[Federal Register Volume 85, Number 9 (Tuesday, January 14, 2020)]
[Rules and Regulations]
[Pages 2018-2020]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00295]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 890

[Docket No. FDA-2019-P-3347]


Medical Devices; Exemption From Premarket Notification; Class II 
Devices; Powered Wheeled Stretcher

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 granting a petition requesting exemption from premarket 
notification (510(k)) requirements for powered wheeled stretchers 
(product code INK). These devices are battery-powered tables with 
wheels that are intended for medical purposes for use by patients who 
are unable to propel themselves independently and who must maintain a 
prone or supine position for prolonged periods because of skin ulcers 
or contractures (muscle contractions). This order exempts powered 
wheeled stretchers, class II devices, from 510(k) requirements, subject 
to certain conditions for exemption. This exemption from 510(k) 
requirements is immediately in effect for powered wheeled stretchers. 
FDA is publishing this order in accordance with the section of the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) permitting the 
exemption of a device from the requirement to submit a 510(k).

DATES: This order is effective January 14, 2020.

FOR FURTHER INFORMATION CONTACT: Eric Franca, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1655, Silver Spring, MD 20993-0002, 301-796-4505, 
[email protected].

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 (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 (Pub. L. 
114-255). Section 510(m)(1) of the FD&C Act requires FDA to publish in 
the Federal Register a notice that contains 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 of the device. 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 that list in the Federal Register of January 21, 1998 (63 FR 
3142).
    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 assure 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-
calendar-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.

II. Criteria for Exemption

    There are a number of factors FDA may consider to determine whether 
a 510(k) is necessary to assure the safety and effectiveness of a class 
II device. These factors are discussed in the guidance that the Agency 
issued on

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February 19, 1998, entitled ``Procedures for Class II Device Exemptions 
from Premarket Notification'' (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 July 10, 2019, FDA received a petition requesting an exemption 
from premarket notification for powered wheeled stretchers (see Docket 
No. FDA-2019-P-3347). These devices are currently classified under 21 
CFR 890.3690, powered wheeled stretchers.
    In the Federal Register of September 16, 2019 (84 FR 48623), FDA 
published a notice announcing that this petition had been received and 
provided opportunity for interested persons to submit comments on the 
petition by November 15, 2019. FDA received no comments.
    FDA has 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, FDA believes that premarket 
notification is not necessary to assure the safety and effectiveness of 
the device, as long as certain conditions are met. FDA believes that 
the risks posed by the device and the characteristics of the device 
necessary for its safe and effective performance are well established. 
FDA believes that changes in the device that could affect safety and 
effectiveness will be readily detectable by visual examination. 
Therefore, after reviewing the petition, FDA has determined that 
premarket notification is not necessary to assure the safety and 
effectiveness of powered wheeled stretchers, as long as the conditions 
in section IV are met. FDA responded to the petition by letter dated 
December 31, 2019, to inform the petitioner of this decision within the 
180-day timeframe under section 510(m)(2) of the FD&C Act.

IV. Conditions for Exemption

    This final order provides conditions for exemption from premarket 
notification for the powered wheeled stretcher.\1\ The conditions that 
must be met for the device to be 510(k)-exempt are as follows: 
Appropriate analysis and nonclinical testing must demonstrate that the 
safety controls are adequate to ensure safe use of the device and 
prevent user falls from the device in the event of a device failure; 
appropriate analysis and nonclinical testing must demonstrate the 
ability of the device to withstand the rated user weight load with an 
appropriate factor of safety; appropriate analysis and nonclinical 
testing must demonstrate the longevity of the device to withstand 
external forces applied to the device and provide the user with an 
expected service life of the device; appropriate analysis and 
nonclinical testing must demonstrate proper environments of use and 
storage of the device to maximize the longevity of the device; 
appropriate analysis and nonclinical testing (such as outlined in 
appropriate FDA-recognized consensus standards) must validate 
electromagnetic compatibility and electrical safety; appropriate 
analysis and nonclinical testing (such as outlined in appropriate FDA-
recognized consensus standards) must validate that the skin-contacting 
components of the device are biocompatible; appropriate analysis and 
nonclinical testing (such as outlined in appropriate FDA-recognized 
consensus standards) must validate the software life cycle and that all 
processes, activities, and tasks are implemented and documented; 
appropriate analysis and nonclinical testing must validate that the 
device components are found to be nonflammable; appropriate analysis 
and nonclinical testing (such as outlined in appropriate FDA-recognized 
consensus standards) must validate that the battery in the device 
performs as intended over the anticipated service life of the device; 
adequate labeling is provided to the user to document proper use and 
maintenance of the device to ensure safe use of the device in the 
intended use environment; and appropriate risk assessment including, 
but not limited to, evaluating the dimensional limits of the gaps in 
hospital beds and mitigation strategy to reduce entrapment.
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    \1\ FDA notes that the ``ACTION'' caption for this final order 
is styled as ``Final amendment; final order,'' rather than ``Final 
order.'' Beginning in December 2019, this editorial change was made 
to indicate that the document ``amends'' the Code of Federal 
Regulations. The change was made in accordance with the Office of 
Federal Register's (OFR) interpretations of the Federal Register Act 
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and 
parts 21 and 22), and the Document Drafting Handbook.
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    A number of these conditions involve ``appropriate analysis and 
nonclinical testing,'' the details of which are outlined in, among 
other places, certain FDA-recognized consensus standards. The following 
is a list of FDA recognized consensus standards that may be used to 
meet the listed conditions of exemption. Specifically, those standards 
include FDA-recognized editions of:

 ANSI/AAMI ES60601-1: Medical electrical equipment--Part 1: 
General requirements for basic safety and essential performance
 ANSI/AAMI/IEC 60601-1-2: Medical electrical equipment--Part 1-
2: General requirements for basic safety and essential performance--
Collateral Standard: Electromagnetic disturbances--Requirements and 
tests
 ISO 7176-14: Wheelchairs--Part 14: Power and control systems 
for electrically powered wheelchairs and scooters--Requirements and 
test methods
 ISO 7176-21: Wheelchairs--Part 21: Requirements and test 
methods for electromagnetic compatibility of electrically powered 
wheelchairs and scooters, and battery chargers
 ANSI/AAMI/ISO 10993-1: Biological evaluation of medical 
devices--Part 1: Evaluation and testing within a risk management 
process
 ANSI/AAMI/ISO 10993-5: Biological evaluation of medical 
devices--Part 5: Tests for in vitro cytotoxicity
 AAMI/ANSI/ISO 10993-10: Biological evaluation of medical 
devices--Part 10: Tests for irritation and skin sensitization
 IEC 62304: Medical device software--Software life cycle 
processes
 ISO 7176-25: Wheelchairs--Part 25: Batteries and chargers for 
powered wheelchairs

    We also recommend you consider FDA's guidance entitled ``Hospital 
Bed System Dimensional and Assessment Guidance to Reduce Entrapment'' 
when considering the appropriate risk assessment referenced in the 
conditions set forth above.
    Firms are now exempt from 510(k) requirements for powered wheeled 
stretchers as long as they meet these conditions, subject to the 
limitations on exemption in 21 CFR 890.9. Firms must comply with the 
particular conditions set forth in the conditions for exemption or 
submit and receive clearance for a 510(k) prior to marketing.

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

    This final order refers to previously approved FDA collections of

[[Page 2020]]

information. These collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (44 U.S.C. 3501-3521). The collections of information in 21 
CFR part 820, regarding quality system regulation, have been approved 
under OMB control number 0910-0073; the collections of information in 
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 801 and 809, regarding labeling, have 
been approved under OMB control number 0910-0485.

List of Subjects in 21 CFR Part 890

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
890 is amended as follows:

PART 890--PHYSICAL MEDICINE DEVICES

0
1. The authority citation for part 890 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.


0
2. In Sec.  890.3690, revise paragraph (b) to read as follows:


Sec.  890.3690  Powered wheeled stretcher.

* * * * *
    (b) Classification. Class II (performance standards). The powered 
wheeled stretcher is exempt from premarket notification procedures in 
subpart E of part 807 of this chapter, subject to Sec.  890.9, and the 
following conditions for exemption:
    (1) Appropriate analysis and nonclinical testing must demonstrate 
that the safety controls are adequate to ensure safe use of the device 
and prevent user falls from the device in the event of a device 
failure;
    (2) Appropriate analysis and nonclinical testing must demonstrate 
the ability of the device to withstand the rated user weight load with 
an appropriate factor of safety;
    (3) Appropriate analysis and nonclinical testing must demonstrate 
the longevity of the device to withstand external forces applied to the 
device and provide the user with an expected service life of the 
device;
    (4) Appropriate analysis and nonclinical testing must demonstrate 
proper environments of use and storage of the device to maximize the 
longevity of the device;
    (5) Appropriate analysis and nonclinical testing (such as outlined 
in appropriate FDA-recognized consensus standards) must validate 
electromagnetic compatibility and electrical safety;
    (6) Appropriate analysis and nonclinical testing (such as outlined 
in appropriate FDA-recognized consensus standards) must validate that 
the skin-contacting components of the device are biocompatible;
    (7) Appropriate analysis and nonclinical testing (such as outlined 
in appropriate FDA-recognized consensus standards) must validate the 
software life cycle and that all processes, activities, and tasks are 
implemented and documented;
    (8) Appropriate analysis and nonclinical testing must validate that 
the device components are found to be nonflammable;
    (9) Appropriate analysis and nonclinical testing (such as outlined 
in appropriate FDA-recognized consensus standards) must validate that 
the battery in the device performs as intended over the anticipated 
service life of the device;
    (10) Adequate labeling is provided to the user to document proper 
use and maintenance of the device to ensure safe use of the device in 
the intended use environment; and
    (11) Appropriate risk assessment including, but not limited to, 
evaluating the dimensional limits of the gaps in hospital beds, and 
mitigation strategy to reduce entrapment.

    Dated: January 7, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-00295 Filed 1-13-20; 8:45 am]
 BILLING CODE 4164-01-P