commands to be received, executed, and
confirmed. ACE pumps are intended to
be used both alone and in conjunction
with digitally connected devices for the
purpose of drug delivery.
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—ALTERNATE CONTROLLER ENABLED INFUSION PUMP RISKS AND MITIGATION MEASURES
Identified risk
Mitigation measures
Patient harm due to inadequate drug delivery accuracy that leads to
over infusion or under infusion of drug.
Basal and bolus drug delivery accuracy validation testing, Device use
life reliability testing, Design mitigations to prevent cross-channeling.
Validated and traceable risk control measures for identified hazards.
Hazard detection (e.g., drug occlusion) validation testing.
Patient harm due to undetected pump occlusions that pose risk of
under infusion of drug.
Patient harm due to incompatibility between the drug and the pump
that may lead to over infusion or under infusion of drug, or exposure
to harmful substances leached from pump materials into the infused
drug solution.
Inability to provide appropriate treatment due to loss of communication
with digitally connected alternate pump controller devices.
Commands from the digitally connected alternate pump controller devices that conflict with existing pump commands may lead to unintended over or under infusion of drug.
Conflicting interfaces resulting in over or under delivery .........................
Patient harm due to insecure transmission of data .................................
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Patient harm due to inability to determine source of dosing error when
used in an integrated system.
Patient harm due to exposure to hazardous and non-biocompatible materials or pathogens.
Patient harm due to data transmission interference/electromagnetic disturbance.
Patient harm due to incorrect use of pump, operational, and/or use-related errors.
Drug compatibility testing.
Validated communication specifications, processes, and procedures
with digitally connected devices.
Validated communication specifications, processes, and procedures
with digitally connected devices, Validated failsafe design features.
Validated communication specifications, processes, and procedures
with digitally connected devices, Validated failsafe design features.
Validated communication specifications, processes, and procedures
with digitally connected devices.
Validated data logging capability.
Biocompatibility testing, Validation of reprocessing procedures.
Electrical safety, electromagnetic compatibility, and radio frequency
wireless safety testing.
Human Factors testing, Transparent pump performance descriptions in
labeling.
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. 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
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
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16:00 Feb 03, 2022
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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
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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
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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Federal Register / Vol. 87, No. 24 / Friday, February 4, 2022 / Rules and Regulations
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 the 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 880
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 880 is
amended as follows:
PART 880—GENERAL HOSPITAL AND
PERSONAL USE DEVICES
1. The authority citation for part 880
continues to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
2. Add § 880.5730 to subpart F to read
as follows:
■
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§ 880.5730 Alternate controller enabled
infusion pump.
(a) Identification. An alternate
controller enabled infusion pump (ACE
pump) is a device intended for the
infusion of drugs into a patient. The
ACE pump may include basal and bolus
drug delivery at set or variable rates.
ACE pumps are designed to reliably and
securely communicate with external
devices, such as automated drug dosing
systems, to allow drug delivery
commands to be received, executed, and
confirmed. ACE pumps are intended to
be used both alone and in conjunction
with digitally connected medical
devices for the purpose of drug delivery.
(b) Classification. Class II (special
controls). The special controls for this
device are:
(1) Design verification and validation
must include the following:
(i) Evidence demonstrating that
device infusion delivery accuracy
conforms to defined user needs and
intended uses and is validated to
support safe use under actual use
conditions.
(A) Design input requirements must
include delivery accuracy specifications
under reasonably foreseeable use
conditions, including ambient
temperature changes, pressure changes
(e.g., head-height, backpressure,
atmospheric), and, as appropriate,
different drug fluidic properties.
(B) Test results must demonstrate that
the device meets the design input
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requirements for delivery accuracy
under use conditions for the
programmable range of delivery rates
and volumes. Testing shall be
conducted with a statistically valid
number of devices to account for
variation between devices.
(ii) Validation testing results
demonstrating the ability of the pump to
detect relevant hazards associated with
drug delivery and the route of
administration (e.g., occlusions, air in
line, etc.) within a clinically relevant
timeframe across the range of
programmable drug delivery rates and
volumes. Hazard detection must be
appropriate for the intended use of the
device and testing must validate
appropriate performance under the
conditions of use for the device.
(iii) Validation testing results
demonstrating compatibility with drugs
that may be used with the pump based
on its labeling. Testing must include
assessment of drug stability under
reasonably foreseeable use conditions
that may affect drug stability (e.g.,
temperature, light exposure, or other
factors as needed).
(iv) The device parts that directly or
indirectly contact the patient must be
demonstrated to be biocompatible. This
shall include chemical and particulate
characterization on the final, finished,
fluid contacting device components
demonstrating that risk of harm from
device-related residues is reasonably
low.
(v) Evidence verifying and validating
that the device is reliable over the ACE
pump use life, as specified in the design
file, in terms of all device functions and
in terms of pump performance.
(vi) The device must be designed and
tested for electrical safety,
electromagnetic compatibility, and radio
frequency wireless safety and
availability consistent with patient
safety requirements in the intended use
environment.
(vii) For any device that is capable of
delivering more than one drug, the risk
of cross-channeling drugs must be
adequately mitigated.
(viii) For any devices intended for
multiple patient use, testing must
demonstrate validation of reprocessing
procedures and include verification that
the device meets all functional and
performance requirements after
reprocessing.
(2) Design verification and validation
activities 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 shall be
implemented to address device system
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hazards and the design decisions related
to how the risk control measures impact
essential performance shall be
documented.
(ii) 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 validated
interface specifications for digitally
connected devices. These interface
specifications shall, at a minimum,
provide for the following:
(i) Secure authentication (pairing) to
external devices.
(ii) Secure, accurate, and reliable
means of data transmission between the
pump and connected devices.
(iii) Sharing of necessary state
information between the pump and any
digitally connected alternate controllers
(e.g., battery level, reservoir level, pump
status, error conditions).
(iv) Ensuring that the pump continues
to operate safely when data is received
in a manner outside the bounds of the
parameters specified.
(v) A detailed process and procedure
for sharing the pump interface
specification with digitally connected
devices and for validating the correct
implementation of that protocol.
(4) The device must include
appropriate measures to ensure that safe
therapy is maintained when
communications with digitally
connected alternate controller devices is
interrupted, lost, or re-established after
an interruption (e.g., reverting to a preprogrammed, safe drug delivery rate).
Validation testing results must
demonstrate that critical events that
occur during a loss of communications
(e.g., commands, device malfunctions,
occlusions, etc.) are handled
appropriately during and after the
interruption.
(5) 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 system must,
at a minimum, include:
(i) A record of all drug delivery
(ii) Commands issued to the pump
and pump confirmations
(iii) Device malfunctions
(iv) Alarms and alerts and associated
acknowledgements
(v) Connectivity events (e.g.,
establishment or loss of
communications)
(6) Design verification and validation
must include results obtained through a
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Federal Register / Vol. 87, No. 24 / Friday, February 4, 2022 / Rules and Regulations
human factors study that demonstrates
that an intended user can safely use the
device for its intended use.
(7) Device labeling must include the
following:
(i) A prominent statement identifying
the drugs that are compatible with the
device, including the identity and
concentration of those drugs as
appropriate.
(ii) A description of the minimum and
maximum basal rates, minimum and
maximum bolus volumes, and the
increment size for basal and bolus
delivery, or other similarly applicable
information about drug delivery
parameters.
(iii) A description of the pump
accuracy at minimum, intermediate, and
maximum bolus delivery volumes and
the method(s) used to establish bolus
delivery accuracy. For each bolus
volume, pump accuracy shall be
described in terms of the number of
bolus doses measured to be within a
given range as compared to the
commanded volume. An acceptable
accuracy description (depending on the
drug delivered and bolus volume) may
be provided as follows for each bolus
volume tested, as applicable: Number of
bolus doses with volume that is <25
percent, 25 percent to <75 percent, 75
percent to <95 percent, 95 percent to
<105 percent, 105 percent to <125
percent, 125 percent to <175 percent,
175 to 250 percent, and >250 percent of
the commanded amount.
(iv) A description of the pump
accuracy at minimum, intermediate, and
maximum basal delivery rates and the
method(s) used to establish basal
delivery accuracy. For each basal rate,
pump accuracy shall be described in
terms of the amount of drug delivered
after the basal delivery was first
commanded, without a warmup period,
up to various time points. The
information provided must include
typical pump performance, as well as
worst-case pump performance observed
during testing in terms of both overdelivery and under-delivery. An
acceptable accuracy description
(depending on the drug delivered) may
be provided as follows, as applicable:
The total volume delivered 1 hour, 6
hours, and 12 hours after starting
delivery for a typical pump tested, as
well as for the pump that delivered the
least and the pump that delivered the
most at each time point.
(v) A description of delivery hazard
alarm performance, as applicable. For
occlusion alarms, performance shall be
reported at minimum, intermediate, and
maximum delivery rates and volumes.
This description must include the
specification for the longest time period
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that may elapse before an occlusion
alarm is triggered under each delivery
condition, as well as the typical results
observed during performance testing of
the pumps.
(vi) For wireless connection enabled
devices, a description of the wireless
quality of service required for proper
use of the device.
(vii) For any infusion pumps intended
for multiple patient reuse, instructions
for safely reprocessing the device
between uses.
Dated: January 26, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–02369 Filed 2–3–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF VETERANS
AFFAIRS
38 CFR Part 17
RIN 2900–AQ97
Informed Consent and Advance
Directives
Department of Veterans Affairs.
Interim final rule.
AGENCY:
ACTION:
The Department of Veterans
Affairs (VA) published an interim final
rule amending its regulation regarding
informed consent and advance
directives. In that rulemaking, we
amended the regulation by reorganizing
it and amending language where
necessary to enhance clarity. We also
made changes to facilitate the informed
consent process, the ability to
communicate with patients or
surrogates through available modalities
of communication, and the execution
and witness requirements for a VA
Advance Directive. Before adopting that
interim final rule as final, VA revises
the provision related to which
personnel may be delegated the
responsibility for providing a patient
with information needed for the patient
to make a fully informed consent
decision. Upon further review, VA has
determined that this provision requires
a further change to better clarify roles in
the team-based delivery of care model.
We are providing the public an
opportunity to submit comments solely
on this amendment.
DATES:
Effective date: This interim final rule
is effective February 4, 2022.
Comments due date: Comments must
be received on or before April 5, 2022.
ADDRESSES: Comments may be
submitted through
www.Regulations.gov. Comments
SUMMARY:
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6425
received will be available at
regulations.gov for public viewing,
inspection, or copies.
FOR FURTHER INFORMATION CONTACT:
Lucinda Potter, LSW, Acting Director of
Ethics Policy, National Center for Ethics
in Health Care (10ETH), Veterans Health
Administration, 810 Vermont Ave. NW,
Washington, DC 20420; 484–678–5150.
(This is not a toll-free number).
SUPPLEMENTARY INFORMATION: In an
interim final rule published May 27,
2020 (85 FR 31690), we amended 38
CFR 17.32, our regulation addressing
informed consent for treatments and
procedures, by reorganizing it and
amending language where necessary to
enhance clarity. We also made changes
to facilitate the informed consent
process, the ability to communicate
with patients or surrogates through
available modalities of communication,
and the execution and witnessing for a
VA Advance Directive. We amended the
definition of ‘‘practitioner’’ to include
other health care professionals whose
scope of practice agreement or other
formal delineation of job responsibility
specifically permits them to obtain
informed consent, and who are
appropriately trained and authorized to
perform the procedure or to provide the
treatment for which consent is being
obtained.
Under the previous informed consent
rule, the practitioner, who had primary
responsibility for the patient or who
would perform the particular procedure
or provide the treatment, was
responsible for explaining in language
understandable to the patient or
surrogate the nature of a proposed
procedure or treatment; the expected
benefits; reasonably foreseeable
associated risks, complications or side
effects; reasonable and available
alternatives; and anticipated results if
nothing is done. There was no provision
in the rule addressing the question of
whether, consistent with a team-based
delivery of care model, appropriately
trained health care team members had a
role in the informed consent process. In
the May 2020 interim final rule, we
dealt with that issue in paragraph (c)(6),
stating that the practitioner may
delegate to other trained personnel
responsibility for providing the patient
with clinical information needed for the
patient to make a fully informed consent
decision but must personally verify with
the patient that the patient has been
appropriately informed and voluntarily
consents to the treatment or procedure.
VA intended that paragraph (c)(6) give
the practitioner discretion to more fully
utilize the training and expertise of nonpractitioners within the bounds of the
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]]>Agencies
[Federal Register Volume 87, Number 24 (Friday, February 4, 2022)]
[Rules and Regulations]
[Pages 6422-6425]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-02369]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 880
[Docket No. FDA-2021-N-0998]
Medical Devices; General Hospital and Personal Use Devices;
Classification of the Alternate Controller Enabled Infusion Pump
AGENCY: Food and Drug Administration, HHS.
ACTION: Final amendment; final order.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
classifying the alternate controller enabled infusion pump 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 alternate controller enabled infusion pump'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:
Effective date: This order is effective February 4, 2022.
Applicability date: The classification was applicable on February
14, 2019.
FOR FURTHER INFORMATION CONTACT: Ryan Lubert, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3574, Silver Spring, MD 20993-0002, 240-402-6357,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the alternate controller enabled
infusion pump 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 (see 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 device 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. 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
section 513(f)(2)(B)(i) of the FD&C Act). 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 section
513(i) of the FD&C Act, defining ``substantial equivalence''). Instead,
sponsors can use the less-burdensome 510(k) process, when necessary, to
market their device.
II. De Novo Classification
On October 29, 2018, FDA received Tandem Diabetes Care, Inc.'s
request for De Novo classification of the t:slim X2
[[Page 6423]]
insulin pump with interoperable 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 generals 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 February 14, 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
880.5730.\1\ We have named the generic type of device ``alternate
controller enabled infusion pump,'' and it is identified as an
alternate controller enabled infusion pump (ACE pump). The ACE pump is
a device intended for the infusion of drugs into a patient. The ACE
pump may include basal and bolus drug delivery at set or variable
rates. ACE pumps are designed to reliably and securely communicate with
external devices, such as automated drug dosing systems, to allow drug
delivery commands to be received, executed, and confirmed. ACE pumps
are intended to be used both alone and in conjunction with digitally
connected devices for the purpose of drug delivery.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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--Alternate Controller Enabled Infusion Pump Risks and Mitigation
Measures
------------------------------------------------------------------------
Identified risk Mitigation measures
------------------------------------------------------------------------
Patient harm due to inadequate drug Basal and bolus drug delivery
delivery accuracy that leads to over accuracy validation testing,
infusion or under infusion of drug. Device use life reliability
testing, Design mitigations to
prevent cross-channeling.
Validated and traceable risk
control measures for
identified hazards.
Patient harm due to undetected pump Hazard detection (e.g., drug
occlusions that pose risk of under occlusion) validation testing.
infusion of drug.
Patient harm due to incompatibility Drug compatibility testing.
between the drug and the pump that may
lead to over infusion or under
infusion of drug, or exposure to
harmful substances leached from pump
materials into the infused drug
solution.
Inability to provide appropriate Validated communication
treatment due to loss of communication specifications, processes, and
with digitally connected alternate procedures with digitally
pump controller devices. connected devices.
Commands from the digitally connected Validated communication
alternate pump controller devices that specifications, processes, and
conflict with existing pump commands procedures with digitally
may lead to unintended over or under connected devices, Validated
infusion of drug. failsafe design features.
Conflicting interfaces resulting in Validated communication
over or under delivery. specifications, processes, and
procedures with digitally
connected devices, Validated
failsafe design features.
Patient harm due to insecure Validated communication
transmission of data. specifications, processes, and
procedures with digitally
connected devices.
Patient harm due to inability to Validated data logging
determine source of dosing error when capability.
used in an integrated system.
Patient harm due to exposure to Biocompatibility testing,
hazardous and non-biocompatible Validation of reprocessing
materials or pathogens. procedures.
Patient harm due to data transmission Electrical safety,
interference/electromagnetic electromagnetic compatibility,
disturbance. and radio frequency wireless
safety testing.
Patient harm due to incorrect use of Human Factors testing,
pump, operational, and/or use-related Transparent pump performance
errors. descriptions in labeling.
------------------------------------------------------------------------
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. 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
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
[[Page 6424]]
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 the 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 880
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
880 is amended as follows:
PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES
0
1. The authority citation for part 880 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 880.5730 to subpart F to read as follows:
Sec. 880.5730 Alternate controller enabled infusion pump.
(a) Identification. An alternate controller enabled infusion pump
(ACE pump) is a device intended for the infusion of drugs into a
patient. The ACE pump may include basal and bolus drug delivery at set
or variable rates. ACE pumps are designed to reliably and securely
communicate with external devices, such as automated drug dosing
systems, to allow drug delivery commands to be received, executed, and
confirmed. ACE pumps are intended to be used both alone and in
conjunction with digitally connected medical devices for the purpose of
drug delivery.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Design verification and validation must include the following:
(i) Evidence demonstrating that device infusion delivery accuracy
conforms to defined user needs and intended uses and is validated to
support safe use under actual use conditions.
(A) Design input requirements must include delivery accuracy
specifications under reasonably foreseeable use conditions, including
ambient temperature changes, pressure changes (e.g., head-height,
backpressure, atmospheric), and, as appropriate, different drug fluidic
properties.
(B) Test results must demonstrate that the device meets the design
input requirements for delivery accuracy under use conditions for the
programmable range of delivery rates and volumes. Testing shall be
conducted with a statistically valid number of devices to account for
variation between devices.
(ii) Validation testing results demonstrating the ability of the
pump to detect relevant hazards associated with drug delivery and the
route of administration (e.g., occlusions, air in line, etc.) within a
clinically relevant timeframe across the range of programmable drug
delivery rates and volumes. Hazard detection must be appropriate for
the intended use of the device and testing must validate appropriate
performance under the conditions of use for the device.
(iii) Validation testing results demonstrating compatibility with
drugs that may be used with the pump based on its labeling. Testing
must include assessment of drug stability under reasonably foreseeable
use conditions that may affect drug stability (e.g., temperature, light
exposure, or other factors as needed).
(iv) The device parts that directly or indirectly contact the
patient must be demonstrated to be biocompatible. This shall include
chemical and particulate characterization on the final, finished, fluid
contacting device components demonstrating that risk of harm from
device-related residues is reasonably low.
(v) Evidence verifying and validating that the device is reliable
over the ACE pump use life, as specified in the design file, in terms
of all device functions and in terms of pump performance.
(vi) The device must be designed and tested for electrical safety,
electromagnetic compatibility, and radio frequency wireless safety and
availability consistent with patient safety requirements in the
intended use environment.
(vii) For any device that is capable of delivering more than one
drug, the risk of cross-channeling drugs must be adequately mitigated.
(viii) For any devices intended for multiple patient use, testing
must demonstrate validation of reprocessing procedures and include
verification that the device meets all functional and performance
requirements after reprocessing.
(2) Design verification and validation activities 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 shall be implemented to address device
system hazards and the design decisions related to how the risk control
measures impact essential performance shall be documented.
(ii) 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 validated interface specifications for
digitally connected devices. These interface specifications shall, at a
minimum, provide for the following:
(i) Secure authentication (pairing) to external devices.
(ii) Secure, accurate, and reliable means of data transmission
between the pump and connected devices.
(iii) Sharing of necessary state information between the pump and
any digitally connected alternate controllers (e.g., battery level,
reservoir level, pump status, error conditions).
(iv) Ensuring that the pump continues to operate safely when data
is received in a manner outside the bounds of the parameters specified.
(v) A detailed process and procedure for sharing the pump interface
specification with digitally connected devices and for validating the
correct implementation of that protocol.
(4) The device must include appropriate measures to ensure that
safe therapy is maintained when communications with digitally connected
alternate controller devices is interrupted, lost, or re-established
after an interruption (e.g., reverting to a pre-programmed, safe drug
delivery rate). Validation testing results must demonstrate that
critical events that occur during a loss of communications (e.g.,
commands, device malfunctions, occlusions, etc.) are handled
appropriately during and after the interruption.
(5) 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 system
must, at a minimum, include:
(i) A record of all drug delivery
(ii) Commands issued to the pump and pump confirmations
(iii) Device malfunctions
(iv) Alarms and alerts and associated acknowledgements
(v) Connectivity events (e.g., establishment or loss of
communications)
(6) Design verification and validation must include results
obtained through a
[[Page 6425]]
human factors study that demonstrates that an intended user can safely
use the device for its intended use.
(7) Device labeling must include the following:
(i) A prominent statement identifying the drugs that are compatible
with the device, including the identity and concentration of those
drugs as appropriate.
(ii) A description of the minimum and maximum basal rates, minimum
and maximum bolus volumes, and the increment size for basal and bolus
delivery, or other similarly applicable information about drug delivery
parameters.
(iii) A description of the pump accuracy at minimum, intermediate,
and maximum bolus delivery volumes and the method(s) used to establish
bolus delivery accuracy. For each bolus volume, pump accuracy shall be
described in terms of the number of bolus doses measured to be within a
given range as compared to the commanded volume. An acceptable accuracy
description (depending on the drug delivered and bolus volume) may be
provided as follows for each bolus volume tested, as applicable: Number
of bolus doses with volume that is <25 percent, 25 percent to <75
percent, 75 percent to <95 percent, 95 percent to <105 percent, 105
percent to <125 percent, 125 percent to <175 percent, 175 to 250
percent, and >250 percent of the commanded amount.
(iv) A description of the pump accuracy at minimum, intermediate,
and maximum basal delivery rates and the method(s) used to establish
basal delivery accuracy. For each basal rate, pump accuracy shall be
described in terms of the amount of drug delivered after the basal
delivery was first commanded, without a warmup period, up to various
time points. The information provided must include typical pump
performance, as well as worst-case pump performance observed during
testing in terms of both over-delivery and under-delivery. An
acceptable accuracy description (depending on the drug delivered) may
be provided as follows, as applicable: The total volume delivered 1
hour, 6 hours, and 12 hours after starting delivery for a typical pump
tested, as well as for the pump that delivered the least and the pump
that delivered the most at each time point.
(v) A description of delivery hazard alarm performance, as
applicable. For occlusion alarms, performance shall be reported at
minimum, intermediate, and maximum delivery rates and volumes. This
description must include the specification for the longest time period
that may elapse before an occlusion alarm is triggered under each
delivery condition, as well as the typical results observed during
performance testing of the pumps.
(vi) For wireless connection enabled devices, a description of the
wireless quality of service required for proper use of the device.
(vii) For any infusion pumps intended for multiple patient reuse,
instructions for safely reprocessing the device between uses.
Dated: January 26, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-02369 Filed 2-3-22; 8:45 am]
BILLING CODE 4164-01-P
