[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.

[[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 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

[[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