Medical Devices; Physical Medicine Devices; Classification of the Powered Lower Extremity Exoskeleton; Republication, 25226-25230 [2015-10332]
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Federal Register / Vol. 80, No. 85 / Monday, May 4, 2015 / Rules and Regulations
XI. Effective Date
The preamble to the proposed rule
stated that a final rule deeming that any
seasonal and decorative lighting product
that does not conform to sections 6, 7,
15, 71, 79, and SB15 of UL 588 with
regard to minimum wire size, sufficient
strain relief, and overcurrent protection
is a substantial product hazard would
take effect 30 days after publication of
the rule in the Federal Register. We
received no comments on the effective
date. Accordingly, the final rule will
apply to seasonal and decorative
lighting products imported or
introduced into commerce on June 3,
2015.
List of Subjects in 16 CFR Part 1120
Administrative practice and
procedure, Clothing, Consumer
protection, Household appliances,
Imports, Incorporation by reference,
Infants and children, Lighting.
For the reasons stated above, and
under the authority of 15 U.S.C. 2064(j),
5 U.S.C. 553, and section 3 of Public
Law 110–314, 122 Stat. 3016 (August
14, 2008), the Consumer Product Safety
Commission amends 16 CFR part 1120
to read as follows:
PART 1120—SUBSTANTIAL PRODUCT
HAZARD LIST
1. The authority citation for part 1120
continues to read as follows:
■
Authority: 15 U.S.C. 2064(j).
2. In § 1120.2, add paragraph (d) to
read as follows:
■
§ 1120.2
Definitions.
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*
*
*
*
*
(d) Seasonal and decorative lighting
product means portable, plugconnected, temporary-use lighting
products and accessories that have a
nominal 120 volt input voltage rating.
Lighting products within the scope of
the rule are factory-assembled with
push-in, midget- or miniature-screw
base lampholders connected in series or
with candelabra- or intermediate-screw
base lampholders connected in parallel,
directly across the 120 volt input. Such
lighting products include lighted
decorative outfits, such as stars,
wreathes, candles without shades, light
sculptures, blow-molded (plastic)
figures, and animated figures. Lighting
products outside the scope of the rule
include: Battery-operated products;
solar-powered products; products that
operate from a transformer or lowvoltage power supply; flexible lighting
products incorporating non-replaceable
series and series/parallel connected
lamps enclosed within a flexible
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polymeric tube or extrusion; and
portable electric lamps that are used to
illuminate seasonal decorations.
■ 3. In § 1120.3, republish the
introductory text, revise paragraphs (a)
and (b)(1), and add paragraph (c), to
read as follows:
§ 1120.3 Products deemed to be
substantial product hazards.
The following products or class of
products shall be deemed to be
substantial product hazards under
section 15(a)(2) of the CPSA:
(a) Hand-supported hair dryers that
do not provide integral immersion
protection in compliance with the
requirements of section 5 of UL 859, or
section 6 of UL 1727 (incorporated by
reference, see § 1120.4).
(b)(1) Children’s upper outerwear in
sizes 2T to 16 or the equivalent, and
having one or more drawstrings, that is
subject to, but not in conformance with,
the requirements of ASTM F 1816–97
(incorporated by reference, see
§ 1120.4).
*
*
*
*
*
(c) Seasonal and decorative lighting
products that lack one or more of the
following characteristics in
conformance with requirements in
sections 6, 7, 15, 71, 79, and SB15 of UL
588 (incorporated by reference, see
§ 1120.4):
(1) Minimum wire size requirements
in section 6 of UL 588;
(2) Sufficient strain relief
requirements in sections 15, 71, 79, and
SB15 of UL 588; or
(3) Overcurrent protection
requirements in section 7 of UL 588.
■ 4. Add § 1120.4 to read as follows:
§ 1120.4 Standards incorporated by
reference.
(a) The standards required in this part
are incorporated by reference (‘‘IBR’’)
into this section with the approval of
the Director of the Federal Register
under 5 U.S.C. 552(a) and 1 CFR part 51.
You may inspect all approved material
at the Office of the Secretary, U.S.
Consumer Product Safety Commission,
Room 820, 4330 East West Highway,
Bethesda, MD 20814, telephone 301–
504–7923, or at the National Archives
and Records Administration (‘‘NARA’’).
For information on the availability of
this material at NARA, call 202–741–
6030, or go to: https://www.archives.gov/
federal-register/cfr/ibr-locations.html.
(b) ASTM International, 100 Barr
Harbor Drive, P.O. Box C700, West
Conshohocken, PA 19428–2959 USA,
telephone: 610–832–9585; https://
www2.astm.org/.
(1) ASTM F 1816–97, Standard Safety
Specification for Drawstrings on
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Children’s Upper Outerwear, approved
June 10, 1997, published August 1998
(‘‘ASTM F 1816–97’’), IBR approved for
§ 1120.3(b).
(2) [Reserved]
(c) Underwriters Laboratories, Inc
(‘‘UL’’), 333 Pfingsten Road, Northbrook,
IL 60062 or through UL’s Web site:
www.UL.com.
(1) UL 588, Standard for Safety for
Seasonal and Holiday Decorative
Products, 18th Edition, approved
August 21, 2000 (‘‘UL 588’’), IBR
approved for § 1120.3(c).
(2) UL 859, Standard for Safety for
Household Electric Personal Grooming
Appliances, 10th Edition, approved
August 30, 2002, and revised through
June 3, 2010 (‘‘UL 859’’), IBR approved
for § 1120.3(a).
(3) UL 1727, Standard for Safety for
Commercial Electric Personal Grooming
Appliances, 4th Edition, approved
March 25, 1999, and revised through
June 25, 2010 (‘‘UL 1727’’), IBR
approved for § 1120.3(a).
Alberta E. Mills,
Acting Secretary, Consumer Product Safety
Commission.
[FR Doc. 2015–10342 Filed 5–1–15; 8:45 am]
BILLING CODE 6355–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 890
[Docket No. FDA–2014–N–1903]
Medical Devices; Physical Medicine
Devices; Classification of the Powered
Lower Extremity Exoskeleton;
Republication
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final order; republication.
The Food and Drug
Administration (FDA or the Agency) is
republishing in its entirety a final order
entitled ‘‘Medical Devices; Physical
Medicine Devices; Classification of the
Powered Lower Extremity Exoskeleton’’
that published in the Federal Register
on February 24, 2015. FDA is
republishing to correct an inadvertent
omission of information. FDA is
classifying the powered lower extremity
exoskeleton into class II (special
controls). The special controls that will
apply to the device are identified in this
order and will be part of the codified
language for the powered lower
extremity exoskeleton’s classification.
The Agency is classifying the device
SUMMARY:
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Federal Register / Vol. 80, No. 85 / Monday, May 4, 2015 / Rules and Regulations
into class II (special controls) in order
to provide a reasonable assurance of
safety and effectiveness of the device.
DATES: This order is effective May 4,
2015. The classification was applicable
on June 26, 2014.
FOR FURTHER INFORMATION CONTACT:
Michael Hoffmann, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 1434, Silver Spring,
MD 20993–0002, 301–796–6476,
Michael.Hoffmann@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In accordance with section 513(f)(1) of
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C.
360c(f)(1)), devices that were not in
commercial distribution before May 28,
1976 (the date of enactment of the
Medical Device Amendments of 1976),
generally referred to as postamendments
devices, are classified automatically by
statute into class III without any FDA
rulemaking process. These devices
remain in class III and require
premarket approval, unless and until
the device is classified or reclassified
into class I or II, or FDA issues an order
finding the device to be substantially
equivalent, in accordance with section
513(i) of the FD&C Act, to a predicate
device that does not require premarket
approval. The Agency determines
whether new devices are substantially
equivalent to predicate devices by
means of premarket notification
procedures in section 510(k) of the
FD&C Act (21 U.S.C. 360(k)) and part
807 (21 CFR part 807) of the regulations.
Section 513(f)(2) of the FD&C Act, as
amended by section 607 of the Food and
Drug Administration Safety and
Innovation Act (Pub. L. 112–144),
provides two procedures by which a
person may request FDA to classify a
device under the criteria set forth in
section 513(a)(1). Under the first
procedure, the person submits a
premarket notification under section
510(k) of the FD&C Act for a device that
has not previously been classified and,
within 30 days of receiving an order
classifying the device into class III
under section 513(f)(1) of the FD&C Act,
the person requests a classification
under section 513(f)(2). Under the
second procedure, rather than first
submitting a premarket notification
under section 510(k) of the FD&C Act
and then a request for classification
under the first procedure, the person
determines that there is no legally
marketed device upon which to base a
determination of substantial
equivalence and requests a classification
under section 513(f)(2) of the FD&C Act.
If the person submits a request to
classify the device under this second
procedure, FDA may decline to
undertake the classification request if
FDA identifies a legally marketed device
that could provide a reasonable basis for
review of substantial equivalence with
the device or if FDA determines that the
device submitted is not of ‘‘lowmoderate risk’’ or that general controls
would be inadequate to control the risks
and special controls to mitigate the risks
cannot be developed.
In response to a request to classify a
device under either procedure provided
by section 513(f)(2) of the FD&C Act,
FDA will classify the device by written
order within 120 days. This
classification will be the initial
classification of the device.
On June 22, 2013, Argo Medical
Technologies, Inc., submitted a request
for classification of the ReWalk under
section 513(f)(2) of the FD&C Act. The
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manufacturer recommended that the
device be classified into class II (Ref. 1).
In accordance with section 513(f)(2) of
the FD&C Act, FDA reviewed the
request in order to classify the device
under the criteria for classification set
forth in section 513(a)(1). FDA classifies
devices into class II if general controls
by themselves are insufficient to
provide reasonable assurance of safety
and effectiveness, but there is sufficient
information to establish special controls
to provide reasonable assurance of the
safety and effectiveness of the device for
its intended use. After review of the
information submitted in the request,
FDA determined that the device can be
classified into class II with the
establishment of special controls. FDA
believes these special controls, in
addition to general controls, will
provide reasonable assurance of the
safety and effectiveness of the device.
Therefore, on June 26, 2014, FDA
issued an order to the requestor
classifying the device into class II. FDA
is codifying the classification of the
device by adding 21 CFR 890.3480.
Following the effective date of this
final classification order, any firm
submitting a premarket notification
(510(k)) for a powered lower extremity
exoskeleton will need to comply with
the special controls named in this final
order. The device is assigned the generic
name powered lower extremity
exoskeleton, and it is identified as a
prescription device that is composed of
an external, powered, motorized
orthosis that is placed over a person’s
paralyzed or weakened limbs for
medical purposes.
FDA has identified the following risks
to health associated specifically with
this type of device, as well as the
measures required to mitigate these
risks in table 1.
TABLE 1—POWERED LOWER EXTREMITY EXOSKELETON RISKS AND MITIGATION MEASURES
Mitigation measure
Instability, falls, and associated injuries ...................................................
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Identified risk
Clinical testing
Training
Software verification, validation, and hazard analysis
Wireless testing
Electromagnetic compatibility (EMC) and electromagnetic interference
(EMI) testing
Electrical safety testing
Design characteristics
Non-clinical performance testing
Water/particle ingress testing
Durability testing
Battery testing
Labeling
Clinical testing
Training
Labeling
Clinical testing
Training
Bruising, skin abrasion, pressure sores, soft tissue injury .......................
Diastolic hypertension and changes in blood pressure, and heart rate ..
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Federal Register / Vol. 80, No. 85 / Monday, May 4, 2015 / Rules and Regulations
TABLE 1—POWERED LOWER EXTREMITY EXOSKELETON RISKS AND MITIGATION MEASURES—Continued
Identified risk
Mitigation measure
Adverse tissue reaction ............................................................................
Premature battery failure ..........................................................................
Interference with other electrical equipment/devices ...............................
Burns, electrical shock .............................................................................
Device malfunction resulting in unanticipated operation (e.g., device
stoppage, unintended movement).
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Use error ...................................................................................................
FDA believes that the following
special controls, in combination with
the general controls, address these risks
to health and provide reasonable
assurance of the safety and
effectiveness:
• Elements of the device materials
that may contact the patient must be
demonstrated to be biocompatible.
• Appropriate analysis/testing must
validate electronic compatibility/
interference (EMC/EMI), electrical
safety, thermal safety, mechanical
safety, battery performance and safety,
and wireless performance, if applicable.
• Appropriate software verification,
validation, and hazard analysis must be
performed.
• Design characteristics must ensure
geometry and materials composition are
consistent with intended use.
• Non-clinical performance testing
must demonstrate that the device
performs as intended under anticipated
conditions of use. Performance testing
must include:
Æ Mechanical bench testing
(including durability testing) to
demonstrate that the device will
withstand forces, conditions, and
environments encountered during use;
Æ simulated use testing (i.e., cyclic
loading testing) to demonstrate
performance of device commands and
safeguard under worst case conditions
and after durability testing;
Æ verification and validation of
manual override controls are necessary,
if present;
Æ the accuracy of device features and
safeguards; and
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Labeling
Biocompatibility assessment
Battery testing
Labeling
EMC/EMI testing
Labeling
Electrical safety testing
Thermal testing
Labeling
Clinical testing
Non-clinical performance testing
Training
Software verification, validation, and hazard analysis
Electrical safety testing
Battery testing
Water/particle ingress testing
Wireless testing
EMC/EMI testing
Flammability testing
Labeling
Clinical testing
Training
Labeling
Æ device functionality in terms of
flame retardant materials, liquid/
particle ingress prevention, sensor and
actuator performance, and motor
performance.
• Clinical testing must demonstrate a
reasonable assurance of safe and
effective use and capture any adverse
events observed during clinical use
when used under the proposed
conditions of use, which must include
considerations for:
Æ Level of supervision necessary and
Æ environment of use (e.g., indoors
and/or outdoors), including obstacles
and terrain representative of the
intended use environment.
• A training program must be
included with sufficient educational
elements so that upon completion of
training program, the clinician, user,
and companion can:
Æ Identify the safe environments for
device use,
Æ use all safety features of device, and
Æ operate the device in simulated or
actual use environments representative
of indicated environments and use.
• Labeling for the Physician and User
must include the following:
Æ Appropriate instructions, warning,
cautions, limitations, and information
related to the necessary safeguards of
the device, including warning against
activities and environments that may
put the user at greater risk;
Æ specific instructions and the
clinical training needed for the safe use
of the device, which includes:
D Instructions on assembling the
device in all available configurations;
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D instructions on fitting the patient;
D instructions and explanations of all
available programs and how to program
the device;
D instructions and explanation of all
controls, input, and outputs;
D instructions on all available modes
or states of the device;
D instructions on all safety features of
the device; and
D instructions for properly
maintaining the device;
Æ Information on the patient
population for which the device has
been demonstrated to have a reasonable
assurance of safety and effectiveness;
Æ pertinent non-clinical testing
information (e.g., EMC, battery
longevity); and
Æ a detailed summary of the clinical
testing including:
D Adverse events encountered under
use conditions,
D summary of study outcomes and
endpoints, and
D information pertinent to use of the
device including the conditions under
which the device was studied (e.g., level
of supervision or assistance, and
environment of use (e.g., indoors and/or
outdoors) including obstacles and
terrain).
Powered lower extremity exoskeleton
devices are restricted to patient use only
upon the authorization of a practitioner
licensed by law to administer or use the
device; see 21 CFR 801.109 (Prescription
devices).
Section 510(m) of the FD&C Act
provides that FDA may exempt a class
II device from the premarket notification
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Federal Register / Vol. 80, No. 85 / Monday, May 4, 2015 / Rules and Regulations
requirements under section 510(k) of the
FD&C Act if FDA determines that
premarket notification is not necessary
to provide reasonable assurance of the
safety and effectiveness of the device.
For this type of device, FDA has
determined that premarket notification
is necessary to provide reasonable
assurance of the safety and effectiveness
of the device. Therefore, this device
type is not exempt from premarket
notification requirements. Persons who
intend to market this type of device
must submit to FDA a premarket
notification, prior to marketing the
device, which contains information
about the powered lower extremity
exoskeleton they intend to market.
II. Environmental Impact
The Agency has determined under 21
CFR 25.34(b) 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.
III. Paperwork Reduction Act of 1995
This final order establishes special
controls that refer to previously
approved collections of information
found in other FDA regulations. 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–
3520). 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 part 801,
regarding labeling have been approved
under OMB control number 0910–0485.
IV. Reference
The following reference has been
placed on display in the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852,
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday, and is available
electronically at https://
www.regulations.gov.
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1. K131798: De Novo Request per 513(f)(2)
from Argo Medical Technologies, Inc.,
dated June 22, 2013.
List of Subjects in 21 CFR Part 890
Medical devices, Physical medicine
devices.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
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of Food and Drugs, 21 CFR part 890 is
amended as follows:
PART 890—PHYSICAL MEDICINE
DEVICES
1. The authority citation for 21 CFR
part 890 continues to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 371.
2. Revise § 890.3480 to read as
follows:
■
§ 890.3480 Powered lower extremity
exoskeleton.
(a) Identification. A powered lower
extremity exoskeleton is a prescription
device that is composed of an external,
powered, motorized orthosis that is
placed over a person’s paralyzed or
weakened limbs for medical purposes.
(b) Classification. Class II (special
controls). The special controls for this
device are:
(1) Elements of the device materials
that may contact the patient must be
demonstrated to be biocompatible.
(2) Appropriate analysis/testing must
validate electromagnetic compatibility/
interference (EMC/EMI), electrical
safety, thermal safety, mechanical
safety, battery performance and safety,
and wireless performance, if applicable.
(3) Appropriate software verification,
validation, and hazard analysis must be
performed.
(4) Design characteristics must ensure
geometry and materials composition are
consistent with intended use.
(5) Non-clinical performance testing
must demonstrate that the device
performs as intended under anticipated
conditions of use. Performance testing
must include:
(i) Mechanical bench testing
(including durability testing) to
demonstrate that the device will
withstand forces, conditions, and
environments encountered during use;
(ii) Simulated use testing (i.e., cyclic
loading testing) to demonstrate
performance of device commands and
safeguard under worst case conditions
and after durability testing;
(iii) Verification and validation of
manual override controls are necessary,
if present;
(iv) The accuracy of device features
and safeguards; and
(v) Device functionality in terms of
flame retardant materials, liquid/
particle ingress prevention, sensor and
actuator performance, and motor
performance.
(6) Clinical testing must demonstrate
a reasonable assurance of safe and
effective use and capture any adverse
events observed during clinical use
when used under the proposed
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25229
conditions of use, which must include
considerations for:
(i) Level of supervision necessary, and
(ii) Environment of use (e.g., indoors
and/or outdoors) including obstacles
and terrain representative of the
intended use environment.
(7) A training program must be
included with sufficient educational
elements so that upon completion of
training program, the clinician, user,
and companion can:
(i) Identify the safe environments for
device use,
(ii) Use all safety features of device,
and
(iii) Operate the device in simulated
or actual use environments
representative of indicated
environments and use.
(8) Labeling for the Physician and
User must include the following:
(i) Appropriate instructions, warning,
cautions, limitations, and information
related to the necessary safeguards of
the device, including warning against
activities and environments that may
put the user at greater risk.
(ii) Specific instructions and the
clinical training needed for the safe use
of the device, which includes:
(A) Instructions on assembling the
device in all available configurations;
(B) Instructions on fitting the patient;
(C) Instructions and explanations of
all available programs and how to
program the device;
(D) Instructions and explanation of all
controls, input, and outputs;
(E) Instructions on all available modes
or states of the device;
(F) Instructions on all safety features
of the device; and
(G) Instructions for properly
maintaining the device.
(iii) Information on the patient
population for which the device has
been demonstrated to have a reasonable
assurance of safety and effectiveness.
(iv) Pertinent non-clinical testing
information (e.g., EMC, battery
longevity).
(v) A detailed summary of the clinical
testing including:
(A) Adverse events encountered
under use conditions,
(B) Summary of study outcomes and
endpoints, and
(C) Information pertinent to use of the
device including the conditions under
which the device was studied (e.g., level
of supervision or assistance, and
environment of use (e.g., indoors and/or
outdoors) including obstacles and
terrain).
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Federal Register / Vol. 80, No. 85 / Monday, May 4, 2015 / Rules and Regulations
Dated: April 28, 2015.
Leslie Kux,
Associate Commissioner for Policy.
PART 1—INCOME TAXES
SUPPLEMENTARY INFORMATION:
Paragraph 1. The authority citation
for part 1 continues to read in part as
follows:
Background
■
[FR Doc. 2015–10332 Filed 5–1–15; 8:45 am]
BILLING CODE 4164–01–P
Authority: 26 U.S.C. 7805 * * *
Par. 2. Section 1.6033–2 is amended
by revising paragraph (k)(4) to read as
follows:
■
DEPARTMENT OF THE TREASURY
Internal Revenue Service
§ 1.6033–2 Return by exempt
organizations (taxable years beginning after
December 31, 1969) and returns by certain
nonexempt organizations (taxable years
beginning after December 31, 1980).
26 CFR Part 1
[TD 9708]
RIN 1545–BK57; RIN 1545–BL30; RIN 1545–
BL58
Additional Requirements for Charitable
Hospitals; Community Health Needs
Assessments for Charitable;
Requirements of a Section 4959 Excise
Tax Return and Time for Filing the
Return; Correction
Internal Revenue Service (IRS),
Treasury.
ACTION: Correcting amendment.
AGENCY:
*
*
*
*
*
(k) * * *
(4) The applicability of paragraph
(a)(2)(ii)(l) of this section shall be
limited to returns filed for taxable years
ending after December 29, 2014.
Martin V. Franks,
Chief, Publications and Regulations Branch,
Legal Processing Division, Associate Chief
Counsel (Procedure and Administration).
[FR Doc. 2015–10340 Filed 5–1–15; 8:45 am]
BILLING CODE 4830–01–P
This document contains
corrections to final regulations (TD
9708) that were published in the
Federal Register on December 31, 2014
(79 FR 78954). The final regulations
provide guidance regarding the
requirements for charitable hospital
organizations added by the Patient
Protection and Affordable Care Act of
2010.
DEPARTMENT OF THE TREASURY
This correction is effective on
May 4, 2015 and applicable beginning
December 31, 2014.
FOR FURTHER INFORMATION CONTACT:
Amy F. Giuliano, Amber L. MacKenzie,
or Stephanie N. Robbins at (202) 317–
5800 (not a toll free number).
SUPPLEMENTARY INFORMATION:
Additional Requirements for Charitable
Hospitals; Community Health Needs
Assessments for Charitable;
Requirements of a Section 4959 Excise
Tax Return and Time for Filing the
Return; Correction
SUMMARY:
DATES:
Background
The final regulations (TD 9708) that
are the subject of this correction is
under section 501 of the Internal
Revenue Code.
Need for Correction
As published, the final regulations
(TD 9708) contain an error that may
prove to be misleading and is in need
of clarification.
tkelley on DSK3SPTVN1PROD with RULES
List of Subjects in 26 CFR Part 1
Income taxes, Reporting and
recordkeeping requirements.
Correction of Publication
Accordingly, 26 CFR part 1 is
corrected by making the following
correcting amendment:
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18:00 May 01, 2015
Jkt 235001
The final regulations (TD 9708) that
are the subject of this correction are
under section 501 of the Internal
Revenue Code.
Need for Correction
As published, the final regulations
(TD 9708) contain an error that may
prove to be misleading and is in need
of clarification.
Correction of Publication
Accordingly, the final regulations (TD
9708), that are the subject of FR Doc.
2014–30525, are corrected as follows:
1. On page 78996, in the preamble,
the first column, under the paragraph
heading ‘‘Effective/Applicability Dates’’,
the second line from the bottom of the
third full paragraph, the language ‘‘6033
apply to returns filed on or after’’ is
corrected to read ‘‘6033 apply to returns
filed for taxable years ending after’’.
Martin V. Franks,
Chief, Publications and Regulations Branch,
Legal Processing Division, Associate Chief
Counsel, (Procedure and Administration).
[FR Doc. 2015–10341 Filed 5–1–15; 8:45 am]
Internal Revenue Service
BILLING CODE 4830–01–P
26 CFR Parts 1, 53, and 602
[TD 9708]
DEPARTMENT OF DEFENSE
RIN 1545–BK57; RIN 1545–BL30; RIN
1545–BL58
Office of the Secretary
32 CFR Part 320
Internal Revenue Service (IRS),
Treasury.
ACTION: Final regulations and removal of
temporary regulations; correction.
AGENCY:
This document contains
corrections to final regulations (TD
9708) that were published in the
Federal Register on December 31, 2014
(79 FR 78954). The final regulations
provide guidance regarding the
requirements for charitable hospital
organizations added by the Patient
Protection and Affordable Care Act of
2010.
SUMMARY:
This correction is effective on
May 4, 2015 and applicable beginning
December 31, 2014.
FOR FURTHER INFORMATION CONTACT:
Amy F. Giuliano, Amber L. MacKenzie,
or Stephanie N. Robbins at (202) 317–
5800 (not a toll free number).
DATES:
PO 00000
Frm 00022
Fmt 4700
Sfmt 4700
[Docket ID: DoD–2014–OS–0068]
Privacy Act; Implementation
National GeospatialIntelligence Agency (NGA), DoD.
ACTION: Direct final rule with request for
comments.
AGENCY:
National GeospatialIntelligence Agency (NGA) is updating
the NGA Privacy Act Program by adding
the (k)(2) and (k)(5) exemptions to
accurately describe the basis for
exempting the records in the system of
records notice NGA–010, National
Geospatial-Intelligence Agency Security
Financial Disclosure Reporting Records
System. In this rulemaking, the NGA
proposes to exempt portions of this
system of records from one or more
provisions of the Privacy Act because of
criminal, civil and administrative
enforcement requirements.
DATES: The rule will be effective on July
13, 2015 unless adverse comments are
received by July 6, 2015. If adverse
comment is received, the Department of
Defense will publish a timely
SUMMARY:
E:\FR\FM\04MYR1.SGM
04MYR1
]]>Agencies
[Federal Register Volume 80, Number 85 (Monday, May 4, 2015)]
[Rules and Regulations]
[Pages 25226-25230]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-10332]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 890
[Docket No. FDA-2014-N-1903]
Medical Devices; Physical Medicine Devices; Classification of the
Powered Lower Extremity Exoskeleton; Republication
AGENCY: Food and Drug Administration, HHS.
ACTION: Final order; republication.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) is
republishing in its entirety a final order entitled ``Medical Devices;
Physical Medicine Devices; Classification of the Powered Lower
Extremity Exoskeleton'' that published in the Federal Register on
February 24, 2015. FDA is republishing to correct an inadvertent
omission of information. FDA is classifying the powered lower extremity
exoskeleton into class II (special controls). The special controls that
will apply to the device are identified in this order and will be part
of the codified language for the powered lower extremity exoskeleton's
classification. The Agency is classifying the device
[[Page 25227]]
into class II (special controls) in order to provide a reasonable
assurance of safety and effectiveness of the device.
DATES: This order is effective May 4, 2015. The classification was
applicable on June 26, 2014.
FOR FURTHER INFORMATION CONTACT: Michael Hoffmann, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 1434, Silver Spring, MD 20993-0002, 301-
796-6476, Michael.Hoffmann@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In accordance with section 513(f)(1) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were
not in commercial distribution before May 28, 1976 (the date of
enactment of the Medical Device Amendments of 1976), generally referred
to as postamendments devices, are classified automatically by statute
into class III without any FDA rulemaking process. These devices remain
in class III and require premarket approval, unless and until the
device is classified or reclassified into class I or II, or FDA issues
an order finding the device to be substantially equivalent, in
accordance with section 513(i) of the FD&C Act, to a predicate device
that does not require premarket approval. The Agency determines whether
new devices are substantially equivalent to predicate devices by means
of premarket notification procedures in section 510(k) of the FD&C Act
(21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.
Section 513(f)(2) of the FD&C Act, as amended by section 607 of the
Food and Drug Administration Safety and Innovation Act (Pub. L. 112-
144), provides two procedures by which a person may request FDA to
classify a device under the criteria set forth in section 513(a)(1).
Under the first procedure, the person submits a premarket notification
under section 510(k) of the FD&C Act for a device that has not
previously been classified and, within 30 days of receiving an order
classifying the device into class III under section 513(f)(1) of the
FD&C Act, the person requests a classification under section 513(f)(2).
Under the second procedure, rather than first submitting a premarket
notification under section 510(k) of the FD&C Act and then a request
for classification under the first procedure, the person determines
that there is no legally marketed device upon which to base a
determination of substantial equivalence and requests a classification
under section 513(f)(2) of the FD&C Act. If the person submits a
request to classify the device under this second procedure, FDA may
decline to undertake the classification request if FDA identifies a
legally marketed device that could provide a reasonable basis for
review of substantial equivalence with the device or if FDA determines
that the device submitted is not of ``low-moderate risk'' or that
general controls would be inadequate to control the risks and special
controls to mitigate the risks cannot be developed.
In response to a request to classify a device under either
procedure provided by section 513(f)(2) of the FD&C Act, FDA will
classify the device by written order within 120 days. This
classification will be the initial classification of the device.
On June 22, 2013, Argo Medical Technologies, Inc., submitted a
request for classification of the ReWalk under section 513(f)(2) of the
FD&C Act. The manufacturer recommended that the device be classified
into class II (Ref. 1).
In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed
the request in order to classify the device under the criteria for
classification set forth in section 513(a)(1). FDA classifies devices
into class II if general controls by themselves are insufficient to
provide reasonable assurance of safety and effectiveness, but there is
sufficient information to establish special controls to provide
reasonable assurance of the safety and effectiveness of the device for
its intended use. After review of the information submitted in the
request, FDA determined that the device can be classified into class II
with the establishment of special controls. FDA believes these special
controls, in addition to general controls, will provide reasonable
assurance of the safety and effectiveness of the device.
Therefore, on June 26, 2014, FDA issued an order to the requestor
classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 890.3480.
Following the effective date of this final classification order,
any firm submitting a premarket notification (510(k)) for a powered
lower extremity exoskeleton will need to comply with the special
controls named in this final order. The device is assigned the generic
name powered lower extremity exoskeleton, and it is identified as a
prescription device that is composed of an external, powered, motorized
orthosis that is placed over a person's paralyzed or weakened limbs for
medical purposes.
FDA has identified the following risks to health associated
specifically with this type of device, as well as the measures required
to mitigate these risks in table 1.
Table 1--Powered Lower Extremity Exoskeleton Risks and Mitigation
Measures
------------------------------------------------------------------------
Identified risk Mitigation measure
------------------------------------------------------------------------
Instability, falls, and associated Clinical testing
injuries.
Training
Software verification,
validation, and hazard
analysis
Wireless testing
Electromagnetic compatibility
(EMC) and electromagnetic
interference (EMI) testing
Electrical safety testing
Design characteristics
Non-clinical performance
testing
Water/particle ingress testing
Durability testing
Battery testing
Labeling
Bruising, skin abrasion, pressure Clinical testing
sores, soft tissue injury.
Training
Labeling
Diastolic hypertension and changes in Clinical testing
blood pressure, and heart rate.
Training
[[Page 25228]]
Labeling
Adverse tissue reaction................ Biocompatibility assessment
Premature battery failure.............. Battery testing
Labeling
Interference with other electrical EMC/EMI testing
equipment/devices.
Labeling
Burns, electrical shock................ Electrical safety testing
Thermal testing
Labeling
Device malfunction resulting in Clinical testing
unanticipated operation (e.g., device
stoppage, unintended movement).
Non-clinical performance
testing
Training
Software verification,
validation, and hazard
analysis
Electrical safety testing
Battery testing
Water/particle ingress testing
Wireless testing
EMC/EMI testing
Flammability testing
Labeling
Use error.............................. Clinical testing
Training
Labeling
------------------------------------------------------------------------
FDA believes that the following special controls, in combination
with the general controls, address these risks to health and provide
reasonable assurance of the safety and effectiveness:
Elements of the device materials that may contact the
patient must be demonstrated to be biocompatible.
Appropriate analysis/testing must validate electronic
compatibility/interference (EMC/EMI), electrical safety, thermal
safety, mechanical safety, battery performance and safety, and wireless
performance, if applicable.
Appropriate software verification, validation, and hazard
analysis must be performed.
Design characteristics must ensure geometry and materials
composition are consistent with intended use.
Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions of use.
Performance testing must include:
[cir] Mechanical bench testing (including durability testing) to
demonstrate that the device will withstand forces, conditions, and
environments encountered during use;
[cir] simulated use testing (i.e., cyclic loading testing) to
demonstrate performance of device commands and safeguard under worst
case conditions and after durability testing;
[cir] verification and validation of manual override controls are
necessary, if present;
[cir] the accuracy of device features and safeguards; and
[cir] device functionality in terms of flame retardant materials,
liquid/particle ingress prevention, sensor and actuator performance,
and motor performance.
Clinical testing must demonstrate a reasonable assurance
of safe and effective use and capture any adverse events observed
during clinical use when used under the proposed conditions of use,
which must include considerations for:
[cir] Level of supervision necessary and
[cir] environment of use (e.g., indoors and/or outdoors), including
obstacles and terrain representative of the intended use environment.
A training program must be included with sufficient
educational elements so that upon completion of training program, the
clinician, user, and companion can:
[cir] Identify the safe environments for device use,
[cir] use all safety features of device, and
[cir] operate the device in simulated or actual use environments
representative of indicated environments and use.
Labeling for the Physician and User must include the
following:
[cir] Appropriate instructions, warning, cautions, limitations, and
information related to the necessary safeguards of the device,
including warning against activities and environments that may put the
user at greater risk;
[cir] specific instructions and the clinical training needed for
the safe use of the device, which includes:
[ssquf] Instructions on assembling the device in all available
configurations;
[ssquf] instructions on fitting the patient;
[ssquf] instructions and explanations of all available programs and
how to program the device;
[ssquf] instructions and explanation of all controls, input, and
outputs;
[ssquf] instructions on all available modes or states of the
device;
[ssquf] instructions on all safety features of the device; and
[ssquf] instructions for properly maintaining the device;
[cir] Information on the patient population for which the device
has been demonstrated to have a reasonable assurance of safety and
effectiveness;
[cir] pertinent non-clinical testing information (e.g., EMC,
battery longevity); and
[cir] a detailed summary of the clinical testing including:
[ssquf] Adverse events encountered under use conditions,
[ssquf] summary of study outcomes and endpoints, and
[ssquf] information pertinent to use of the device including the
conditions under which the device was studied (e.g., level of
supervision or assistance, and environment of use (e.g., indoors and/or
outdoors) including obstacles and terrain).
Powered lower extremity exoskeleton devices are restricted to
patient use only upon the authorization of a practitioner licensed by
law to administer or use the device; see 21 CFR 801.109 (Prescription
devices).
Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification
[[Page 25229]]
requirements under section 510(k) of the FD&C Act if FDA determines
that premarket notification is not necessary to provide reasonable
assurance of the safety and effectiveness of the device. For this type
of device, FDA has determined that premarket notification is necessary
to provide reasonable assurance of the safety and effectiveness of the
device. Therefore, this device type is not exempt from premarket
notification requirements. Persons who intend to market this type of
device must submit to FDA a premarket notification, prior to marketing
the device, which contains information about the powered lower
extremity exoskeleton they intend to market.
II. Environmental Impact
The Agency has determined under 21 CFR 25.34(b) 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.
III. Paperwork Reduction Act of 1995
This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations. 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. 3501-3520). 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 part 801, regarding labeling have been
approved under OMB control number 0910-0485.
IV. Reference
The following reference has been placed on display in the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and is available electronically at https://www.regulations.gov.
1. K131798: De Novo Request per 513(f)(2) from Argo Medical
Technologies, Inc., dated June 22, 2013.
List of Subjects in 21 CFR Part 890
Medical devices, Physical medicine 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 21 CFR part 890 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
0
2. Revise Sec. 890.3480 to read as follows:
Sec. 890.3480 Powered lower extremity exoskeleton.
(a) Identification. A powered lower extremity exoskeleton is a
prescription device that is composed of an external, powered, motorized
orthosis that is placed over a person's paralyzed or weakened limbs for
medical purposes.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Elements of the device materials that may contact the patient
must be demonstrated to be biocompatible.
(2) Appropriate analysis/testing must validate electromagnetic
compatibility/interference (EMC/EMI), electrical safety, thermal
safety, mechanical safety, battery performance and safety, and wireless
performance, if applicable.
(3) Appropriate software verification, validation, and hazard
analysis must be performed.
(4) Design characteristics must ensure geometry and materials
composition are consistent with intended use.
(5) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions of use.
Performance testing must include:
(i) Mechanical bench testing (including durability testing) to
demonstrate that the device will withstand forces, conditions, and
environments encountered during use;
(ii) Simulated use testing (i.e., cyclic loading testing) to
demonstrate performance of device commands and safeguard under worst
case conditions and after durability testing;
(iii) Verification and validation of manual override controls are
necessary, if present;
(iv) The accuracy of device features and safeguards; and
(v) Device functionality in terms of flame retardant materials,
liquid/particle ingress prevention, sensor and actuator performance,
and motor performance.
(6) Clinical testing must demonstrate a reasonable assurance of
safe and effective use and capture any adverse events observed during
clinical use when used under the proposed conditions of use, which must
include considerations for:
(i) Level of supervision necessary, and
(ii) Environment of use (e.g., indoors and/or outdoors) including
obstacles and terrain representative of the intended use environment.
(7) A training program must be included with sufficient educational
elements so that upon completion of training program, the clinician,
user, and companion can:
(i) Identify the safe environments for device use,
(ii) Use all safety features of device, and
(iii) Operate the device in simulated or actual use environments
representative of indicated environments and use.
(8) Labeling for the Physician and User must include the following:
(i) Appropriate instructions, warning, cautions, limitations, and
information related to the necessary safeguards of the device,
including warning against activities and environments that may put the
user at greater risk.
(ii) Specific instructions and the clinical training needed for the
safe use of the device, which includes:
(A) Instructions on assembling the device in all available
configurations;
(B) Instructions on fitting the patient;
(C) Instructions and explanations of all available programs and how
to program the device;
(D) Instructions and explanation of all controls, input, and
outputs;
(E) Instructions on all available modes or states of the device;
(F) Instructions on all safety features of the device; and
(G) Instructions for properly maintaining the device.
(iii) Information on the patient population for which the device
has been demonstrated to have a reasonable assurance of safety and
effectiveness.
(iv) Pertinent non-clinical testing information (e.g., EMC, battery
longevity).
(v) A detailed summary of the clinical testing including:
(A) Adverse events encountered under use conditions,
(B) Summary of study outcomes and endpoints, and
(C) Information pertinent to use of the device including the
conditions under which the device was studied (e.g., level of
supervision or assistance, and environment of use (e.g., indoors and/or
outdoors) including obstacles and terrain).
[[Page 25230]]
Dated: April 28, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-10332 Filed 5-1-15; 8:45 am]
BILLING CODE 4164-01-P
