Medical Devices; Exemption From Premarket Notification: Powered Patient Transport, All Other Powered Patient Transport, 69583-69586 [2021-26636]
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Federal Register / Vol. 86, No. 233 / Wednesday, December 8, 2021 / Rules and Regulations
reorganization of its fuel-related
regulations.
These rule revisions are effective
on December 8, 2021.
FOR FURTHER INFORMATION CONTACT:
Hampton Newsome (202–326–2889),
Attorney, Division of Enforcement,
Bureau of Consumer Protection, Federal
Trade Commission, Room CC–9528, 600
Pennsylvania Avenue NW, Washington,
DC 20580.
SUPPLEMENTARY INFORMATION:
DATES:
I. Conforming Amendment
Recently, EPA issued amendments
streamlining its fuel quality regulations
(85 FR 78412 (Dec. 4, 2020)). As part of
this process, EPA transferred regulations
that are cross-referenced in the FTC’s
Fuel Rating Rule from 40 CFR part 80
to a new 40 CFR part 1090. To conform
to these changes, the FTC amends
§ 306.10 of its Fuel Rating Rule to
update a reference to EPA’s ethanol
labeling requirements in paragraph (a).
Specifically, in 16 CFR 306.10(a), the
amendment removes the reference to 40
CFR 80.1501 and adds, in its place, a
reference to 40 CFR 1090.1510 (the new
location of those same EPA
requirements).
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II. Procedural Requirements
There is good cause for adopting this
final rule without advance public notice
or an opportunity for public comment.1
The amendment published in this
document merely updates a cross
reference to an EPA fuel quality rule
referenced in the Commission’s Rule.
This minor technical revision does not
change any substantive obligations
under the Rule or create new
requirements. In addition, under the
Administrative Procedure Act, a final
rule may be made effective without 30
days advance publication in the Federal
Register if an agency finds good cause.
Prompt adoption of this amendment is
necessary to avoid confusion by
updating the Rule’s reference to EPA’s
ethanol labeling requirement. Therefore,
this final rule is effective upon
publication in the Federal Register.
The Office of Management and Budget
(‘‘OMB’’) has approved the information
collections contained in the Rule
through September 30, 2023 (OMB
Control No. 3084–0068). Since this
amendment only updates a crossreference to existing EPA requirements,
1 Notice and comment are not required ‘‘when the
agency for good cause finds (and incorporates the
finding and a brief statement of reasons therefore
in the rules issued) that notice and public
procedure thereon are impracticable, unnecessary,
or contrary to the public interest.’’ 5 U.S.C.
553(b)(3)(B).
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it does not change the Rule’s
information collection requirements and
does not require further OMB clearance.
The requirements of the Regulatory
Flexibility Act also do not apply.2
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), the Office of
Information and Regulatory Affairs
designated this rule as not a ‘‘major
rule,’’ as defined by 5 U.S.C. 804(2).
List of Subjects in 16 CFR Part 306
Fuel, Fuel ratings, Gasoline, Trade
practices.
For the reasons discussed in the
preamble, the Federal Trade
Commission amends part 306 of Title 16
of the Code of Federal Regulations as
follows:
PART 306—AUTOMOTIVE FUEL
RATINGS, CERTIFICATION AND
POSTING
1. The authority citation for part 306
continues to read as follows:
■
Authority: 15 U.S.C. 2801 et seq.; 42 U.S.C.
17021.
§ 306.10
[Amended]
2. In § 306.10, in paragraph (a),
remove ‘‘40 CFR 80.1501’’ and add in its
place ‘‘40 CFR 1090.1510’’.
■
April J. Tabor,
Secretary.
[FR Doc. 2021–26558 Filed 12–7–21; 8:45 am]
BILLING CODE 6750–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 890
[Docket No. FDA–2021–P–0424]
Medical Devices; Exemption From
Premarket Notification: Powered
Patient Transport, All Other Powered
Patient Transport
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final amendment; final order.
The Food and Drug
Administration (FDA or Agency) is
publishing an order setting forth the
final determination of a petition
requesting exemption from premarket
notification (510(k)) requirements for
the generic device type, powered patient
transport, all other powered patient
SUMMARY:
2 A regulatory flexibility analysis under the RFA
is required only when an agency must publish a
notice of proposed rulemaking for comment. See 5
U.S.C. 603.
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transport (product code ILK), classified
as class II devices. These devices are
motorized devices used to mitigate
mobility impairment caused by injury or
other disease by moving a person from
one location or level to another, such as
up and down flights of stairs. These
devices do not include motorized threewheeled vehicles or wheelchairs, and
are distinct from the device type,
powered patient transport, powered
patient stairway chair lifts, which is
classified separately within the same
regulation (product code PCD). FDA is
publishing this order in accordance
with procedures established in the
Federal Food, Drug, and Cosmetic Act
(FD&C Act).
DATES: This order is effective December
8, 2021.
FOR FURTHER INFORMATION CONTACT: Dan
Reed, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm.1526, Silver Spring,
MD 20993–0002, 240–402–4717.
SUPPLEMENTARY INFORMATION:
I. Statutory Background
Section 510(k) of the FD&C Act (21
U.S.C. 360(k)) and its implementing
regulations in part 807, subpart E (21
CFR part 807, subpart E) require persons
who propose to begin the introduction
or delivery for introduction into
interstate commerce for commercial
distribution of a device intended for
human use to submit a 510(k) to FDA.
The device may not be marketed until
FDA finds it ‘‘substantially equivalent’’
within the meaning of section 513(i) of
the FD&C Act (21 U.S.C. 360c(i)) to a
legally marketed device that does not
require premarket approval.
On November 21, 1997, the President
signed into law the Food and Drug
Administration Modernization Act of
1997 (FDAMA) (Pub. L. 105–115),
section 206 of which added section
510(m) to the FD&C Act, which was
amended on December 13, 2016, by the
21st Century Cures Act (Cures Act)
(Pub. L. 114–255). Section 510(m)(1) of
the FD&C Act, requires FDA to publish
in the Federal Register a list of each
type of class II device that does not
require a report under section 510(k) of
the FD&C Act to provide reasonable
assurance of safety and effectiveness.
Section 510(m) of the FD&C Act further
provides that a 510(k) will no longer be
required for these devices upon the date
of publication of the list in the Federal
Register. FDA published the required
lists in accordance with FDAMA and
the Cures Act, in the Federal Register of
January 21, 1998 (63 FR 3142), and July
11, 2017 (82 FR 31976), respectively.
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Section 510(m)(2) of the FD&C Act
provides that FDA may exempt a device
from 510(k) requirements on its own
initiative, or upon petition of an
interested person, if FDA determines
that a 510(k) is not necessary to provide
assurance of the safety and effectiveness
of the device. This section requires FDA
to publish in the Federal Register a
notice of intent to exempt a device, or
of the petition, and to provide a 60-day
period for public comment. Within 120
days after the issuance of the notice,
FDA shall publish an order in the
Federal Register setting forth the final
determination regarding the exemption
of the device that was the subject of the
notice. If FDA fails to respond to a
petition under this section within 180
days of receiving it, the petition shall be
deemed granted.
FDA classified powered patient
transport devices into class II effective
December 23, 1983 (48 FR 53032,
November 23, 1983). All powered
patient transport devices were class II
devices regulated under § 890.5150 (21
CFR 890.5150), product code ILK. In
2013, FDA amended § 890.5150 in
response to a citizen petition requesting
the Agency exempt permanently
mounted stairway chair lifts from
premarket notification requirements (78
FR 14015, March 4, 2013). In granting
this request, FDA defined a subset of
powered patient transport devices
classified under new § 890.5150(a),
identified as ‘‘powered patient stairway
chair lifts,’’ product code PCD, and
exempted this subset of devices from
510(k) premarket notification
requirements provided certain
conditions are met. The exemption did
not affect ‘‘all other powered patient
transport devices’’ identified under new
§ 890.5150(b), product code ILK. Under
§ 890.5150(b), a powered patient
transport is a motorized device intended
for use in mitigating mobility
impairment caused by injury or other
disease by moving a person from one
location or level to another, such as up
and down flights of stairs (e.g.,
attendant-operated portable stairclimbing chairs). This generic type of
device does not include motorized
three-wheeled vehicles or wheelchairs.
II. Criteria for Exemption
There are a number of factors FDA
may consider in order to determine
whether a 510(k) is necessary to provide
reasonable assurance of the safety and
effectiveness of a class II device. FDA
generally considers the following factors
to determine whether premarket
notification is necessary: (1) The device
does not have a significant history of
false or misleading claims or risks
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associated with inherent characteristics
of the device (when making these
determinations, FDA has considered the
risks associated with false or misleading
claims, and the frequency, persistence,
cause or seriousness of the inherent
risks of the device); (2) characteristics of
the device necessary for its safe and
effective performance are well
established; (3) changes in the device
that could affect safety and effectiveness
will either (a) be readily detectable by
users by visual examination or other
means such as routine testing, before
causing harm, or (b) not materially
increase the risk of injury, incorrect
diagnosis, or ineffective treatment; and
(4) any changes to the device would not
be likely to result in a change in the
device’s classification. FDA may also
consider that, even when exempting
devices, these devices would still be
subject to the limitations on
exemptions.
These factors are discussed in the
guidance that the Agency issued on
February 19, 1998, entitled ‘‘Procedures
for Class II Device Exemptions from
Premarket Notification, Guidance for
Industry and CDRH Staff’’ (Class II
510(k) Exemption Guidance). That
guidance can be obtained through the
internet at https://www.fda.gov/
downloads/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/UCM080199.pdf
or by sending an email request to CDRHGuidance@fda.hhs.gov to receive a copy
of the document. Please use the
document number 159 to identify the
guidance you are requesting.
III. Petition
On April 30, 2021, FDA received a
petition requesting an exemption from
premarket notification for powered
patient transport, all other powered
patient transport (see Docket No. FDA–
2021–P–0424). These devices are
currently classified under § 890.5150(b),
powered patient transport, all other
powered patient transport. The
classification regulation is split into
paragraphs (a) and (b) with stairway
chair lifts classified under § 890.5150(a)
(product code PCD), exempt from
premarket notification requirements
provided certain conditions are met,
while all other powered patient
transport devices are classified in
§ 890.5150(b) (product code ILK) and
remain subject to premarket notification
requirements. Importantly, many
different devices are classified under the
generic device-type within
§ 890.5150(b). The FDA review focused
on ‘‘all other powered patient transport’’
devices identified under § 890.5150(b),
and specifically, powered portable stair-
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climbing chairs as described in the
petition (see Docket No. FDA–2021–P–
0424).
In the Federal Register of June 15,
2021 (86 FR 31722), FDA published a
notice announcing that this petition had
been received and provided opportunity
for interested persons to submit
comments on the petition by August 16,
2021. In the Federal Register of June 30,
2021 (86 FR 34770), FDA published a
correction to the docket number, and, in
the Federal Register of July 23, 2021 (86
FR 39047), subsequently extended the
opportunity to submit comments on the
petition to August 30, 2021. FDA
received one comment that is unrelated
to the petition and, thus, outside the
scope of this final order.
FDA completed review of the petition
and assessed the need for 510(k)
clearance for this type of device against
the criteria laid out in the Class II 510(k)
Exemption Guidance. Based on this
review, and for the reasons described in
section IV, FDA has determined that
premarket notification is necessary to
provide a reasonable assurance of the
safety and effectiveness of powered
patient transport, all other powered
patient transport, § 890.5150(b)(2)
(product code ILK). Accordingly, FDA
responded to the petition by letter dated
October 19, 2021, denying the petition
within the 180-day timeframe under
section 510(m)(2) of the FD&C Act (see
Docket No. FDA–2021–P–0424).
IV. Order
After reviewing the petition, FDA has
determined that the petition failed to
provide information to demonstrate that
premarket notification is not necessary
to provide reasonable assurance of the
safety and effectiveness of the device.
FDA analyzed the petition against the
criteria laid out in the Class II 510(k)
Exemption Guidance.
A. The Device Does Not Have a
Significant History of False or
Misleading Claims or Risks Associated
With Inherent Characteristics of the
Device
The petition included a 5-year look at
FDA medical device reports (MDRs), the
FDA medical device recall database, and
the FDA warning letter database using
§ 890.5150, product code ILK and other
product codes for other device
classifications, which are listed as
comparable device classifications to
powered patient transport, all other
powered patient transport. While FDA
does not have a concern related to the
absence of warning letters or recalls nor,
more generally, to a significant history
of false or misleading claims, we do not
agree that the use of the device is well
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established without any reports of
patient or user injury or that the device
does not have a significant history of
risks associated with inherent
characteristics of the device solely based
on a non-substantial number of MDR
reports of patient or user injury.
Although there have been no MDRs
submitted to the Agency in the past 5
years for powered portable stairclimbing chairs under product code ILK,
since September 15, 1998, FDA has
received four MDRs related to powered
patient transport devices including two
involving serious injury to the patient,
one of which involved both patient and
operator injury.
The petition includes a comparison to
other devices, but because these other
devices and powered portable stairclimbing chairs differ in technological
characteristics and safety profiles, a
comparison of the number of MDRs
does not provide relevant information
regarding the history of risks associated
with the inherent characteristics of
powered patient transports under
§ 890.5150(b), or powered portable stairclimbing chairs more specifically.
The petition also does not consider
risks associated with powered
wheelchairs, which must also be
analyzed given that the FDA-cleared
powered portable stair-climbing chairs
adhere to wheelchair consensus
standards, and the unique stair-climbing
functionality of the powered portable
stair-climbing chair can entail a higher
degree of risk related to stability
concern during stair climbing and
greater possiblity of human/operator
error.
Additionally, analysis of MDRs for
purposes of determining risks associated
with inherent characteristics of the
device should be viewed in light of the
intended population and environment
for use. As compared to other powered
patient-transport devices that are used
more regularly, portable stair-climbing
chairs are a less common option used to
transport patients, used more frequently
for emergencies or when a conventional
elevator is not an option. In this case,
there have only been three powered
portable stair-climbing chairs cleared
since 1990. Thus, the risks associated
with the inherent characteristics of the
device, as analyzed through infrequent
premarket submissions spanning over
the last 30 years, cannot be proved or
disapproved with reasonable certainty
from the MDR system due to the lack of
information about prevalence and
frequency of use. Therefore, this device,
as compared to the other referenced
exempted devices, does not present a
lower risk and a premarket review is
required to provide reasonable
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assurance of safety and effectivenss for
this device type.
B. Characteristics of the Device
Necessary for Its Safe and Effective
Performance Are Well Established
The petition states that characteristics
of the devices necessary for their safe
and effective performance are well
established as demonstrated by
adherence to the Quality System
Regulation (QSR) (21 CFR part 820) and
FDA-recognized consensus standards.
To illustrate, the petition compares
certain features of the subject devices to
other referenced devices exempt from
premarket notification. FDA does not
agree that adherence to the QSR and
FDA-recognized consensus standards or
that industry familiarity with
characteristics of the subject device
alone are adequate to provide assurance
of safety and effectiveness of the devices
or that the features of the referenced
devices exempt from premarket
notification are relevant to key
characteristics of the subject devices.
The consensus standards referenced
in the petition apply to devices
classified under § 890.5150(b), and not
just the subject device, powered
portable stair-climbing chair. Adherence
to consensus standards, as applicable to
powered portable stair-climbing
devices, would not be sufficient to
ensure the devices are safe and effective
throughout their lifecycle because
existing standards do not cover
important aspects of design (e.g., lift
mechanism), maintenance, alteration,
and repair. There are certain key design
characteristics, including the stairclimbing function, that can differ and
would need to be reviewed on a caseby-case basis. Additionally, FDA has
only cleared three portable stairclimbing chair devices with a different
design of the stair-climbing function
among the manufacturers, for instance
one uses a climbing foot on each of the
rear wheels while another uses a motor
and chain driven lifting frame
mechanism. Similarly, the other devices
used as comparisons have designs that
differ significantly from the cleared
portable stair-climbing chair devices.
The petition does not provide any
information to address how the safety
and effectiveness of these devices,
despite their design differences, can be
assured through adherence to QSR and
FDA recognized consensus standards
even where industry may be familiar
with characteristics of the subject
device. Due to the small volume of
devices cleared under the subject
regulation and lack of an FDArecognized consensus standards
covering all the design, maintenance,
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alteration, and repair features of these
devices, the characteristics of the
devices necessary for their safe and
effective performance currently are not
well established through existing
clearances or comparison to other
device types that are currently exempt
from premarket notification.
C. Changes in the Device That Could
Affect Safety and Effectiveness Will
Either Be Readily Detectable by Users by
Visual Examination or Other Means
Such as Routine Testing, Before Causing
Harm or Not Materially Increase the
Risk of Injury, Incorrect Diagnosis, or
Ineffective Treatment
The petition states that changes in the
devices that could affect safety and
effectiveness will either be readily
detectable by users or not materially
increase the risk of injury, incorrect
diagnosis, or ineffective treatment. This
statement is supported by referencing
how adequate adherence to control
processes under 21 CFR 820.30 and risk
management under FDA recognized
consensus standard International
Organization for Standards (ISO 14971
will adequately control safety and
effectiveness. The petition also
references the general labeling
requirements under 21 CFR part 801
and FDA recognized consensus standard
ISO 15223–1 for labeling symbols as
effective management of changes in the
device that could affect safety and
effectiveness detectability for users.
FDA does not agree that changes in
these devices that could affect safety
and effectiveness will either be readily
detectable by users or not materially
increase the risk of injury. Based on the
powered and portable nature of these
devices, and based on the designs of the
three devices FDA has cleared in this
category, FDA is aware of certain design
characteristics that could be changed
without being readily detectable by
users and could increase risk of injury.
For example, changes that would not
necessarily be apparent to an end user
could include, but would not be limited
to, the device’s motor, battery power
source, and internal electrical and
nonelectrical components. Such
changes may not be fully addressed by
control processes, risk management, and
labeling alone in providing readily
apparent detectability for device users,
especially for less visible changes. Risks
of injury that could be affected by
changes to these characteristics include,
but are not limited to, inadequate
battery performance and safety,
electromagnetic incompatibility
(emissions and immunity) and other
electrical safety, reduced resistance to
ignition of upholstered parts, users
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falling out of the device, and
insufficient mechanical strength of the
device and stair-climbing mechanism.
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D. Any Changes to the Device Would
Not Be Likely to Result in a Change in
the Device’s Classification
Lastly, the petition states that any
changes to the devices would not be
likely to result in a change in the
device’s classification. Specifically, the
petition states that the ‘‘device has been
on the market for several decades and is
well characterized and understood by
manufacturers and healthcare
professionals.’’ The petition then cites
to section 513(g) of the FD&C Act as a
mechanism to obtain the Agency’s
views about the classification and
applicable regulatory requirements for a
device that has been significantly
changed. As noted above, FDA does not
agree with petitioner that the subject
devices are well characterized at this
time, thus we cannot foresee whether, or
what, changes will result in the devices’
classification. While FDA agrees that
section 513(g) is an appropriate
mechanism to obtain the Agency’s
views about the classification and
applicable regulatory requirements of a
device, the mere fact that such an
optional feedback mechanism exists
may only contribute to, but would not
guarantee, the reasonable assurance of
safety and effectiveness of any
particular device. Additionally, because
FDA believes that a change to the device
would be likely to result in a change in
classification, FDA did not evaluate
petitioner’s contention that the
limitations on exemption under 21 CFR
890.9 would apply to any changes that
do not result in a change in
classification. Thus, the petitioner’s
response to this factor does not weigh in
favor of exemption from the
requirements of premarket notification.
For all the foregoing reasons, the
petition failed to demonstrate that
premarket notification is not necessary
to provide reasonable assurance of
safety and effectiveness for the subject
device type. Therefore, FDA denied the
petition request for exemption from
premarket notification requirements for
powered patient transport, all other
powered patient transport, and is
issuing this order setting forth the final
determination. Manufacturers of this
device type must continue to submit
and receive FDA clearance of a 510(k)
submission before marketing their
device, as well as comply with all other
applicable requirements under the
FD&C Act.
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V. Analysis of Environmental Impact
The Agency has determined under 21
CFR 25.30(h) 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.
VI. Paperwork Reduction Act of 1995
While this final order contains no
new collection of information, it does
refer to previously approved FDA
collections of information. Therefore,
clearance by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3521) is not required for this final order.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in 21 CFR part 820,
regarding quality system regulation,
have been approved under OMB control
number 0910–0073; the collections of
information in 21 CFR part 807, subpart
E, regarding premarket notification
submissions, have been approved under
OMB control number 0910–0120; and
the collections of information in 21 CFR
parts 800, 801, and 809, regarding
labeling, have been approved under
OMB control number 0910–0485.
Dated: December 3, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–26636 Filed 12–7–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF LABOR
NATIONAL FOUNDATION ON THE
ARTS AND HUMANITIES
National Endowment for the
Humanities
45 CFR Part 1177
RIN 3136–AA38
Claims Collection; Correction
National Endowment for the
Humanities; National Foundation on the
Arts and the Humanities.
AGENCY:
ACTION:
Direct final rule; correction.
The National Endowment for
the Humanities (NEH) is correcting a
direct final rule that published
November 24, 2021, in the Federal
Register. The final rule revised the NEH
Claims Collection regulation in
accordance with the Debt Collection
Improvement Act of 1996 (DCIA), as
implemented by the Department of
Justice (DOJ) and the Department of
Treasury (Treasury) in the revised
Federal Claims Collection Standards
(FCCS). NEH discovered two errors after
publications that could cause confusion
and is correcting those errors in this
document.
SUMMARY:
DATES:
Effective February 22, 2022.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Voyatzis, Deputy General
Counsel, Office of the General Counsel,
National Endowment for the
Humanities, 400 7th Street SW, Room
4060, Washington, DC 20506; (202) 606–
8322; gencounsel@neh.gov.
In FR Doc.
2021–23742, appearing in the Federal
Register of November 24, 2021, starting
on page 66964, make the following
corrections:
SUPPLEMENTARY INFORMATION:
Occupational Safety and Health
Administration
29 CFR Parts 1910, 1915, 1917, 1918,
1926, and 1928
[Docket No. OSHA–2021–0007]
§ 1177.9
[Corrected]
RIN 1218–AD42
1. On page 66967, in the second
column, designate the second paragraph
(e) as paragraph (f).
COVID–19 Vaccination and Testing;
Emergency Temporary Standard
§ 1177.24
■
[Corrected]
2. On page 66973 in the first column,
correct the paragraph designations ‘‘a.’’
and ‘‘b.’’ to read as ‘‘(a)’’ and ‘‘(b)’’.
■
Correction
In rule document 2021–26268,
appearing on page 68560 in the issue of
Friday, December 3, 2021, make the
following correction:
On page 68560, in the first column, in
the DATES section, on the third and
fourth lines, ‘‘86 FR 6140’’ should read,
‘‘86 FR 61402’’.
Authority: 31 U.S.C. 3711, 3716–3719;
Pub. L. 104–134; 31 CFR 900–904.
Dated: December 3, 2021.
Samuel Roth,
Attorney-Advisor, National Endowment for
the Humanities.
[FR Doc. C1–2021–26268 Filed 12–7–21; 8:45 am]
[FR Doc. 2021–26606 Filed 12–7–21; 8:45 am]
BILLING CODE 0099–10–D
BILLING CODE 7536–01–P
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]]>Agencies
[Federal Register Volume 86, Number 233 (Wednesday, December 8, 2021)]
[Rules and Regulations]
[Pages 69583-69586]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26636]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 890
[Docket No. FDA-2021-P-0424]
Medical Devices; Exemption From Premarket Notification: Powered
Patient Transport, All Other Powered Patient Transport
AGENCY: Food and Drug Administration, HHS.
ACTION: Final amendment; final order.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is publishing
an order setting forth the final determination of a petition requesting
exemption from premarket notification (510(k)) requirements for the
generic device type, powered patient transport, all other powered
patient transport (product code ILK), classified as class II devices.
These devices are motorized devices used to mitigate mobility
impairment caused by injury or other disease by moving a person from
one location or level to another, such as up and down flights of
stairs. These devices do not include motorized three-wheeled vehicles
or wheelchairs, and are distinct from the device type, powered patient
transport, powered patient stairway chair lifts, which is classified
separately within the same regulation (product code PCD). FDA is
publishing this order in accordance with procedures established in the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
DATES: This order is effective December 8, 2021.
FOR FURTHER INFORMATION CONTACT: Dan Reed, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm.1526, Silver Spring, MD 20993-0002, 240-402-4717.
SUPPLEMENTARY INFORMATION:
I. Statutory Background
Section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and its
implementing regulations in part 807, subpart E (21 CFR part 807,
subpart E) require persons who propose to begin the introduction or
delivery for introduction into interstate commerce for commercial
distribution of a device intended for human use to submit a 510(k) to
FDA. The device may not be marketed until FDA finds it ``substantially
equivalent'' within the meaning of section 513(i) of the FD&C Act (21
U.S.C. 360c(i)) to a legally marketed device that does not require
premarket approval.
On November 21, 1997, the President signed into law the Food and
Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L. 105-
115), section 206 of which added section 510(m) to the FD&C Act, which
was amended on December 13, 2016, by the 21st Century Cures Act (Cures
Act) (Pub. L. 114-255). Section 510(m)(1) of the FD&C Act, requires FDA
to publish in the Federal Register a list of each type of class II
device that does not require a report under section 510(k) of the FD&C
Act to provide reasonable assurance of safety and effectiveness.
Section 510(m) of the FD&C Act further provides that a 510(k) will no
longer be required for these devices upon the date of publication of
the list in the Federal Register. FDA published the required lists in
accordance with FDAMA and the Cures Act, in the Federal Register of
January 21, 1998 (63 FR 3142), and July 11, 2017 (82 FR 31976),
respectively.
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Section 510(m)(2) of the FD&C Act provides that FDA may exempt a
device from 510(k) requirements on its own initiative, or upon petition
of an interested person, if FDA determines that a 510(k) is not
necessary to provide assurance of the safety and effectiveness of the
device. This section requires FDA to publish in the Federal Register a
notice of intent to exempt a device, or of the petition, and to provide
a 60-day period for public comment. Within 120 days after the issuance
of the notice, FDA shall publish an order in the Federal Register
setting forth the final determination regarding the exemption of the
device that was the subject of the notice. If FDA fails to respond to a
petition under this section within 180 days of receiving it, the
petition shall be deemed granted.
FDA classified powered patient transport devices into class II
effective December 23, 1983 (48 FR 53032, November 23, 1983). All
powered patient transport devices were class II devices regulated under
Sec. 890.5150 (21 CFR 890.5150), product code ILK. In 2013, FDA
amended Sec. 890.5150 in response to a citizen petition requesting the
Agency exempt permanently mounted stairway chair lifts from premarket
notification requirements (78 FR 14015, March 4, 2013). In granting
this request, FDA defined a subset of powered patient transport devices
classified under new Sec. 890.5150(a), identified as ``powered patient
stairway chair lifts,'' product code PCD, and exempted this subset of
devices from 510(k) premarket notification requirements provided
certain conditions are met. The exemption did not affect ``all other
powered patient transport devices'' identified under new Sec.
890.5150(b), product code ILK. Under Sec. 890.5150(b), a powered
patient transport is a motorized device intended for use in mitigating
mobility impairment caused by injury or other disease by moving a
person from one location or level to another, such as up and down
flights of stairs (e.g., attendant-operated portable stair-climbing
chairs). This generic type of device does not include motorized three-
wheeled vehicles or wheelchairs.
II. Criteria for Exemption
There are a number of factors FDA may consider in order to
determine whether a 510(k) is necessary to provide reasonable assurance
of the safety and effectiveness of a class II device. FDA generally
considers the following factors to determine whether premarket
notification is necessary: (1) The device does not have a significant
history of false or misleading claims or risks associated with inherent
characteristics of the device (when making these determinations, FDA
has considered the risks associated with false or misleading claims,
and the frequency, persistence, cause or seriousness of the inherent
risks of the device); (2) characteristics of the device necessary for
its safe and effective performance are well established; (3) changes in
the device that could affect safety and effectiveness will either (a)
be readily detectable by users by visual examination or other means
such as routine testing, before causing harm, or (b) not materially
increase the risk of injury, incorrect diagnosis, or ineffective
treatment; and (4) any changes to the device would not be likely to
result in a change in the device's classification. FDA may also
consider that, even when exempting devices, these devices would still
be subject to the limitations on exemptions.
These factors are discussed in the guidance that the Agency issued
on February 19, 1998, entitled ``Procedures for Class II Device
Exemptions from Premarket Notification, Guidance for Industry and CDRH
Staff'' (Class II 510(k) Exemption Guidance). That guidance can be
obtained through the internet at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080199.pdf or by sending an email request to [email protected] to receive a copy of the document. Please use the
document number 159 to identify the guidance you are requesting.
III. Petition
On April 30, 2021, FDA received a petition requesting an exemption
from premarket notification for powered patient transport, all other
powered patient transport (see Docket No. FDA-2021-P-0424). These
devices are currently classified under Sec. 890.5150(b), powered
patient transport, all other powered patient transport. The
classification regulation is split into paragraphs (a) and (b) with
stairway chair lifts classified under Sec. 890.5150(a) (product code
PCD), exempt from premarket notification requirements provided certain
conditions are met, while all other powered patient transport devices
are classified in Sec. 890.5150(b) (product code ILK) and remain
subject to premarket notification requirements. Importantly, many
different devices are classified under the generic device-type within
Sec. 890.5150(b). The FDA review focused on ``all other powered
patient transport'' devices identified under Sec. 890.5150(b), and
specifically, powered portable stair-climbing chairs as described in
the petition (see Docket No. FDA-2021-P-0424).
In the Federal Register of June 15, 2021 (86 FR 31722), FDA
published a notice announcing that this petition had been received and
provided opportunity for interested persons to submit comments on the
petition by August 16, 2021. In the Federal Register of June 30, 2021
(86 FR 34770), FDA published a correction to the docket number, and, in
the Federal Register of July 23, 2021 (86 FR 39047), subsequently
extended the opportunity to submit comments on the petition to August
30, 2021. FDA received one comment that is unrelated to the petition
and, thus, outside the scope of this final order.
FDA completed review of the petition and assessed the need for
510(k) clearance for this type of device against the criteria laid out
in the Class II 510(k) Exemption Guidance. Based on this review, and
for the reasons described in section IV, FDA has determined that
premarket notification is necessary to provide a reasonable assurance
of the safety and effectiveness of powered patient transport, all other
powered patient transport, Sec. 890.5150(b)(2) (product code ILK).
Accordingly, FDA responded to the petition by letter dated October 19,
2021, denying the petition within the 180-day timeframe under section
510(m)(2) of the FD&C Act (see Docket No. FDA-2021-P-0424).
IV. Order
After reviewing the petition, FDA has determined that the petition
failed to provide information to demonstrate that premarket
notification is not necessary to provide reasonable assurance of the
safety and effectiveness of the device. FDA analyzed the petition
against the criteria laid out in the Class II 510(k) Exemption
Guidance.
A. The Device Does Not Have a Significant History of False or
Misleading Claims or Risks Associated With Inherent Characteristics of
the Device
The petition included a 5-year look at FDA medical device reports
(MDRs), the FDA medical device recall database, and the FDA warning
letter database using Sec. 890.5150, product code ILK and other
product codes for other device classifications, which are listed as
comparable device classifications to powered patient transport, all
other powered patient transport. While FDA does not have a concern
related to the absence of warning letters or recalls nor, more
generally, to a significant history of false or misleading claims, we
do not agree that the use of the device is well
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established without any reports of patient or user injury or that the
device does not have a significant history of risks associated with
inherent characteristics of the device solely based on a non-
substantial number of MDR reports of patient or user injury. Although
there have been no MDRs submitted to the Agency in the past 5 years for
powered portable stair-climbing chairs under product code ILK, since
September 15, 1998, FDA has received four MDRs related to powered
patient transport devices including two involving serious injury to the
patient, one of which involved both patient and operator injury.
The petition includes a comparison to other devices, but because
these other devices and powered portable stair-climbing chairs differ
in technological characteristics and safety profiles, a comparison of
the number of MDRs does not provide relevant information regarding the
history of risks associated with the inherent characteristics of
powered patient transports under Sec. 890.5150(b), or powered portable
stair-climbing chairs more specifically.
The petition also does not consider risks associated with powered
wheelchairs, which must also be analyzed given that the FDA-cleared
powered portable stair-climbing chairs adhere to wheelchair consensus
standards, and the unique stair-climbing functionality of the powered
portable stair-climbing chair can entail a higher degree of risk
related to stability concern during stair climbing and greater
possiblity of human/operator error.
Additionally, analysis of MDRs for purposes of determining risks
associated with inherent characteristics of the device should be viewed
in light of the intended population and environment for use. As
compared to other powered patient-transport devices that are used more
regularly, portable stair-climbing chairs are a less common option used
to transport patients, used more frequently for emergencies or when a
conventional elevator is not an option. In this case, there have only
been three powered portable stair-climbing chairs cleared since 1990.
Thus, the risks associated with the inherent characteristics of the
device, as analyzed through infrequent premarket submissions spanning
over the last 30 years, cannot be proved or disapproved with reasonable
certainty from the MDR system due to the lack of information about
prevalence and frequency of use. Therefore, this device, as compared to
the other referenced exempted devices, does not present a lower risk
and a premarket review is required to provide reasonable assurance of
safety and effectivenss for this device type.
B. Characteristics of the Device Necessary for Its Safe and Effective
Performance Are Well Established
The petition states that characteristics of the devices necessary
for their safe and effective performance are well established as
demonstrated by adherence to the Quality System Regulation (QSR) (21
CFR part 820) and FDA-recognized consensus standards. To illustrate,
the petition compares certain features of the subject devices to other
referenced devices exempt from premarket notification. FDA does not
agree that adherence to the QSR and FDA-recognized consensus standards
or that industry familiarity with characteristics of the subject device
alone are adequate to provide assurance of safety and effectiveness of
the devices or that the features of the referenced devices exempt from
premarket notification are relevant to key characteristics of the
subject devices.
The consensus standards referenced in the petition apply to devices
classified under Sec. 890.5150(b), and not just the subject device,
powered portable stair-climbing chair. Adherence to consensus
standards, as applicable to powered portable stair-climbing devices,
would not be sufficient to ensure the devices are safe and effective
throughout their lifecycle because existing standards do not cover
important aspects of design (e.g., lift mechanism), maintenance,
alteration, and repair. There are certain key design characteristics,
including the stair-climbing function, that can differ and would need
to be reviewed on a case-by-case basis. Additionally, FDA has only
cleared three portable stair-climbing chair devices with a different
design of the stair-climbing function among the manufacturers, for
instance one uses a climbing foot on each of the rear wheels while
another uses a motor and chain driven lifting frame mechanism.
Similarly, the other devices used as comparisons have designs that
differ significantly from the cleared portable stair-climbing chair
devices. The petition does not provide any information to address how
the safety and effectiveness of these devices, despite their design
differences, can be assured through adherence to QSR and FDA recognized
consensus standards even where industry may be familiar with
characteristics of the subject device. Due to the small volume of
devices cleared under the subject regulation and lack of an FDA-
recognized consensus standards covering all the design, maintenance,
alteration, and repair features of these devices, the characteristics
of the devices necessary for their safe and effective performance
currently are not well established through existing clearances or
comparison to other device types that are currently exempt from
premarket notification.
C. Changes in the Device That Could Affect Safety and Effectiveness
Will Either Be Readily Detectable by Users by Visual Examination or
Other Means Such as Routine Testing, Before Causing Harm or Not
Materially Increase the Risk of Injury, Incorrect Diagnosis, or
Ineffective Treatment
The petition states that changes in the devices that could affect
safety and effectiveness will either be readily detectable by users or
not materially increase the risk of injury, incorrect diagnosis, or
ineffective treatment. This statement is supported by referencing how
adequate adherence to control processes under 21 CFR 820.30 and risk
management under FDA recognized consensus standard International
Organization for Standards (ISO 14971 will adequately control safety
and effectiveness. The petition also references the general labeling
requirements under 21 CFR part 801 and FDA recognized consensus
standard ISO 15223-1 for labeling symbols as effective management of
changes in the device that could affect safety and effectiveness
detectability for users.
FDA does not agree that changes in these devices that could affect
safety and effectiveness will either be readily detectable by users or
not materially increase the risk of injury. Based on the powered and
portable nature of these devices, and based on the designs of the three
devices FDA has cleared in this category, FDA is aware of certain
design characteristics that could be changed without being readily
detectable by users and could increase risk of injury. For example,
changes that would not necessarily be apparent to an end user could
include, but would not be limited to, the device's motor, battery power
source, and internal electrical and nonelectrical components. Such
changes may not be fully addressed by control processes, risk
management, and labeling alone in providing readily apparent
detectability for device users, especially for less visible changes.
Risks of injury that could be affected by changes to these
characteristics include, but are not limited to, inadequate battery
performance and safety, electromagnetic incompatibility (emissions and
immunity) and other electrical safety, reduced resistance to ignition
of upholstered parts, users
[[Page 69586]]
falling out of the device, and insufficient mechanical strength of the
device and stair-climbing mechanism.
D. Any Changes to the Device Would Not Be Likely to Result in a Change
in the Device's Classification
Lastly, the petition states that any changes to the devices would
not be likely to result in a change in the device's classification.
Specifically, the petition states that the ``device has been on the
market for several decades and is well characterized and understood by
manufacturers and healthcare professionals.'' The petition then cites
to section 513(g) of the FD&C Act as a mechanism to obtain the Agency's
views about the classification and applicable regulatory requirements
for a device that has been significantly changed. As noted above, FDA
does not agree with petitioner that the subject devices are well
characterized at this time, thus we cannot foresee whether, or what,
changes will result in the devices' classification. While FDA agrees
that section 513(g) is an appropriate mechanism to obtain the Agency's
views about the classification and applicable regulatory requirements
of a device, the mere fact that such an optional feedback mechanism
exists may only contribute to, but would not guarantee, the reasonable
assurance of safety and effectiveness of any particular device.
Additionally, because FDA believes that a change to the device would be
likely to result in a change in classification, FDA did not evaluate
petitioner's contention that the limitations on exemption under 21 CFR
890.9 would apply to any changes that do not result in a change in
classification. Thus, the petitioner's response to this factor does not
weigh in favor of exemption from the requirements of premarket
notification.
For all the foregoing reasons, the petition failed to demonstrate
that premarket notification is not necessary to provide reasonable
assurance of safety and effectiveness for the subject device type.
Therefore, FDA denied the petition request for exemption from premarket
notification requirements for powered patient transport, all other
powered patient transport, and is issuing this order setting forth the
final determination. Manufacturers of this device type must continue to
submit and receive FDA clearance of a 510(k) submission before
marketing their device, as well as comply with all other applicable
requirements under the FD&C Act.
V. Analysis of Environmental Impact
The Agency has determined under 21 CFR 25.30(h) 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.
VI. Paperwork Reduction Act of 1995
While this final order contains no new collection of information,
it does refer to previously approved FDA collections of information.
Therefore, clearance by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521) is not
required for this final order. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 820, regarding quality system regulation,
have been approved under OMB control number 0910-0073; the collections
of information in 21 CFR part 807, subpart E, regarding premarket
notification submissions, have been approved under OMB control number
0910-0120; and the collections of information in 21 CFR parts 800, 801,
and 809, regarding labeling, have been approved under OMB control
number 0910-0485.
Dated: December 3, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26636 Filed 12-7-21; 8:45 am]
BILLING CODE 4164-01-P
