Rule2021-26636
Medical Devices; Exemption From Premarket Notification: Powered Patient Transport, All Other Powered Patient Transport
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Published
December 8, 2021
Effective
December 8, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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).
Full Text
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<title>Federal Register, Volume 86 Issue 233 (Wednesday, December 8, 2021)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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.
[[Page 69584]]
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 <a href="https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080199.pdf">https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080199.pdf</a> or by sending an email request to <a href="/cdn-cgi/l/email-protection#95d6d1c7ddb8d2e0fcf1f4fbf6f0d5f3f1f4bbfdfde6bbf2fae3"><span class="__cf_email__" data-cfemail="f5b6b1a7bdd8b2809c91949b9690b5939194db9d9d86db929a83">[email protected]</span></a> 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
[[Page 69585]]
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
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