80 FR 25226 - Medical Devices; Physical Medicine Devices; Classification of the Powered Lower Extremity Exoskeleton; Republication

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 85 (May 4, 2015)

Page Range		25226-25230
FR Document		2015-10332
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 into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Federal Register, Volume 80 Issue 85 (Monday, May 4, 2015)
[Federal Register Volume 80, Number 85 (Monday, May 4, 2015)]
[Rules and Regulations]
[Pages 25226-25230]
From the Federal Register Online  [www.thefederalregister.org]
[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, [email protected].

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 http://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
Federal Register / Vol. 80, No. 85 / Monday, May 4, 2015 / Rules and Regulations 25227

into class II (special controls) in order person may request FDA to classify a manufacturer recommended that the
to provide a reasonable assurance of device under the criteria set forth in device be classified into class II (Ref. 1).
safety and effectiveness of the device. section 513(a)(1). Under the first In accordance with section 513(f)(2) of
DATES: This order is effective May 4, procedure, the person submits a the FD&C Act, FDA reviewed the
2015. The classification was applicable premarket notification under section request in order to classify the device
on June 26, 2014. 510(k) of the FD&C Act for a device that under the criteria for classification set
FOR FURTHER INFORMATION CONTACT: has not previously been classified and, forth in section 513(a)(1). FDA classifies
Michael Hoffmann, Center for Devices within 30 days of receiving an order devices into class II if general controls
and Radiological Health, Food and Drug classifying the device into class III by themselves are insufficient to
Administration, 10903 New Hampshire under section 513(f)(1) of the FD&C Act, provide reasonable assurance of safety
Ave., Bldg. 66, rm. 1434, Silver Spring, the person requests a classification and effectiveness, but there is sufficient
MD 20993–0002, 301–796–6476, under section 513(f)(2). Under the information to establish special controls
Michael.Hoffmann@fda.hhs.gov. second procedure, rather than first to provide reasonable assurance of the
SUPPLEMENTARY INFORMATION: submitting a premarket notification safety and effectiveness of the device for
under section 510(k) of the FD&C Act its intended use. After review of the
I. Background and then a request for classification information submitted in the request,
In accordance with section 513(f)(1) of under the first procedure, the person FDA determined that the device can be
the Federal Food, Drug, and Cosmetic determines that there is no legally classified into class II with the
Act (the FD&C Act) (21 U.S.C. marketed device upon which to base a establishment of special controls. FDA
360c(f)(1)), devices that were not in determination of substantial believes these special controls, in
commercial distribution before May 28, equivalence and requests a classification addition to general controls, will
1976 (the date of enactment of the under section 513(f)(2) of the FD&C Act. provide reasonable assurance of the
Medical Device Amendments of 1976), If the person submits a request to safety and effectiveness of the device.
generally referred to as postamendments classify the device under this second Therefore, on June 26, 2014, FDA
devices, are classified automatically by procedure, FDA may decline to issued an order to the requestor
statute into class III without any FDA undertake the classification request if classifying the device into class II. FDA
rulemaking process. These devices FDA identifies a legally marketed device is codifying the classification of the
remain in class III and require that could provide a reasonable basis for device by adding 21 CFR 890.3480.
premarket approval, unless and until review of substantial equivalence with Following the effective date of this
the device is classified or reclassified the device or if FDA determines that the final classification order, any firm
into class I or II, or FDA issues an order device submitted is not of ‘‘low- submitting a premarket notification
finding the device to be substantially moderate risk’’ or that general controls (510(k)) for a powered lower extremity
equivalent, in accordance with section would be inadequate to control the risks exoskeleton will need to comply with
513(i) of the FD&C Act, to a predicate and special controls to mitigate the risks the special controls named in this final
device that does not require premarket cannot be developed. order. The device is assigned the generic
approval. The Agency determines name powered lower extremity
In response to a request to classify a exoskeleton, and it is identified as a
whether new devices are substantially
device under either procedure provided prescription device that is composed of
equivalent to predicate devices by
by section 513(f)(2) of the FD&C Act, an external, powered, motorized
means of premarket notification
FDA will classify the device by written orthosis that is placed over a person’s
procedures in section 510(k) of the
order within 120 days. This paralyzed or weakened limbs for
FD&C Act (21 U.S.C. 360(k)) and part
807 (21 CFR part 807) of the regulations. classification will be the initial medical purposes.
Section 513(f)(2) of the FD&C Act, as classification of the device. FDA has identified the following risks
amended by section 607 of the Food and On June 22, 2013, Argo Medical to health associated specifically with
Drug Administration Safety and Technologies, Inc., submitted a request this type of device, as well as the
Innovation Act (Pub. L. 112–144), for classification of the ReWalk under measures required to mitigate these
provides two procedures by which a section 513(f)(2) of the FD&C Act. The risks in table 1.

TABLE 1—POWERED LOWER EXTREMITY EXOSKELETON RISKS AND MITIGATION MEASURES
Identified risk Mitigation measure

Instability, falls, and associated injuries ................................................... 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
tkelley on DSK3SPTVN1PROD with RULES

Battery testing
Labeling
Bruising, skin abrasion, pressure sores, soft tissue injury ....................... Clinical testing
Training
Labeling
Diastolic hypertension and changes in blood pressure, and heart rate .. Clinical testing
Training

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25230 Federal Register / Vol. 80, No. 85 / Monday, May 4, 2015 / Rules and Regulations

Dated: April 28, 2015. PART 1—INCOME TAXES SUPPLEMENTARY INFORMATION:
Leslie Kux,
■ Paragraph 1. The authority citation Background
Associate Commissioner for Policy.
[FR Doc. 2015–10332 Filed 5–1–15; 8:45 am] for part 1 continues to read in part as The final regulations (TD 9708) that
BILLING CODE 4164–01–P
follows: are the subject of this correction are
Authority: 26 U.S.C. 7805 * * * under section 501 of the Internal
Revenue Code.
■ Par. 2. Section 1.6033–2 is amended
by revising paragraph (k)(4) to read as Need for Correction
DEPARTMENT OF THE TREASURY
follows: As published, the final regulations
Internal Revenue Service § 1.6033–2 Return by exempt (TD 9708) contain an error that may
organizations (taxable years beginning after prove to be misleading and is in need
26 CFR Part 1 December 31, 1969) and returns by certain of clarification.
nonexempt organizations (taxable years
[TD 9708] beginning after December 31, 1980). Correction of Publication
* * * * * Accordingly, the final regulations (TD
RIN 1545–BK57; RIN 1545–BL30; RIN 1545– (k) * * * 9708), that are the subject of FR Doc.
BL58 (4) The applicability of paragraph 2014–30525, are corrected as follows:
(a)(2)(ii)(l) of this section shall be 1. On page 78996, in the preamble,
Additional Requirements for Charitable the first column, under the paragraph
limited to returns filed for taxable years
Hospitals; Community Health Needs heading ‘‘Effective/Applicability Dates’’,
ending after December 29, 2014.
Assessments for Charitable; the second line from the bottom of the
Requirements of a Section 4959 Excise Martin V. Franks,
third full paragraph, the language ‘‘6033
Tax Return and Time for Filing the Chief, Publications and Regulations Branch, apply to returns filed on or after’’ is
Return; Correction Legal Processing Division, Associate Chief
corrected to read ‘‘6033 apply to returns
Counsel (Procedure and Administration).
AGENCY: Internal Revenue Service (IRS), filed for taxable years ending after’’.
[FR Doc. 2015–10340 Filed 5–1–15; 8:45 am]
Treasury. Martin V. Franks,
BILLING CODE 4830–01–P
ACTION: Correcting amendment. Chief, Publications and Regulations Branch,
Legal Processing Division, Associate Chief
SUMMARY: This document contains DEPARTMENT OF THE TREASURY Counsel, (Procedure and Administration).
corrections to final regulations (TD [FR Doc. 2015–10341 Filed 5–1–15; 8:45 am]
9708) that were published in the Internal Revenue Service BILLING CODE 4830–01–P
Federal Register on December 31, 2014
(79 FR 78954). The final regulations 26 CFR Parts 1, 53, and 602
provide guidance regarding the
requirements for charitable hospital [TD 9708] DEPARTMENT OF DEFENSE
organizations added by the Patient Office of the Secretary
RIN 1545–BK57; RIN 1545–BL30; RIN
Protection and Affordable Care Act of
1545–BL58
2010. 32 CFR Part 320
DATES: This correction is effective on Additional Requirements for Charitable
Hospitals; Community Health Needs [Docket ID: DoD–2014–OS–0068]
May 4, 2015 and applicable beginning
December 31, 2014. Assessments for Charitable; Privacy Act; Implementation
FOR FURTHER INFORMATION CONTACT: Requirements of a Section 4959 Excise
Amy F. Giuliano, Amber L. MacKenzie, Tax Return and Time for Filing the AGENCY: National Geospatial-
or Stephanie N. Robbins at (202) 317– Return; Correction Intelligence Agency (NGA), DoD.
5800 (not a toll free number). ACTION: Direct final rule with request for
AGENCY: Internal Revenue Service (IRS),
SUPPLEMENTARY INFORMATION: Treasury. comments.

Background ACTION: Final regulations and removal of SUMMARY: National Geospatial-
temporary regulations; correction. Intelligence Agency (NGA) is updating
The final regulations (TD 9708) that
the NGA Privacy Act Program by adding
are the subject of this correction is SUMMARY: This document contains the (k)(2) and (k)(5) exemptions to
under section 501 of the Internal corrections to final regulations (TD accurately describe the basis for
Revenue Code. 9708) that were published in the exempting the records in the system of
Need for Correction Federal Register on December 31, 2014 records notice NGA–010, National
(79 FR 78954). The final regulations Geospatial-Intelligence Agency Security
As published, the final regulations provide guidance regarding the
(TD 9708) contain an error that may Financial Disclosure Reporting Records
requirements for charitable hospital System. In this rulemaking, the NGA
prove to be misleading and is in need organizations added by the Patient
of clarification. proposes to exempt portions of this
Protection and Affordable Care Act of system of records from one or more
List of Subjects in 26 CFR Part 1 2010. provisions of the Privacy Act because of
Income taxes, Reporting and DATES: This correction is effective on criminal, civil and administrative
tkelley on DSK3SPTVN1PROD with RULES

recordkeeping requirements. May 4, 2015 and applicable beginning enforcement requirements.
December 31, 2014. DATES: The rule will be effective on July
Correction of Publication FOR FURTHER INFORMATION CONTACT: 13, 2015 unless adverse comments are
Accordingly, 26 CFR part 1 is Amy F. Giuliano, Amber L. MacKenzie, received by July 6, 2015. If adverse
corrected by making the following or Stephanie N. Robbins at (202) 317– comment is received, the Department of
correcting amendment: 5800 (not a toll free number). Defense will publish a timely

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Document Created: 2018-02-21 10:22:59
Document Modified: 2018-02-21 10:22:59
Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final order; republication.
Dates		This order is effective May 4, 2015. The classification was applicable on June 26, 2014.
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, [email protected]
FR Citation		80 FR 25226
CFR Associated		Medical Devices and Physical Medicine Devices
80 FR 25226 - Medical Devices; Physical Medicine Devices; Classification of the Powered Lower Extremity Exoskeleton; Republication

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 85 (May 4, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
