Medical Devices; Exemption From Premarket Notification; Class II Devices; Powered Wheeled Stretcher, 2018-2020 [2020-00295]
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2018
Federal Register / Vol. 85, No. 9 / Tuesday, January 14, 2020 / Rules and Regulations
PART 250—FORMS
1. The authority citation for part 250
continues to read as follows:
■
Authority: 15 U.S.C. 717–717w, 3301–
3432; 42 U.S.C. 7101–7352; 28 U.S.C. 2461
note.
2. Amend § 250.16 by revising
paragraph (e)(1) to read as follows:
■
§ 250.16 Format of compliance plan
transportation services and affiliate
transactions.
*
*
*
*
*
(e) Penalty for failure to comply. (1)
Any person who transports gas for
others pursuant to subpart B or G of part
284 of this chapter and who knowingly
violates the requirements of §§ 358.4
and 358.5 of this chapter, this section,
or § 284.13 of this chapter will be
subject, pursuant to sections 311(c), 501,
and 504(b)(6) of the Natural Gas Policy
Act of 1978, to a civil penalty, which
the Commission may assess, of not more
than $1,291,894 for any one violation.
*
*
*
*
*
PART 385—RULES OF PRACTICE AND
PROCEDURE
4. Revise § 385.1504(a) to read as
follows:
■
Maximum civil penalty (Rule
(a) Except as provided in paragraph
(b) of this section, the Commission may
assess a civil penalty of up to $23,331
for each day that the violation
continues.
*
*
*
*
*
■ 5. Revise § 385.1602 to read as
follows:
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§ 385.1602 Civil penalties, as adjusted
(Rule 1602).
The current inflation-adjusted civil
monetary penalties provided by law
within the jurisdiction of the
Commission are:
(a) 15 U.S.C. 3414(b)(6)(A)(i), Natural
Gas Policy Act of 1978: $1,291,894.
(b) 16 U.S.C. 823b(c), Federal Power
Act: $23,331 per day.
(c) 16 U.S.C. 825n(a), Federal Power
Act: $3,047.
(d) 16 U.S.C. 825o–1(b), Federal
Power Act: $1,291,894 per day.
(e) 15 U.S.C. 717t–1, Natural Gas Act:
$1,291,894 per day.
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BILLING CODE 6717–01–P
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:
ACTION:
Authority: 5 U.S.C. 551–557; 15 U.S.C.
717–717w, 3301–3432; 16 U.S.C. 791a–825v,
2601–2645; 28 U.S.C. 2461; 31 U.S.C 3701,
9701; 42 U.S.C. 7101–7352, 16441, 16451–
16463; 49 U.S.C. 60502; 49 App. U.S.C. 1–85
(1988); 28 U.S.C. 2461 note (1990); 28 U.S.C.
2461 note (2015).
VerDate Sep<11>2014
[FR Doc. 2020–00239 Filed 1–13–20; 8:45 am]
Food and Drug Administration,
HHS.
3. The authority citation for part 385
is revised to read as follows:
■
§ 385.1504
1504).
(f) 49 App. U.S.C. 6(10) (1988),
Interstate Commerce Act: $1,352 per
offense and $68 per day after the first
day.
(g) 49 App. U.S.C. 16(8) (1988),
Interstate Commerce Act: $13,525 per
day.
(h) 49 App. U.S.C. 19a(k) (1988),
Interstate Commerce Act: $1,352 per
day.
(i) 49 App. U.S.C. 20(7)(a) (1988),
Interstate Commerce Act: $1,352 per
day.
Final amendment; final order.
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 batterypowered 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,
eric.franca@fda.hhs.gov.
SUMMARY:
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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-calendarday 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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Federal Register / Vol. 85, No. 9 / Tuesday, January 14, 2020 / Rules and Regulations
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 CDRHGuidance@fda.hhs.gov to receive a copy
of the document. Please use the
document number 159 to identify the
guidance you are requesting.
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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
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
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16:28 Jan 13, 2020
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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.
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
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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2019
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
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Federal Register / Vol. 85, No. 9 / Tuesday, January 14, 2020 / Rules and Regulations
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
1. The authority citation for part 890
continues to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
2. In § 890.3690, revise paragraph (b)
to read as follows:
■
§ 890.3690
Powered wheeled stretcher.
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*
*
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*
(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 § 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;
VerDate Sep<11>2014
16:28 Jan 13, 2020
Jkt 250001
(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 skincontacting 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
DEPARTMENT OF STATE
22 CFR Parts 35, 103, 127, and 138
[Public Notice: 10992]
RIN 1400–AF00
Department of State 2020 Civil
Monetary Penalties Inflationary
Adjustment
Department of State.
Final rule.
AGENCY:
ACTION:
This final rule is issued to
adjust the civil monetary penalties
(CMP) for regulatory provisions
maintained and enforced by the
Department of State. The revised CMP
adjusts the amount of civil monetary
penalties assessed by the Department of
State based on the December 2019
SUMMARY:
PO 00000
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guidance from the Office of
Management and Budget. The new
amounts will apply only to those
penalties assessed on or after the
effective date of this rule, regardless of
the date on which the underlying facts
or violations occurred.
DATES: This final rule is effective on
January 14, 2020.
FOR FURTHER INFORMATION CONTACT:
Alice Kottmyer, Attorney-Adviser,
Office of Management, kottmyeram@
state.gov. ATTN: Regulatory Change,
CMP Adjustments, (202) 647–2318.
SUPPLEMENTARY INFORMATION: The
Federal Civil Penalties Inflation
Adjustment Act of 1990, Public Law
101–410, as amended by the Debt
Collection Improvement Act of 1996,
Public Law 104–134, required the head
of each agency to adjust its CMPs for
inflation no later than October 23, 1996
and required agencies to make
adjustments at least once every four
years thereafter. The Federal Civil
Penalties Inflation Adjustment Act
Improvements Act of 2015, Section 701
of Public Law 114–74 (the 2015 Act)
further amended the 1990 Act by
requiring agencies to adjust CMPs, if
necessary, pursuant to a ‘‘catch-up’’
adjustment methodology prescribed by
the 2015 Act, which mandated that the
catch-up adjustment take effect no later
than August 1, 2016. Additionally, the
2015 Act required agencies to make
annual adjustments to their respective
CMPs in accordance with guidance
issued by the Office of Management and
Budget (OMB).
Based on these statutes, the
Department of State (the Department)
published a final rule in June 2016 to
implement the ‘‘catch-up’’ provisions;
and annual updates to its CMPs in
January 2017, January 2018, and March
2019 (delayed due to the government
shutdown).
On December 16, 2019, OMB notified
agencies that the annual cost-of-living
adjustment multiplier for 2020, based
on the Consumer Price Index, is
1.01764. Additional information may be
found in OMB Memorandum M–20–05,
at: https://www.whitehouse.gov/wpcontent/uploads/2019/12/M-20-05.pdf.
This final rule amends Department
CMPs for fiscal year 2019.
Overview of the Areas Affected by This
Rule
Within the Department of State (title
22, Code of Federal Regulations), this
rule affects four areas:
(1) Part 35, which implements the
Program Fraud Civil Remedies Act of
1986 (PFCRA), codified at 31 U.S.C.
3801–3812;
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]]>Agencies
[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.
-----------------------------------------------------------------------
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
[[Page 2019]]
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
