Orthopedic Devices; Reclassification of Non-Invasive Bone Growth Stimulator, 1951-1954 [E7-476]
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Federal Register / Vol. 72, No. 10 / Wednesday, January 17, 2007 / Proposed Rules
engines installed on the same airplane at the
same time, if at all possible.
Alternative Methods of Compliance
(i) The Manager, Engine Certification
Office, FAA, has the authority to approve
alternative methods of compliance for this
AD if requested using the procedures found
in 14 CFR 39.19.
Related Information
(j) GE Service Bulletin No. CF34–10E S/B
73–0013, dated December 15, 2006, pertains
to the subject of this AD.
(k) Contact Tara Fitzgerald, Aerospace
Engineer, Engine Certification Office, FAA,
Engine and Propeller Directorate, 12 New
England Executive Park, Burlington, MA
01803; telephone (781) 238–7138, fax (781)
238–7199; e-mail: tara.fitzgerald@faa.gov for
more information about this AD.
Issued in Burlington, Massachusetts, on
January 10, 2007.
Francis A. Favara,
Manager, Engine and Propeller Directorate,
Aircraft Certification Service.
[FR Doc. E7–498 Filed 1–16–07; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 888
[Docket No. 2005P–0121]
Orthopedic Devices; Reclassification
of Non-Invasive Bone Growth
Stimulator
AGENCY:
Food and Drug Administration,
HHS.
Notice of panel
recommendation.
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ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is issuing for
public comment the recommendation of
the Orthopaedic and Rehabilitation
Devices Panel to deny a petition to
reclassify the non-invasive bone growth
stimulator from class III to class II. The
Panel made this recommendation after
reviewing the reclassification petition
submitted by RS Medical Corp., as well
as consideration of presentations made
at the Panel meeting by the petitioner,
FDA, and members of the public. FDA
is also issuing for public comment its
findings on the Panel’s
recommendation. After considering any
public comments on the Panel’s
recommendation and FDA’s findings,
FDA will approve or deny the
reclassification petition by order in the
form of a letter to the petitioner. FDA’s
decision on the reclassification petition
will be announced in the Federal
Register.
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Submit written or electronic
comments by April 17, 2007.
ADDRESSES: You may submit comments,
identified by Docket No. 2005P–0121,
by any of the following methods:
Electronic Submissions
Submit electronic comments in the
following ways:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Agency Web site: https://
www.fda.gov/dockets/ecomments.
Follow the instructions for submitting
comments on the agency Web site.
Written Submissions
Submit written submissions in the
following ways:
• FAX: 301–827–6870.
• Mail/Hand delivery/Courier [For
paper, disk, or CD–ROM submissions]:
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
To ensure more timely processing of
comments, FDA is no longer accepting
comments submitted to the agency by email. FDA encourages you to continue
to submit electronic comments by using
the Federal eRulemaking Portal or the
agency Web site, as described in the
Electronic Submissions portion of this
paragraph.
Instructions: All submissions received
must include the agency name and
Docket No. 2005P–0121 for this notice.
All comments received may be posted
without change to https://www.fda.gov/
ohrms/dockets/default.htm, 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.fda.gov/ohrms/dockets/
default.htm and insert the docket
number(s), 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:
Michel Janda, Center for Devices and
Radiological Health (HFZ–410), Food
and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,
240–276–3600.
SUPPLEMENTARY INFORMATION:
DATES:
I. Background (Regulatory Authorities)
The Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 301 et. seq.), as
amended by the Medical Device
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1951
Amendments of 1976 (the 1976
amendments) (Public Law 94–295), the
Safe Medical Devices Act of 1990 (the
SMDA) (Public Law 101–629), and the
Food and Drug Administration
Modernization Act of 1997 (FDAMA)
(Public Law 105–115), established a
comprehensive system for the regulation
of medical devices intended for human
use. Section 513 of the act (21 U.S.C.
360c) established three categories
(classes) of devices, depending on 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).
Under section 513 of the act, devices
that were in commercial distribution
before May 28, 1976 (the date of
enactment of the 1976 amendments),
generally referred to as preamendments
devices, are classified after FDA has: (1)
Received a recommendation from a
device classification panel (an FDA
advisory committee); (2) published the
panel’s recommendation for comment,
along with a proposed regulation
classifying the device; and (3) published
a final regulation classifying the device.
FDA has classified most
preamendments devices under these
procedures.
Devices that were not in commercial
distribution prior to May 28, 1976,
generally referred to as postamendments
devices, are classified automatically by
statute (section 513(f) of the act into
class III without any FDA rulemaking
process. Those devices remain in class
III and require premarket approval,
unless and until the device is
reclassified into class I or II or FDA
issues an order finding the device to be
substantially equivalent, under section
513(i) of the 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 act
(21 U.S.C. 360(k)) and part 807 of the
regulations (21 CFR part 807).
Reclassification of classified
postamendments devices is governed by
section 513(f)(3) of the act. This section
provides that FDA may initiate the
reclassification of a device classified
into class III under section 513(f)(1) of
the act, or the manufacturer or importer
of a device may petition the Secretary of
Health and Human Services (the
Secretary) for the issuance of an order
classifying the device in class I or class
II. FDA’s regulations in 21 CFR 860.134
set forth the procedures for the filing
and review of a petition for
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Federal Register / Vol. 72, No. 10 / Wednesday, January 17, 2007 / Proposed Rules
reclassification of such class III devices.
In order to change the classification of
the device, it is necessary that the
proposed new class have sufficient
regulatory controls to provide
reasonable assurance of the safety and
effectiveness of the device for its
intended use.
Under section 513(f)(3)(B)(i) of the
act, the Secretary may, for good cause
shown, refer a petition to a device
classification panel. The Panel shall
make a recommendation to the
Secretary respecting approval or denial
of the petition. Any such
recommendation shall contain (1) A
summary of the reasons for the
recommendation, (2) a summary of the
data upon which the recommendation is
based, and (3) an identification of the
risks to health (if any) presented by the
device with respect to which the
petition was filed.
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II. Regulatory History of the Device
In accordance with section 513(f)(1) of
the act, the non-invasive bone growth
stimulators were automatically
classified into class III because they
were not introduced or delivered for
introduction into interstate commerce
for commercial distribution before May
28, 1976, and have not been found
substantially equivalent to a device
placed in commercial distribution after
May 28, 1976, which was subsequently
classified or reclassified into class II or
class I. Therefore, the device can not be
placed in commercial distribution
unless it is reclassified under section
513(f)(3), or subject to an approved
premarket approval application (PMA)
under section 515 of the act (21 U.S.C.
360e).
In a petition dated February 7, 2005,
that was received by FDA on February
9, 2005, RS Medical Corp. requested
that FDA reclassify the non-invasive
bone growth stimulator from class III to
class II. (Ref. 1) The petition was
submitted under section 513(e) of the
act but FDA is reviewing the petition
under section 513(f)(3) of the act
because that section contains the
appropriate procedures for
reclassification of postamendments
devices. FDA requested additional
information and the petitioner amended
the petition on August 1, 2005. In
accordance with the act and the
regulations, FDA referred the petition as
amended to an FDA Advisory
Committee, the Orthopedic and
Rehabilitation Devices Panel (the Panel)
for its recommendations on the
requested reclassification.
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III. Description of Device Proposed for
Reclassification
The Petitioner identified the device as
follows:
A non-invasive bone growth
stimulator is a device that provides
stimulation through electrical and/or
magnetic fields to facilitate the healing
of nonunion fractures and lumbar spinal
fusions. The stimulation may be
delivered through capacitive coupling
(CC) with electrodes placed directly
over the treatment site or through
pulsed electromagnetic fields (PEMF)
with treatment coils placed into a brace
or over a cast at the treatment site. The
device is intended for use: (1) For the
treatment of established nonunion
fractures acquired secondary to trauma
(excluding vertebrae and flat bone), and
(2) as an adjunct to the treatment of
lumbar spinal fusion surgery for one or
two levels. The device consists of an
output waveform generator, either
battery-powered or AC-powered; a user
interface with visual and/or audible
alarms; and electrodes or coils to deliver
the stimulation.
IV. Recommendations of the Panel
On June 2, 2006, the Panel deliberated
on information in RS Medical’s petition;
the presentations made by RS Medical,
FDA, and members of the public; and
their own experience with non-invasive
bone growth stimulators (Ref. 2). The
Panel voted four to two to recommend
that non-invasive bone growth
stimulators be retained in class III.
V. Risks to Health
The Panel identified the following
risks to health associated with the noninvasive bone growth stimulator:
A. Electric Shock
A patient or health care professional
could be shocked from the use and
operation of the device via an AC line
voltage exposure during charging,
circuitry malfunction, connection/
disconnection of electrodes or coils,
control circuit failure, damaged channel
jacks, defective electrodes/coil
delivering inappropriate output, faulty
lead wires, inappropriate output, poor
connection between electrodes/coils
and lead wires, poor solder on circuit
board, reposition of electrodes/coils
during treatment, and use of AC current
source during treatment.
B. Burn
A patient or health care professional
could be burned from the use and
operation of the device via an AC line
voltage exposure during charging,
connection/disconnection of the
electrodes/coils or control unit while
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receiving treatment, defective
electrodes/coil delivering inappropriate
output, incorrect electrode/coil size or
alteration, inappropriate output, use of
AC current source for treatment, and use
of control unit and battery charger while
sleeping.
C. Skin Irritation and/or Allergic
Reaction
A patient could experience skin
irritation and/or allergic reaction
associated with the use and operation of
the device via the use of nonbiocompatible device materials and/or
non-biocompatible electrode gel.
D. Inconsistent or Ineffective Treatment
A patient could receive inconsistent
or ineffective treatment via battery
deterioration, control circuit failure,
defective electrode/coils, device damage
from dropping or bumping, device short
circuits, driver circuit failure,
electromagnetic interference (EMI) or
radio frequency interference (RFI),
failure to follow prescribed use,
hardware failure, improper position of
electrodes/coil, inappropriate output,
incorrect battery/battery charger,
ineffective output, low battery voltage,
poor interface between electrodes/coil
and patient, and switch failure.
E. Adverse Interaction with Electrical
Implants
A patient with electrically-powered
implants (such as cardiac pacemakers,
cardiac defibrillators, and neurostimulators) could experience an
adverse interaction with an implanted
electrical device via EMI or RFI.
F. Internal/External Fixation Devices
A patient with internal or external
fixation devices could receive
inconsistent or ineffective treatment due
to interaction of the device with the
metallic fixation devices via
interference with treatment field
through magnetic field interaction and/
or electrical inductance within metallic
device.
G. Biological Risks: Carcinogenicity,
Genotoxicity, Mutagenicity, and
Teratology
A patient may experience adverse
biologic affects resulting from prolonged
exposure to the treatment signal via
biologic interaction with the treatment
signal at a cellular level.
VI. Summary of Reasons for
Recommendation
The Panel believes that the noninvasive bone growth stimulator should
be retained in class III because there is
insufficient information in this petition
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Federal Register / Vol. 72, No. 10 / Wednesday, January 17, 2007 / Proposed Rules
to establish that special controls in
association with general controls would
provide a reasonable assurance of the
safety and effectiveness of the device.
VII. Summary of Data Upon Which the
Panel Recommendation is Based
The petitioner provided the following
information:
A. Reports on Non-Unions
The petitioner submitted 35 articles (5
describing capacitive coupling devices
and 30 describing the use of pulsed
electromagnetic field devices) reporting
outcomes for over 5,600 patients.
According to the petitioner, these
studies indicate the device’s ability to
promote osteogenesis in patients with
an established non-union, which may
include previously failed surgical
attempts to establish union.
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B. Reports on Adjunctive Lumbar Spinal
Fusion
The petitioner has submitted eight
articles (one utilizing capacitive
coupling devices and seven utilizing
pulsed electromagnetic field devices)
reporting outcomes for over 1,100
patients. According to the petitioner,
these studies indicate the device’s
ability to promote osteogenesis in
patients as an adjunct to the treatment
of lumbar spinal fusion for one or two
levels.
C. Reports on Preclinical Findings
The petitioner has cited 21 articles in
the petition amendment describing
studies in animal models. The animal
studies described in the petition
amendment were designed to evaluate
new signals, dose/response
relationships, and the potential
pathways of bone repair processes. In
addition, 14 articles were presented that
describe studies in cell culture systems
designed to examine the mechanism(s)
of action of various electrical stimuli in
bone. These studies, conducted at the
cellular level, were intended to
investigate the sequence of events that
occur as a result of electrical
stimulation, the interaction of the fields
at the level of the cell membrane with
regard to ion channels and receptor
interaction, and signal transduction; and
to identify cell types that do or do not
respond to electrical stimulation.
The Panel recommended that the
proposed special controls (Ref 1.) were
sufficient to control for the risk of
electric shock, burn, skin irritation, and/
or allergic reaction; adverse interaction
with electrical implants; adverse
interaction with internal/external
fixation devices; and biological risks
(carcinogenicity, genotoxicity,
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mutagenicity and teratology). However,
the Panel believed that there was
insufficient evidence presented by the
petitioner to control for the risk of
inconsistent or ineffective treatment
because there is a lack of knowledge
about how waveform characteristics
(e.g., pulse duration, amplitude, power,
frequency) affect the clinical response to
treatment. This concern was also
expressed by the Panel regarding
potential modifications made to the
device. It is not known how a change to
the device output due to device
modifications may impact the clinical
response to treatment. The Panel
requested additional clinical data and/
or special controls to control for the risk
of inconsistent or ineffective treatment
that may occur as the result of device
modifications (Ref. 2).
VIII. FDA’s Findings
FDA believes that certain device
modifications are unlikely to adversely
affect device safety and effectiveness
and such changes could be adequately
validated using bench-top testing.
However, FDA also believes that there
was not adequate evidence in the
petition to establish that the petitioner’s
proposed special controls could be used
to adequately mitigate the risk of
inconsistent or ineffective treatment.
Additional evidence is required to
establish special controls, including
preclinical test methods, to mitigate the
risk of inconsistent or ineffective
treatment.
Because FDA has concerns about the
ability of the petitioner’s proposed
special controls to control the risk of
inconsistent and ineffective treatment,
FDA is unable to conclude that general
controls and the petitioner’s proposed
special controls would provide a
reasonable assurance of safety and
effectiveness for this device type.
Therefore, based on the currently
available information, FDA concurs
with the Panel’s recommendation to
retain the non-invasive bone growth
stimulator as a class III device.
IX. 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.
X. Analysis of Impacts
FDA has examined the impacts of this
notice under Executive Order 12866 and
the Regulatory Flexibility Act (5 U.S.C.
601–612), and the Unfunded Mandates
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1953
Reform Act of 1995 (Public Law 104–4).
Executive Order 12866 directs agencies
to assess all costs and benefits of
available regulatory alternatives and,
when regulation is necessary, to select
regulatory approaches that maximize
net benefits (including potential
economic, environmental, public health
and safety, and other advantages;
distributive impacts; and equity). The
agency believes that this reclassification
petition denial, if finalized, is not a
significant regulatory action as defined
by the Executive order.
The Regulatory Flexibility Act
requires agencies to analyze regulatory
options that would minimize any
significant impact of a rule on small
entities. If FDA accepts the Panel
recommendation and denies the petition
for reclassification, the regulatory status
of the device will remain the same as it
is now. Because this action, if finalized,
will maintain the status quo, the agency
certifies that the reclassification petition
denial will not have a significant
economic impact on a substantial
number of small entities.
Section 202(a) of the Unfunded
Mandates Reform Act of 1995 requires
that agencies prepare a written
statement, which includes an
assessment of anticipated costs and
benefits, before proposing ‘‘any rule that
includes any Federal mandate that may
result in the expenditure by State, local,
and tribal governments, in the aggregate,
or by the private sector, of $100,000,000
or more (adjusted annually for inflation)
in any one year.’’ The current threshold
after adjustment for inflation is $122
million, using the most current (2005)
Implicit Price Deflator for the Gross
Domestic Product. FDA does not expect
this reclassification petition action to
result in any 1-year expenditure that
would meet or exceed this amount.
XI. Federalism
FDA has analyzed this action in
accordance with the principles set forth
in Executive Order 13132. FDA has
determined that the action, if finalized,
would not contain policies that would
have substantial direct effects on the
States, on the relationship between the
National Government and the States, or
on the distribution of power and
responsibilities among the various
levels of government. Accordingly, the
agency concludes that the action does
not contain policies that have
federalism implications as defined in
the Executive order and, consequently,
a federalism summary impact statement
has not been prepared.
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Federal Register / Vol. 72, No. 10 / Wednesday, January 17, 2007 / Proposed Rules
XII. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this notice. Submit
a single copy of electronic comments or
two paper copies of mailed comments,
except that individuals may submit one
paper copy. Comments are to be
identified with the docket number
found in brackets in the heading of this
document. Received comments may be
seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
XIII. References
The following references have 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.
1. Reclassification petition from RS
Medical Corp., dated February 7, 2005, and
amendment dated November 30, 2005.
2. Orthopedic and Rehabilitation Devices
Panel Meeting Transcript, June 2, 2006.
Dated: January 5, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and
Radiological Health.
[FR Doc. E7–476 Filed 1–16–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF THE INTERIOR
Bureau of Indian Affairs
25 CFR Part 292
RIN 1076–AE81
Gaming on Trust Lands Acquired After
October 17, 1988
Bureau of Indian Affairs,
Interior.
ACTION: Proposed rule; reopening of
comment period.
mstockstill on PROD1PC61 with PROPOSALS
AGENCY:
SUMMARY: This document reopens the
comment period for the proposed rule
published on December 4, 2006 (71 FR
70335), which establishes procedures
that an Indian tribe must follow in
seeking to conduct gaming on lands
acquired after October 17, 1988.
DATES: Comments must be received on
or before February 1, 2007.
ADDRESSES: You may submit comments
identified by the number 1076–AE81, by
any of the following methods:
• Federal rulemaking portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Fax: 202–273–3153.
• Mail: Mr. George Skibine, Director,
Office of Indian Gaming, Office of the
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13:17 Jan 16, 2007
Jkt 211001
Deputy Assistant Secretary—Policy and
Economic Development, 1849 C Street,
NW., Mail Stop 3657–MIB, Washington,
DC 20240.
• Hand Delivery: Office of Indian
Gaming, Office of the Deputy Assistant
Secretary—Policy and Economic
Development, 1849 C Street, NW., Mail
Stop 3657–MIB, Washington, DC, from
9 a.m. to 4 p.m., Monday through
Friday.
FOR FURTHER INFORMATION CONTACT:
George Skibine, Office of Indian
Gaming, Acting Deputy Assistant
Secretary—Policy and Economic
Development, Mail Stop 3657–MIB,
1849 C Street, NW., Washington, DC
20240; Telephone (202) 219–4066.
On
October 5, 2006 (71 FR 58769), the
Bureau of Indian Affairs (BIA)
published a proposed rule to establish
procedures that an Indian tribe must
follow in seeking to conduct gaming on
lands acquired after October 17, 1988.
The Indian Gaming Regulatory Act
allows Indian tribes to conduct class II
and class III gaming activities on land
acquired after October 17, 1988, only if
the land meets certain exceptions. This
proposed rule establishes a process for
submitting and considering applications
from Indian tribes seeking to conduct
class II or class III gaming activities on
lands acquired in trust after October 17,
1988.
On December 4, 2006, the BIA
published a notice making corrections
to the proposed rule and extended the
comment period until December 19,
2006. Eighteen comments were received
after December 19, 2006. Several of
these comments raise substantive issues
that may result in modification of the
proposed rule. The comment period is
reopened to allow consideration of the
comments received after December 19,
2006, and to allow additional time for
comment on the proposed rule.
Comments must be received on or
before February 1, 2007.
SUPPLEMENTARY INFORMATION:
Dated: January 11, 2007.
Michael D. Olsen,
Principal Deputy Assistant Secretary—Indian
Affairs.
[FR Doc. E7–511 Filed 1–16–07; 8:45 am]
BILLING CODE 4310–4N–P
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ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R04–OAR–2005–KY–0004–200609;
FRL–8269–4]
Approval and Promulgation of
Implementation Plans; Kentucky:
Performance Testing and Open
Burning
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
SUMMARY: EPA is proposing to approve
revisions to the Kentucky State
Implementation Plan (SIP), submitted
by the Commonwealth of Kentucky,
through the Kentucky Department of Air
Quality (KDAQ), on September 6, 2005.
The revisions include changes to
Kentucky Administrative Regulations
(KAR) Title 401, Chapters 50:045,
‘‘Performance tests,’’ and 63:005, ‘‘Open
burning.’’ The changes included in the
proposed SIP revisions are part of
Kentucky’s strategy to attain and
maintain the 8-hour ozone and fine
particulate (PM2.5) national ambient air
quality standards (NAAQS) by reducing
emissions of PM2.5 and precursors to
ozone. EPA is proposing to approve
Kentucky’s SIP revisions pursuant to
section 110 of the Clean Air Act (CAA).
DATES: Written comments must be
received on or before February 16, 2007.
ADDRESSES: Submit your comments,
identified by Docket ID Number, ‘‘EPA–
R04–OAR–2005–KY–0004,’’ by one of
the following methods:
1. www.regulations.gov: Follow the
on-line instructions for submitting
comments.
2. E-mail: hou.james@epa.gov.
3. Fax: 404–562–9019.
4. Mail: ‘‘EPA–R04–OAR–2005–KY–
0004,’’ Regulatory Development Section,
Air Planning Branch, Air, Pesticides and
Toxics Management Division, U.S.
Environmental Protection Agency,
Region 4, 61 Forsyth Street, SW.,
Atlanta, Georgia 30303–8960.
5. Hand Delivery or Courier: James
Hou, Regulatory Development Section,
Air Planning Branch, Air, Pesticides and
Toxics Management Division, U.S.
Environmental Protection Agency,
Region 4, 61 Forsyth Street, SW.,
Atlanta, Georgia 30303–8960. Such
deliveries are only accepted during the
Regional Office’s normal hours of
operation. The Regional Office’s official
hours of business are Monday through
Friday, 8:30 a.m. to 4:30 p.m., excluding
Federal holidays.
Instructions: Direct your comments to
Docket ID Number, ‘‘EPA–R04–OAR–
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Agencies
[Federal Register Volume 72, Number 10 (Wednesday, January 17, 2007)]
[Proposed Rules]
[Pages 1951-1954]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-476]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 888
[Docket No. 2005P-0121]
Orthopedic Devices; Reclassification of Non-Invasive Bone Growth
Stimulator
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of panel recommendation.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is issuing for public
comment the recommendation of the Orthopaedic and Rehabilitation
Devices Panel to deny a petition to reclassify the non-invasive bone
growth stimulator from class III to class II. The Panel made this
recommendation after reviewing the reclassification petition submitted
by RS Medical Corp., as well as consideration of presentations made at
the Panel meeting by the petitioner, FDA, and members of the public.
FDA is also issuing for public comment its findings on the Panel's
recommendation. After considering any public comments on the Panel's
recommendation and FDA's findings, FDA will approve or deny the
reclassification petition by order in the form of a letter to the
petitioner. FDA's decision on the reclassification petition will be
announced in the Federal Register.
DATES: Submit written or electronic comments by April 17, 2007.
ADDRESSES: You may submit comments, identified by Docket No. 2005P-
0121, by any of the following methods:
Electronic Submissions
Submit electronic comments in the following ways:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
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SUPPLEMENTARY INFORMATION section of this document.
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Radiological Health (HFZ-410), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 240-276-3600.
SUPPLEMENTARY INFORMATION:
I. Background (Regulatory Authorities)
The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301
et. seq.), as amended by the Medical Device Amendments of 1976 (the
1976 amendments) (Public Law 94-295), the Safe Medical Devices Act of
1990 (the SMDA) (Public Law 101-629), and the Food and Drug
Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115),
established a comprehensive system for the regulation of medical
devices intended for human use. Section 513 of the act (21 U.S.C. 360c)
established three categories (classes) of devices, depending on 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).
Under section 513 of the act, devices that were in commercial
distribution before May 28, 1976 (the date of enactment of the 1976
amendments), generally referred to as preamendments devices, are
classified after FDA has: (1) Received a recommendation from a device
classification panel (an FDA advisory committee); (2) published the
panel's recommendation for comment, along with a proposed regulation
classifying the device; and (3) published a final regulation
classifying the device. FDA has classified most preamendments devices
under these procedures.
Devices that were not in commercial distribution prior to May 28,
1976, generally referred to as postamendments devices, are classified
automatically by statute (section 513(f) of the act into class III
without any FDA rulemaking process. Those devices remain in class III
and require premarket approval, unless and until the device is
reclassified into class I or II or FDA issues an order finding the
device to be substantially equivalent, under section 513(i) of the 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 act (21 U.S.C. 360(k)) and part 807 of the
regulations (21 CFR part 807).
Reclassification of classified postamendments devices is governed
by section 513(f)(3) of the act. This section provides that FDA may
initiate the reclassification of a device classified into class III
under section 513(f)(1) of the act, or the manufacturer or importer of
a device may petition the Secretary of Health and Human Services (the
Secretary) for the issuance of an order classifying the device in class
I or class II. FDA's regulations in 21 CFR 860.134 set forth the
procedures for the filing and review of a petition for
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reclassification of such class III devices. In order to change the
classification of the device, it is necessary that the proposed new
class have sufficient regulatory controls to provide reasonable
assurance of the safety and effectiveness of the device for its
intended use.
Under section 513(f)(3)(B)(i) of the act, the Secretary may, for
good cause shown, refer a petition to a device classification panel.
The Panel shall make a recommendation to the Secretary respecting
approval or denial of the petition. Any such recommendation shall
contain (1) A summary of the reasons for the recommendation, (2) a
summary of the data upon which the recommendation is based, and (3) an
identification of the risks to health (if any) presented by the device
with respect to which the petition was filed.
II. Regulatory History of the Device
In accordance with section 513(f)(1) of the act, the non-invasive
bone growth stimulators were automatically classified into class III
because they were not introduced or delivered for introduction into
interstate commerce for commercial distribution before May 28, 1976,
and have not been found substantially equivalent to a device placed in
commercial distribution after May 28, 1976, which was subsequently
classified or reclassified into class II or class I. Therefore, the
device can not be placed in commercial distribution unless it is
reclassified under section 513(f)(3), or subject to an approved
premarket approval application (PMA) under section 515 of the act (21
U.S.C. 360e).
In a petition dated February 7, 2005, that was received by FDA on
February 9, 2005, RS Medical Corp. requested that FDA reclassify the
non-invasive bone growth stimulator from class III to class II. (Ref.
1) The petition was submitted under section 513(e) of the act but FDA
is reviewing the petition under section 513(f)(3) of the act because
that section contains the appropriate procedures for reclassification
of postamendments devices. FDA requested additional information and the
petitioner amended the petition on August 1, 2005. In accordance with
the act and the regulations, FDA referred the petition as amended to an
FDA Advisory Committee, the Orthopedic and Rehabilitation Devices Panel
(the Panel) for its recommendations on the requested reclassification.
III. Description of Device Proposed for Reclassification
The Petitioner identified the device as follows:
A non-invasive bone growth stimulator is a device that provides
stimulation through electrical and/or magnetic fields to facilitate the
healing of nonunion fractures and lumbar spinal fusions. The
stimulation may be delivered through capacitive coupling (CC) with
electrodes placed directly over the treatment site or through pulsed
electromagnetic fields (PEMF) with treatment coils placed into a brace
or over a cast at the treatment site. The device is intended for use:
(1) For the treatment of established nonunion fractures acquired
secondary to trauma (excluding vertebrae and flat bone), and (2) as an
adjunct to the treatment of lumbar spinal fusion surgery for one or two
levels. The device consists of an output waveform generator, either
battery-powered or AC-powered; a user interface with visual and/or
audible alarms; and electrodes or coils to deliver the stimulation.
IV. Recommendations of the Panel
On June 2, 2006, the Panel deliberated on information in RS
Medical's petition; the presentations made by RS Medical, FDA, and
members of the public; and their own experience with non-invasive bone
growth stimulators (Ref. 2). The Panel voted four to two to recommend
that non-invasive bone growth stimulators be retained in class III.
V. Risks to Health
The Panel identified the following risks to health associated with
the non-invasive bone growth stimulator:
A. Electric Shock
A patient or health care professional could be shocked from the use
and operation of the device via an AC line voltage exposure during
charging, circuitry malfunction, connection/disconnection of electrodes
or coils, control circuit failure, damaged channel jacks, defective
electrodes/coil delivering inappropriate output, faulty lead wires,
inappropriate output, poor connection between electrodes/coils and lead
wires, poor solder on circuit board, reposition of electrodes/coils
during treatment, and use of AC current source during treatment.
B. Burn
A patient or health care professional could be burned from the use
and operation of the device via an AC line voltage exposure during
charging, connection/disconnection of the electrodes/coils or control
unit while receiving treatment, defective electrodes/coil delivering
inappropriate output, incorrect electrode/coil size or alteration,
inappropriate output, use of AC current source for treatment, and use
of control unit and battery charger while sleeping.
C. Skin Irritation and/or Allergic Reaction
A patient could experience skin irritation and/or allergic reaction
associated with the use and operation of the device via the use of non-
biocompatible device materials and/or non-biocompatible electrode gel.
D. Inconsistent or Ineffective Treatment
A patient could receive inconsistent or ineffective treatment via
battery deterioration, control circuit failure, defective electrode/
coils, device damage from dropping or bumping, device short circuits,
driver circuit failure, electromagnetic interference (EMI) or radio
frequency interference (RFI), failure to follow prescribed use,
hardware failure, improper position of electrodes/coil, inappropriate
output, incorrect battery/battery charger, ineffective output, low
battery voltage, poor interface between electrodes/coil and patient,
and switch failure.
E. Adverse Interaction with Electrical Implants
A patient with electrically-powered implants (such as cardiac
pacemakers, cardiac defibrillators, and neuro-stimulators) could
experience an adverse interaction with an implanted electrical device
via EMI or RFI.
F. Internal/External Fixation Devices
A patient with internal or external fixation devices could receive
inconsistent or ineffective treatment due to interaction of the device
with the metallic fixation devices via interference with treatment
field through magnetic field interaction and/or electrical inductance
within metallic device.
G. Biological Risks: Carcinogenicity, Genotoxicity, Mutagenicity, and
Teratology
A patient may experience adverse biologic affects resulting from
prolonged exposure to the treatment signal via biologic interaction
with the treatment signal at a cellular level.
VI. Summary of Reasons for Recommendation
The Panel believes that the non-invasive bone growth stimulator
should be retained in class III because there is insufficient
information in this petition
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to establish that special controls in association with general controls
would provide a reasonable assurance of the safety and effectiveness of
the device.
VII. Summary of Data Upon Which the Panel Recommendation is Based
The petitioner provided the following information:
A. Reports on Non-Unions
The petitioner submitted 35 articles (5 describing capacitive
coupling devices and 30 describing the use of pulsed electromagnetic
field devices) reporting outcomes for over 5,600 patients. According to
the petitioner, these studies indicate the device's ability to promote
osteogenesis in patients with an established non-union, which may
include previously failed surgical attempts to establish union.
B. Reports on Adjunctive Lumbar Spinal Fusion
The petitioner has submitted eight articles (one utilizing
capacitive coupling devices and seven utilizing pulsed electromagnetic
field devices) reporting outcomes for over 1,100 patients. According to
the petitioner, these studies indicate the device's ability to promote
osteogenesis in patients as an adjunct to the treatment of lumbar
spinal fusion for one or two levels.
C. Reports on Preclinical Findings
The petitioner has cited 21 articles in the petition amendment
describing studies in animal models. The animal studies described in
the petition amendment were designed to evaluate new signals, dose/
response relationships, and the potential pathways of bone repair
processes. In addition, 14 articles were presented that describe
studies in cell culture systems designed to examine the mechanism(s) of
action of various electrical stimuli in bone. These studies, conducted
at the cellular level, were intended to investigate the sequence of
events that occur as a result of electrical stimulation, the
interaction of the fields at the level of the cell membrane with regard
to ion channels and receptor interaction, and signal transduction; and
to identify cell types that do or do not respond to electrical
stimulation.
The Panel recommended that the proposed special controls (Ref 1.)
were sufficient to control for the risk of electric shock, burn, skin
irritation, and/or allergic reaction; adverse interaction with
electrical implants; adverse interaction with internal/external
fixation devices; and biological risks (carcinogenicity, genotoxicity,
mutagenicity and teratology). However, the Panel believed that there
was insufficient evidence presented by the petitioner to control for
the risk of inconsistent or ineffective treatment because there is a
lack of knowledge about how waveform characteristics (e.g., pulse
duration, amplitude, power, frequency) affect the clinical response to
treatment. This concern was also expressed by the Panel regarding
potential modifications made to the device. It is not known how a
change to the device output due to device modifications may impact the
clinical response to treatment. The Panel requested additional clinical
data and/or special controls to control for the risk of inconsistent or
ineffective treatment that may occur as the result of device
modifications (Ref. 2).
VIII. FDA's Findings
FDA believes that certain device modifications are unlikely to
adversely affect device safety and effectiveness and such changes could
be adequately validated using bench-top testing. However, FDA also
believes that there was not adequate evidence in the petition to
establish that the petitioner's proposed special controls could be used
to adequately mitigate the risk of inconsistent or ineffective
treatment. Additional evidence is required to establish special
controls, including preclinical test methods, to mitigate the risk of
inconsistent or ineffective treatment.
Because FDA has concerns about the ability of the petitioner's
proposed special controls to control the risk of inconsistent and
ineffective treatment, FDA is unable to conclude that general controls
and the petitioner's proposed special controls would provide a
reasonable assurance of safety and effectiveness for this device type.
Therefore, based on the currently available information, FDA concurs
with the Panel's recommendation to retain the non-invasive bone growth
stimulator as a class III device.
IX. 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.
X. Analysis of Impacts
FDA has examined the impacts of this notice under Executive Order
12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the
Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this reclassification petition denial, if finalized, is not a
significant regulatory action as defined by the Executive order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. If FDA accepts the Panel recommendation and denies
the petition for reclassification, the regulatory status of the device
will remain the same as it is now. Because this action, if finalized,
will maintain the status quo, the agency certifies that the
reclassification petition denial will not have a significant economic
impact on a substantial number of small entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $122 million, using the most current (2005) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
reclassification petition action to result in any 1-year expenditure
that would meet or exceed this amount.
XI. Federalism
FDA has analyzed this action in accordance with the principles set
forth in Executive Order 13132. FDA has determined that the action, if
finalized, would not contain policies that would have substantial
direct effects on the States, on the relationship between the National
Government and the States, or on the distribution of power and
responsibilities among the various levels of government. Accordingly,
the agency concludes that the action does not contain policies that
have federalism implications as defined in the Executive order and,
consequently, a federalism summary impact statement has not been
prepared.
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XII. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this notice.
Submit a single copy of electronic comments or two paper copies of
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
XIII. References
The following references have 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.
1. Reclassification petition from RS Medical Corp., dated
February 7, 2005, and amendment dated November 30, 2005.
2. Orthopedic and Rehabilitation Devices Panel Meeting
Transcript, June 2, 2006.
Dated: January 5, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E7-476 Filed 1-16-07; 8:45 am]
BILLING CODE 4160-01-S