Physical Medicine Devices; Withdrawal of Proposed Effective Date of Requirement for Premarket Approval for Shortwave Diathermy for All Other Uses, 9670-9671 [2014-03593]
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9670
Federal Register / Vol. 79, No. 34 / Thursday, February 20, 2014 / Proposed Rules
Subpart N—[Amended]
13. The authority citation for subpart
N of part 416 continues to read as
follows:
■
Authority: Secs. 702(a)(5), 1631, and 1633
of the Social Security Act (42 U.S.C.
902(a)(5), 1383, and 1383b); sec. 202, Pub. L.
108–203, 118 Stat. 509 (42 U.S.C. 902 note).
14. Amend § 416.1400 by revising
paragraph (b) to read as follows:
■
§ 416.1400
Introduction
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*
*
(b) Nature of the administrative
review process. In making a
determination or decision in your case,
we conduct the administrative review
process in an informal, non-adversarial
manner. Subject to the limitations on
Appeals Council consideration of
additional evidence (see §§ 416.1470(b)
and 416.1476(b)), we will consider at
each step of the review process any
information you present as well as all
the information in our records. You may
present the information yourself or have
someone represent you, including an
attorney. If you are dissatisfied with our
decision in the review process, but do
not take the next step within the stated
time period, you will lose your right to
further administrative review and your
right to judicial review, unless you can
show us that there was good cause for
your failure to make a timely request for
review.
*
*
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*
■ 15. Revise § 416.1435 to read as
follows:
§ 416.1435 Submitting evidence prior to a
hearing before an administrative law judge.
You should submit information or
evidence as required by § 416.912 or any
summary of the evidence to the
administrative law judge with the
request for hearing or within 10 days
after filing the request, if possible. Each
party shall make every effort to ensure
that the administrative law judge
receives all of the evidence (see
§ 416.912) or all of the evidence is
available at the time and place set for
the hearing.
Subpart O—[Amended]
16. The authority citation for subpart
O of part 416 continues to read as
follows:
tkelley on DSK3SPTVN1PROD with PROPOSALS
■
Authority: Secs. 702(a)(5), 1127, and
1631(d) of the Social Security Act (42 U.S.C.
902(a)(5), 1320a–6, and 1383(d)).
17. In § 416.1540, revise paragraphs
(b)(1) and (b)(2)(i) through (vii) to read
as follows:
■
VerDate Mar<15>2010
17:08 Feb 19, 2014
Jkt 232001
§ 416.1540 Rules of conduct and
standards of responsibility for
representatives.
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(b) * * *
(1) Act with reasonable promptness to
help obtain the information or evidence
that the claimant must submit under our
regulations, and forward the
information or evidence to us for
consideration as soon as practicable.
(2) * * *
(i) The claimant’s medical source(s);
(ii) The claimant’s age;
(iii) The claimant’s education and
training;
(iv) The claimant’s work experience;
(v) The claimant’s daily activities both
before and after the date the claimant
alleges that he or she became disabled;
(vi) The claimant’s efforts to work;
and
(vii) Any other factors showing how
the claimant’s impairment(s) affects his
or her ability to work. In §§ 416.960
through 416.969a, we discuss in more
detail the evidence we need when we
consider vocational factors;
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[FR Doc. 2014–03426 Filed 2–19–14; 8:45 am]
BILLING CODE 4191–02–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 890
[Docket No. FDA–2012–N–0378]
Physical Medicine Devices; Withdrawal
of Proposed Effective Date of
Requirement for Premarket Approval
for Shortwave Diathermy for All Other
Uses
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Proposed rule; withdrawal.
The Food and Drug
Administration (FDA) is withdrawing
the proposed rule the Agency issued in
the Federal Register of July 6, 2012. In
that document, FDA proposed to require
the filing of a premarket approval
application (PMA) or a notice of
completion of a product development
protocol (PDP) for the class III
preamendment device, shortwave
diathermy (SWD) for all other uses. In
response to the requirements issued in
the Food and Drug Administration
Safety and Innovation Act (FDASIA)
and new information received during a
panel meeting, FDA is withdrawing the
proposed rule and proposing a different
action.
SUMMARY:
PO 00000
Frm 00028
Fmt 4702
Sfmt 4702
The proposed rule is withdrawn
on February 20, 2014.
FOR FURTHER INFORMATION CONTACT:
Melissa Burns, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1646, Silver Spring,
MD 20993, 301–796–5616, Melissa.
Burns@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
DATES:
I. Background—Regulatory Authorities
In the Federal Register of July 6, 2012
(77 FR 39953), FDA issued a proposed
rule to require the filing of a PMA or a
notice of completion of a PDP for the
class III preamendments device, SWD
for all other uses. This device applies
electromagnetic energy to the body in
the radio frequency bands that are
currently identified as 13.56 megahertz
or 27.12 megahertz and is intended for
the treatment of medical conditions by
means other than the generation of deep
heat within body tissues (also referred
to as nonthermal SWD). It is not
intended for treatment of malignancies.
The Agency also summarized its
proposed findings regarding the degree
of risk of illness or injury designed to
be eliminated or reduced by requiring
the devices to meet the statute’s
approval requirements and the benefits
to the public from the use of the
devices. In addition, FDA announced
the opportunity for interested persons to
request that the Agency change the
classification of any of the
aforementioned devices based on new
information.
On July 9, 2012, FDASIA was enacted.
Section 608(a) of FDASIA (126 Stat.
1056) amended section 513(e) (U.S.C.
360c(e)) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) changing the
process for reclassifying a device from
rulemaking to an administrative order.
Subsequent to the publication of the
proposed rule, FDASIA’s amendments
to section 513 of the FD&C Act required
FDA to hold a classification panel (an
FDA advisory committee) meeting on
the classification of this device. On May
21, 2013, FDA held a meeting of the
Orthopedic and Rehabilitation Devices
Panel (the Panel), to discuss the
classification of nonthermal SWD
devices. There was panel consensus that
although the effectiveness data were
very limited, nonthermal SWD devices
did not fit the regulatory definition of a
class III device. Coupled with the
rationale that special controls could be
established to reasonably demonstrate
an assurance of safety and effectiveness,
the Panel recommended class II (special
controls) for nonthermal SWD devices
(Ref. 1).
E:\FR\FM\20FEP1.SGM
20FEP1
Federal Register / Vol. 79, No. 34 / Thursday, February 20, 2014 / Proposed Rules
II. Withdrawal of the Proposed Rule
FDA provided an opportunity for
interested parties to comment on the
proposed rule for SWD for all other uses
(77 FR 39953, July 6, 2012). FDA
received over 240 comments to the
docket in response to the 2012 proposed
rule. Comments that expressed an
opinion about the classification of
nonthermal SWD devices were usually
in favor of a class II designation. Some
comments did not openly state an
opinion, but included arguments against
the proposed rule that could reasonably
be interpreted as support for a class II
designation. There were also comments
that agreed with a class III designation.
In addition to the comments, FDA
received five separate submissions to
request a change in the classification of
nonthermal SWD from class III to class
II. In response to these comments and
findings at the Panel meeting, FDA is
withdrawing the proposed rule to call
for PMAs for these devices and is
proposing reclassification to class II
(special controls).
III. Proposed Reclassification
Elsewhere in this issue of the Federal
Register, FDA is proposing to reclassify
SWD for all other uses, currently a
preamendments class III device, into
class II (special controls), and to rename
the device ‘‘nonthermal shortwave
therapy.’’ FDA continues to review the
merits of the submissions for requests
for reclassification that meet the
requirements under 21 CFR 860.123,
submitted in response to the proposed
rule.
IV. Reference
tkelley on DSK3SPTVN1PROD with PROPOSALS
The following reference has been
placed on display in the Division of
Dockets Management (see ADDRESSES),
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday, and are available
electronically at https://
www.regulations.gov. (FDA has verified
the Web site address, but we are not
responsible for any subsequent changes
to the Web sites after this document
publishes in the Federal Register.)
1. FDA’s Orthopedic and Rehabilitation
Devices Panel transcript and other
meeting materials are available on FDA’s
Web site at https://www.fda.gov/Advisory
Committees/CommitteesMeeting
Materials/MedicalDevices/Medical
DevicesAdvisoryCommittee/Orthopaedic
andRehabilitationDevicesPanel/
ucm352525.htm.
VerDate Mar<15>2010
17:08 Feb 19, 2014
Jkt 232001
Dated: February 13, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–03593 Filed 2–19–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 890
[Docket No. FDA–2012–N–0378]
Physical Medicine Devices;
Reclassification and Renaming of
Shortwave Diathermy for All Other
Uses
AGENCY:
Food and Drug Administration,
HHS.
Proposed order; technical
correction.
ACTION:
The Food and Drug
Administration (FDA) is proposing to
reclassify the shortwave diathermy
(SWD) for all other uses, a
preamendments class III device, into
class II (special controls), and to rename
the device ‘‘nonthermal shortwave
therapy (SWT).’’ FDA is proposing this
reclassification on its own initiative
based on new information. FDA is also
proposing a technical correction in the
regulation for the carrier frequency for
SWD and nonthermal SWT devices.
This proposed action would implement
certain regulatory requirements.
DATES: Submit either electronic or
written comments on this proposed
order by May 21, 2014. February 21,
2014FDA intends that SWD devices for
all other uses must comply with the
special controls and must submit a
premarket notification (510(k)) within
60 days after the effective date of the
final order. See Section XII for the
proposed effective date of a final order
based on this proposed order.
ADDRESSES: You may submit comments,
identified by Docket No. FDA–2012–N–
0378, by any of the following methods:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Written Submissions
Submit written submissions in the
following way:
• Mail/Hand delivery/Courier (for
paper submissions): Division of Dockets
Management (HFA–305), Food and Drug
PO 00000
Frm 00029
Fmt 4702
Sfmt 4702
9671
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Instructions: All submissions received
must include the Agency name and
Docket No. FDA–2012–N–0378 for this
rulemaking. All comments received may
be posted without change to https://
www.regulations.gov, including any
personal information provided. For
additional information on submitting
comments, see the ‘‘Comments’’ heading
of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Melissa Burns, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1646, Silver Spring,
MD 20993, 301–796–5616,
Melissa.Burns@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background—Regulatory Authorities
The Federal Food, Drug, and Cosmetic
Act (FD&C Act), as amended by the
Medical Device Amendments of 1976
(the 1976 amendments) (Pub. L. 94–
295), the Safe Medical Devices Act of
1990 (Pub. L. 101–629), the Food and
Drug Administration Modernization Act
of 1997 (Pub. L. 105–115), the Medical
Device User Fee and Modernization Act
of 2002 (Pub. L. 107–250), the Medical
Devices Technical Corrections Act of
2004 (Pub. L. 108–214), the Food and
Drug Administration Amendments Act
of 2007 (Pub. L. 110–85), and the Food
and Drug Administration Safety and
Innovation Act (FDASIA) (Pub. L. 112–
144) established a comprehensive
system for the regulation of medical
devices intended for human use.
Section 513 of the FD&C Act (21 U.S.C.
360c) established three categories
(classes) of devices, reflecting the
regulatory controls needed to provide
reasonable assurance of their safety and
effectiveness. The three categories of
devices are class I (general controls),
class II (special controls), and class III
(premarket approval).
Section 513(a)(1) of the FD&C Act
defines class II devices as those devices
for which the general controls by
themselves are insufficient to provide
reasonable assurance of safety and
effectiveness, but for which there is
sufficient information to establish
E:\FR\FM\20FEP1.SGM
20FEP1
]]>Agencies
[Federal Register Volume 79, Number 34 (Thursday, February 20, 2014)]
[Proposed Rules]
[Pages 9670-9671]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-03593]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 890
[Docket No. FDA-2012-N-0378]
Physical Medicine Devices; Withdrawal of Proposed Effective Date
of Requirement for Premarket Approval for Shortwave Diathermy for All
Other Uses
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule; withdrawal.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing the
proposed rule the Agency issued in the Federal Register of July 6,
2012. In that document, FDA proposed to require the filing of a
premarket approval application (PMA) or a notice of completion of a
product development protocol (PDP) for the class III preamendment
device, shortwave diathermy (SWD) for all other uses. In response to
the requirements issued in the Food and Drug Administration Safety and
Innovation Act (FDASIA) and new information received during a panel
meeting, FDA is withdrawing the proposed rule and proposing a different
action.
DATES: The proposed rule is withdrawn on February 20, 2014.
FOR FURTHER INFORMATION CONTACT: Melissa Burns, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1646, Silver Spring, MD 20993, 301-796-5616,
Melissa.Burns@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background--Regulatory Authorities
In the Federal Register of July 6, 2012 (77 FR 39953), FDA issued a
proposed rule to require the filing of a PMA or a notice of completion
of a PDP for the class III preamendments device, SWD for all other
uses. This device applies electromagnetic energy to the body in the
radio frequency bands that are currently identified as 13.56 megahertz
or 27.12 megahertz and is intended for the treatment of medical
conditions by means other than the generation of deep heat within body
tissues (also referred to as nonthermal SWD). It is not intended for
treatment of malignancies. The Agency also summarized its proposed
findings regarding the degree of risk of illness or injury designed to
be eliminated or reduced by requiring the devices to meet the statute's
approval requirements and the benefits to the public from the use of
the devices. In addition, FDA announced the opportunity for interested
persons to request that the Agency change the classification of any of
the aforementioned devices based on new information.
On July 9, 2012, FDASIA was enacted. Section 608(a) of FDASIA (126
Stat. 1056) amended section 513(e) (U.S.C. 360c(e)) of the Federal
Food, Drug, and Cosmetic Act (FD&C Act) changing the process for
reclassifying a device from rulemaking to an administrative order.
Subsequent to the publication of the proposed rule, FDASIA's amendments
to section 513 of the FD&C Act required FDA to hold a classification
panel (an FDA advisory committee) meeting on the classification of this
device. On May 21, 2013, FDA held a meeting of the Orthopedic and
Rehabilitation Devices Panel (the Panel), to discuss the classification
of nonthermal SWD devices. There was panel consensus that although the
effectiveness data were very limited, nonthermal SWD devices did not
fit the regulatory definition of a class III device. Coupled with the
rationale that special controls could be established to reasonably
demonstrate an assurance of safety and effectiveness, the Panel
recommended class II (special controls) for nonthermal SWD devices
(Ref. 1).
[[Page 9671]]
II. Withdrawal of the Proposed Rule
FDA provided an opportunity for interested parties to comment on
the proposed rule for SWD for all other uses (77 FR 39953, July 6,
2012). FDA received over 240 comments to the docket in response to the
2012 proposed rule. Comments that expressed an opinion about the
classification of nonthermal SWD devices were usually in favor of a
class II designation. Some comments did not openly state an opinion,
but included arguments against the proposed rule that could reasonably
be interpreted as support for a class II designation. There were also
comments that agreed with a class III designation. In addition to the
comments, FDA received five separate submissions to request a change in
the classification of nonthermal SWD from class III to class II. In
response to these comments and findings at the Panel meeting, FDA is
withdrawing the proposed rule to call for PMAs for these devices and is
proposing reclassification to class II (special controls).
III. Proposed Reclassification
Elsewhere in this issue of the Federal Register, FDA is proposing
to reclassify SWD for all other uses, currently a preamendments class
III device, into class II (special controls), and to rename the device
``nonthermal shortwave therapy.'' FDA continues to review the merits of
the submissions for requests for reclassification that meet the
requirements under 21 CFR 860.123, submitted in response to the
proposed rule.
IV. Reference
The following reference has been placed on display in the Division
of Dockets Management (see ADDRESSES), and may be seen by interested
persons between 9 a.m. and 4 p.m., Monday through Friday, and are
available electronically at https://www.regulations.gov. (FDA has
verified the Web site address, but we are not responsible for any
subsequent changes to the Web sites after this document publishes in
the Federal Register.)
1. FDA's Orthopedic and Rehabilitation Devices Panel transcript and
other meeting materials are available on FDA's Web site at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/ucm352525.htm.
Dated: February 13, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03593 Filed 2-19-14; 8:45 am]
BILLING CODE 4160-01-P
