Medical Devices; Radiology Devices; Reclassification of Bone Sonometers, 40967-40970 [E8-16354]
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Federal Register / Vol. 73, No. 138 / Thursday, July 17, 2008 / Rules and Regulations
errors and to clarify the rules. Therefore,
we find that it is in the public interest
to make this rule effective upon
publication.
Executive Order 12866, as Amended
We have consulted with the Office of
Management and Budget (OMB) and
determined that this final rule does not
meet the criteria for a significant
regulatory action under Executive Order
12866, as amended. Thus, it was not
subject to OMB review. We have also
determined that this rule meets the
plain language requirement of Executive
Order 12866, as amended.
Regulatory Flexibility Act
We certify that this direct final rule
will not have a significant economic
impact on a substantial number of small
entities as it affects individuals only.
Therefore, a regulatory flexibility
analysis as provided in the Regulatory
Flexibility Act, as amended, is not
required.
Paperwork Reduction Act
This rule imposes no additional
reporting or recordkeeping requirements
requiring OMB clearance.
§ 404.339 How do I become entitled to
mother’s or father’s benefits as a surviving
spouse?
*
*
*
*
*
(a) You are the widow or widower of
the insured and meet the conditions
described in § 404.335(a);
*
*
*
*
*
3. Amend § 404.340 by revising the
heading and introductory text to read as
follows:
I
§ 404.340 How do I become entitled to
mother’s or father’s benefits as a surviving
divorced spouse?
You may be entitled to mother’s or
father’s benefits as the surviving
divorced wife or the surviving divorced
husband on the earnings record of
someone who was fully or currently
insured when she or he died. You are
entitled to these benefits if—
*
*
*
*
*
I 4. Amend § 404.348 by revising the
heading and the introductory text to
read as follows:
§ 404.348 When is a child living with me in
my care?
section, the insured was living with you
and providing at least one-half of your
support, and any period during which
he or she was not living with you and
providing one-half of your support did
not exceed the lesser of 3 months or
one-half of the period beginning with
the month of your birth.
Subpart H—[Amended]
7. The authority citation for subpart H
of part 404 continues to read as follows:
I
Authority: Secs. 205(a) and 702(a)(5) of the
Social Security Act (42 U.S.C. 405(a) and
902(a)(5)).
8. Amend § 404.762 by revising the
heading and the introductory text to
read as follows:
I
§ 404.762 What is acceptable evidence of
having a child in my care?
What evidence we will ask for
depends upon whether the child is
living with you or with someone else.
You will be asked to give the following
evidence:
*
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[FR Doc. E8–16332 Filed 7–16–08; 8:45 am]
(Catalog of Federal Domestic Assistance
Program Nos. 96.001, Social Security—
Disability Insurance; 96.002, Social
Security—Retirement Insurance; 96.004,
Social Security—Survivors Insurance.)
A child who has been living with you
for at least 30 days is in your care
unless—
*
*
*
*
*
I 5. Amend § 404.349 by revising the
section heading to read as follows:
List of Subjects in 20 CFR Part 404
§ 404.349 When is a child living apart from
me in my care?
Administrative practice and
procedure, Blind, Disability benefits,
Old-age, Survivors and Disability
Insurance, Reporting and recordkeeping
requirements, Social Security.
*
Dated: July 10, 2008.
Michael J. Astrue,
Commissioner of Social Security.
§ 404.364 When is a grandchild or
stepgrandchild dependent?
AGENCY:
*
HHS.
For the reasons set out in the
preamble, we are amending part 404 of
chapter III of title 20 of the Code of
Federal Regulations as set forth below:
I
PART 404—FEDERAL OLD-AGE,
SURVIVORS AND DISABILITY
INSURANCE (1950—)
Subpart D—[Amended]
1. The authority citation for subpart D
of part 404 continues to read as follows:
I
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40967
Authority: Secs. 202, 203(a) and (b), 205(a),
216, 223, 225, 228(a)–(e), and 702(a)(5) of the
Social Security Act (42 U.S.C. 402, 403(a)
and (b), 405(a), 416, 423, 425, 428(a)–(e), and
902(a)(5)).
2. Amend § 404.339 by revising the
heading and paragraph (a) to read as
follows:
I
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I 6. Amend § 404.364 by revising the
heading and paragraph (b), and by
adding paragraph (c) to read as follows:
*
*
*
*
(b) You were living with the insured
in the United States and receiving at
least one-half of your support from him
or her for the year before he or she
became entitled to old-age or disability
benefits or died; or if the insured had a
period of disability that lasted until he
or she became entitled to benefits or
died, for the year immediately before
the month in which the period of
disability began. If you were born
during the 1-year period, the insured
must have lived with you and provided
at least one-half of your support for
substantially all of the period that
begins on the date of your birth.
Paragraph (c) of this section explains
when the substantially all requirement
is met.
(c) The ‘‘substantially all’’
requirement will be met if, at one of the
times described in paragraph (b) of this
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BILLING CODE 4191–02–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 892
[Docket No. FDA–2005–N–0346] (formerly
Docket No. 2005N–0467)
Medical Devices; Radiology Devices;
Reclassification of Bone Sonometers
ACTION:
Food and Drug Administration,
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is issuing a final
rule to reclassify bone sonometer
devices from class III into class II,
subject to special controls. FDA is
taking this action on its own initiative
after reviewing recent scientific and
technological studies regarding bone
sonometer devices. Elsewhere in this
issue of the Federal Register, FDA is
announcing the availability of a
guidance document entitled ‘‘Guidance
for Industry and FDA Staff; Class II
Special Controls Guidance Document:
Bone Sonometers’’ that will serve as the
special control for these devices.
DATES: This final rule is effective August
18, 2008.
FOR FURTHER INFORMATION CONTACT:
Robert A. Phillips, Center for Devices
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Federal Register / Vol. 73, No. 138 / Thursday, July 17, 2008 / Rules and Regulations
and Radiological Health (HFZ–470),
Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,
240–276–3666.
SUPPLEMENTARY INFORMATION:
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I. Regulatory Authority
The Federal Food, Drug, and Cosmetic
Act (the act), as amended by the
Medical Device Amendments of 1976
(the 1976 amendments) (Public Law 94–
295), the Safe Medical Devices Act
(SMDA) (Public Law 101–629), the Food
and Drug Administration Modernization
Act of 1997 (FDAMA) (Public Law 105–
115), the Medical Device User Fee and
Modernization Act of 2002 (MDUFMA)
(Public Law 107–250), the Medical
Devices Technical Corrections Act
(MDTCA) (Public Law 108–214), and
the Food and Drug Administration
Amendments Act (FDAAA), establishes
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 type; and (3)
published a final regulation classifying
the device type. 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
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procedures in section 510(k) of the act
(21 U.S.C. 360(k)) and 21 CFR part 807.
A preamendments device that has
been classified into class III may be
marketed, by means of premarket
notification procedures, without
submission of a premarket approval
application (PMA), until FDA issues a
final regulation under section 515(b) of
the act (21 U.S.C. 360e(b)) requiring
premarket approval.
Section 513(f)(3) of the act allows
FDA to initiate reclassification of a
postamendment device classified into
class III under section 513(f)(1) of the
act, or the manufacturer or importer of
a device to petition the Secretary of the
Department of Health and Human
Services 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
reclassification of such class III devices.
To change the classification of the
device, it is necessary that the proposed
new classification have sufficient
regulatory controls to provide
reasonable assurance of the safety and
effectiveness of the device for its
intended use.
II. Regulatory Background of the Device
In the Federal Register of February
15, 2006 (71 FR 7894), FDA published
a proposed rule to reclassify bone
sonometers from class III (premarket
approval) into class II (special controls)
after reviewing current technological
and scientific developments.
Specifically, the Center for Devices and
Radiological Health (CDRH) reviewed
recent studies addressing performance
characteristics of bone sonometers
manufactured by different companies
and determined that, when combined
with mitigation measures to offset the
risks of use associated with these
devices, special controls would be
adequate to assure the safety and
effectiveness of bone sonometers.
Interested persons were invited to
comment on the proposed rule by May
16, 2006. FDA also identified the draft
guidance document entitled ‘‘Draft
Guidance for Industry and FDA Staff;
Class II Special Controls Draft Guidance
Document; Bone Sonometers’’ as the
proposed special control capable of
providing reasonable assurance of safety
and effectiveness for these devices (71
FR 7976).
III. Analysis of Comments and FDA’s
Response
FDA received a number of comments
on the proposed rule and draft guidance
document. Each of the comments
supported the reclassification of bone
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sonometers from class III into class II,
but made specific suggestions with
regard to the general scope and clinical
testing sections of the guidance. FDA
agreed with the following suggested
changes to the special controls guidance
and revised the document accordingly:
(1) Determining device-specific T-score
thresholds; (2) removing
recommendations regarding monitoring;
(3) increasing the number of women
recommended for reproducibility
studies; (4) recommending intermediateterm precision studies in addition to
short-term precision studies; (5) deleting
the recommendation that separate Tscore thresholds be determined for
reference databases based on nonCaucasian females or males of any
ethnicity; (6) recommending
justification for exclusion criteria
regarding recent use of bone-active
drugs; (7) recommending stratification
of patients by bone mineral density
rather than age for reproducibility
testing; (8) recommending inclusion of
axial dual energy x-ray absorptiometry
data in order to determine level of
discordance with bone sonometer; and
(9) recommending testing to assess
temperature dependence of
measurements.
The agency disagreed with the
suggestion to require that bone
sonometers express measurements in
terms of fracture risk instead of Tscores. FDA recognizes the diagnostic
significance of fracture risk and the
limitations of T-scores. Previouslyapproved bone sonometers, however,
express measurements in terms of Tscores because they were developed and
approved prior to recent publications
reporting limitations of T-scores.
Because currently approved bone
sonometers express measurements in
terms of T-scores, firms wishing to
demonstrate substantial equivalence of
new bone sonometers with similar
indications and technology may choose
to express diagnostic measurements in
terms of T-scores. The agency
distinguishes this goal from that of
demonstrating the safety and
effectiveness of bone sonometers using
new technology, or, with new
indications for use, such as fracture risk
measurement. As yet, a standardized
measure of fracture risk has not been
introduced into clinical practice,
although FDA is aware that such efforts
are currently underway. The agency
encourages these efforts. If and when a
standard method to predict fracture risk
becomes available, FDA may revise the
bone sonometers guidance.
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IV. FDA’s Conclusions
Based on the information discussed in
the preamble to the proposed rule (71
FR 7894), and revisions to the guidance
as discussed previously in this
document, FDA concludes that special
controls, in conjunction with general
controls, will provide reasonable
assurance of the safety and effectiveness
of bone sonometers. The agency is,
therefore, reclassifying bone sonometers
from class III (premarket approval) into
class II (special controls) when intended
for determining the possible presence of
osteoporosis and/or assessing non-agerelated bone loss. Elsewhere in this
issue of the Federal Register, FDA is
announcing the availability of the
guidance document entitled ‘‘Guidance
for Industry and FDA Staff; Class II
Special Controls Guidance Document;
Bone Sonometers’’ as the special control
capable of providing reasonable
assurance of safety and effectiveness for
these devices. Following the effective
date of this final classification rule, any
firm submitting a 510(k) premarket
notification for a bone sonometer
intended for determining the possible
presence of osteoporosis and/or
assessing non-age-related bone loss will
need to address the issues covered in
the special controls guidance. However,
the firm need only show that its device
meets the recommendations of the
guidance or in some other way provides
equivalent assurances of safety and
effectiveness.
FDA is now codifying the
classification for bone sonometers by
adding new § 892.1180. For the
convenience of the reader, 21 CFR 892.1
has been amended to inform the reader
where to find guidance documents
referenced in 21 CFR part 892.
Section 510(m) of the act provides
that FDA may exempt a class II device
from the premarket notification
requirements under section 510(k) of the
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
and, therefore, this type of device is not
exempt from premarket notification
requirements. Persons intending to
market this type of device must submit
to FDA a premarket notification, prior to
marketing the device, which contains
information about the bone sonometer(s)
intended for marketing.
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V. Environmental Impact
The agency has determined under 21
CFR 25.34(b) that this reclassification
action is of a type that does not
individually or cumulatively have a
significant effect on the human
environment. Therefore, neither an
environmental assessment nor an
environmental impact statement is
required.
VI. Analysis of Impacts
FDA has examined the impacts of the
final rule under Executive Order 12866,
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 certifies that this final rule 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. Reclassification of bone
sonometers from class III to class II
relieves manufacturers of this device
type of the costs of complying with the
premarket approval requirements in
section 515 of the act. Because
reclassification will reduce regulatory
costs with respect to this device type, it
will impose no significant economic
impact on any small entities, and it may
permit small potential competitors to
enter the marketplace by lowering their
costs.
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 $127
million, using the most current (2006)
Implicit Price Deflator for the Gross
Domestic Product. FDA does not expect
this final rule to result in any 1-year
expenditure that would meet or exceed
this amount.
VII. Federalism
FDA has analyzed this final rule in
accordance with the principles set forth
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40969
in Executive Order 13132. FDA has
determined that the rule does not
contain policies that 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 has concluded that the rule does
not contain policies that have
federalism implications as defined in
the Executive order and, consequently,
a federalism summary impact statement
is not required.
VIII. Paperwork Reduction Act of 1995
This final rule contains no new
collections of information. Therefore,
clearance by the Office of Management
and Budget under the Paperwork
Reduction Act of 1995 is not required.
This final rule also designates a
guidance document as a special control.
Elsewhere in this issue of the Federal
Register, FDA is publishing a notice
announcing the availability of that
guidance document entitled ‘‘Guidance
for Industry and FDA Staff; Class II
Special Controls Guidance Document:
Bone Sonometers,’’ which contains a
Paperwork Reduction Act analysis for
that guidance.
List of Subjects in 21 CFR Part 892
Medical devices, Radiation
protection, X-rays.
I Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 892 is
amended as follows:
PART 892—RADIOLOGY DEVICES
1. The authority citation for 21 CFR
part 892 continues to read as follows:
I
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 371.
I
2. Add § 892.1(e) to read as follows:
§ 892.1
Scope.
*
*
*
*
*
(e) Guidance documents referenced in
this part are available on the Internet at
https://www.fda.gov/cdrh/guidance.html.
I 3. Add § 892.1180 to subpart B to read
as follows:
§ 892.1180
Bone sonometer.
(a) Identification. A bone sonometer is
a device that transmits ultrasound
energy into the human body to measure
acoustic properties of bone that indicate
overall bone health and fracture risk.
The primary components of the device
are a voltage generator, a transmitting
transducer, a receiving transducer, and
hardware and software for reception and
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processing of the received ultrasonic
signal.
(b) Classification. Class II (special
controls). The special control for this
device is FDA’s ‘‘Guidance for Industry
and FDA Staff; Class II Special Controls
Guidance Document: Bone
Sonometers.’’ See § 892.1(e) for the
availability of this guidance document.
available at the Maryland Department of
the Environment, 1800 Washington
Boulevard, Suite 705, Baltimore,
Maryland 21230.
Dated: July 2, 2008.
Daniel G. Schultz,
Director, Center for Devices and Radiological
Health.
[FR Doc. E8–16354 Filed 7–16–08; 8:45 am]
I. Background
BILLING CODE 4160–01–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R03–OAR–2007–1000; FRL–8691–6]
Approval and Promulgation of Air
Quality Implementation Plans;
Maryland; Amendments to the Control
of Volatile Organic Compound
Emissions From Portable Fuel
Containers
Environmental Protection
Agency (EPA).
ACTION: Final rule.
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AGENCY:
SUMMARY: EPA is approving a State
Implementation Plan (SIP) revision
submitted by the State of Maryland.
This revision establishes and requires
the control of emissions of volatile
organic compounds (VOCs) portable
fuel containers. EPA is approving this
SIP revision in accordance with the
Clean Air Act (CAA).
DATES: Effective Date: This final rule is
effective on August 18, 2008.
ADDRESSES: EPA has established a
docket for this action under Docket ID
Number EPA–R03–OAR–2007–1000. All
documents in the docket are listed on
the https://www.regulations.gov Web
site. Although listed in the electronic
docket, some information is not publicly
available, i.e., confidential business
information (CBI) or other information
whose disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available either electronically through
https://www.regulations.gov or in hard
copy for public inspection during
normal business hours at the Air
Protection Division, U.S. Environmental
Protection Agency, Region III, 1650
Arch Street, Philadelphia, Pennsylvania
19103. Copies of the State submittal are
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FOR FURTHER INFORMATION CONTACT:
Gobeail McKinley, (215) 814–2033, or
by e-mail at mckinley.gobeail@epa.gov.
SUPPLEMENTARY INFORMATION:
On December 3, 2007 (72 FR 67878),
EPA published a notice of proposed
rulemaking (NPR) for the State of
Maryland. The NPR proposed approval
of the control of VOC emissions from
portable fuel containers. The formal SIP
revision was submitted by the Maryland
Department of the Environment (MDE)
on June 18, 2007.
II. Summary of SIP Revision
Maryland’s amendments to the
portable fuel containers rule incorporate
the changes to the 2007 Ozone
Transport Commission (OTC) Model
Rule for portable fuel containers that
was based on the changes adopted by
California Air Resources Board (CARB)
in July 2006. The amendments address
the fact that the original rule did not
apply to kerosene containers which
were offered for sale in place of
compliant portable fuel containers.
Other amended incorporations include:
Modifying the existing spout regulations
in order to improve spillage control;
elimination of the fuel flow rate and fill
level performance standards;
elimination of the automatic shutoff
performance standard; new containers
must be certified for use and sale by the
manufacturer through CARB; and, new
portable fuel container testing
procedures to streamline testing. The
amendments, which includes a one-year
sell-through period, apply to any person
who sells, supplies, advertises or offers
for sale, or manufactures for sale
portable fuel containers
and/or spouts. Owners of portable fuel
containers and/or spouts purchased
prior to the July 1, 2007 implementation
date are not required to purchase or
replace the containers and/or spouts
with newer, compliant fuel containers.
There are no manufacturers of portable
fuel containers in Maryland.
The rationale for EPA’s proposed
action are explained in the NPR and
will not be restated here. On December
6, 2007, EPA received a comment on its
December 3, 2007 NPR. A summary of
the comment submitted and EPA’s
response is provided in section III of
this document.
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III. Summary of Public Comments and
EPA Response
Comment: The commenter expressed
a concern that in New Jersey, the
container designs are not easy to use,
especially for those who use these
containers only occasionally, and some
people might defeat the designs thereby
eliminating any air quality benefits. The
commenter asks if EPA would
investigate whether the containers will
really bring a significant clean air
benefit.
Response: These amendments,
submitted by the State of Maryland
concerning the control of VOCs from
portable fuel containers, are being
considered by EPA, on the basis that
they strengthen the existing Maryland
SIP. There is no comparable Federal
rule to reduce VOC emissions from
portable fuel containers. The State of
Maryland has estimated that these
amendments will result in an emission
reduction potential of 1.6 tons per day
of VOC in the Baltimore nonattainment
area, and 6 tons per day of VOC
statewide beginning in 2009.1 The
commenter does not dispute that the
Maryland portable fuel container rule
will reduce VOC emissions, but rather
speculates that the emissions reduction
features of the fuel containers might be
defeated by end-users and asks EPA to
investigate whether the rule will
achieve ‘‘significant clean air benefits.’’
For purposes of approving this
regulation as a SIP-strengthening
measure, EPA does not have to
determine if the emissions reductions
from this regulation are or are not
‘‘significant.’’ EPA merely needs to
determine if the rule will generate some
additional reductions that would not be
achieved by the current Maryland SIP.
The commenter does not challenge that
at least some amount of reductions will
occur due to the implementation of the
fuel container rule.
Section 110 of the CAA provides the
statutory framework for approval/
disapproval of SIP revisions. Under the
CAA, EPA establishes NAAQS for
certain pollutants. The CAA establishes
a joint Federal and State program to
control air pollution and protect the
public health. States are required to
prepare SIPs for each designated ‘‘air
quality region’’ within their borders.
The SIP must specify emission limits
1 Maryland is not at this time requesting EPA to
approve a quantified amount of VOC emission
reduction from the enactment of its regulation.
Rather, this regulation has been submitted by
Maryland, and is being considered by EPA, on the
basis that it strengthens the existing Maryland SIP.
EPA will only review and approve a specific
amount of emissions reductions after receiving a
proper request to do so from the State of Maryland.
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]]>Agencies
[Federal Register Volume 73, Number 138 (Thursday, July 17, 2008)]
[Rules and Regulations]
[Pages 40967-40970]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-16354]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 892
[Docket No. FDA-2005-N-0346] (formerly Docket No. 2005N-0467)
Medical Devices; Radiology Devices; Reclassification of Bone
Sonometers
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule
to reclassify bone sonometer devices from class III into class II,
subject to special controls. FDA is taking this action on its own
initiative after reviewing recent scientific and technological studies
regarding bone sonometer devices. Elsewhere in this issue of the
Federal Register, FDA is announcing the availability of a guidance
document entitled ``Guidance for Industry and FDA Staff; Class II
Special Controls Guidance Document: Bone Sonometers'' that will serve
as the special control for these devices.
DATES: This final rule is effective August 18, 2008.
FOR FURTHER INFORMATION CONTACT: Robert A. Phillips, Center for
Devices
[[Page 40968]]
and Radiological Health (HFZ-470), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 240-276-3666.
SUPPLEMENTARY INFORMATION:
I. Regulatory Authority
The Federal Food, Drug, and Cosmetic Act (the act), as amended by
the Medical Device Amendments of 1976 (the 1976 amendments) (Public Law
94-295), the Safe Medical Devices Act (SMDA) (Public Law 101-629), the
Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public
Law 105-115), the Medical Device User Fee and Modernization Act of 2002
(MDUFMA) (Public Law 107-250), the Medical Devices Technical
Corrections Act (MDTCA) (Public Law 108-214), and the Food and Drug
Administration Amendments Act (FDAAA), establishes 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 type; and (3) published a final regulation
classifying the device type. 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 21 CFR part 807.
A preamendments device that has been classified into class III may
be marketed, by means of premarket notification procedures, without
submission of a premarket approval application (PMA), until FDA issues
a final regulation under section 515(b) of the act (21 U.S.C. 360e(b))
requiring premarket approval.
Section 513(f)(3) of the act allows FDA to initiate
reclassification of a postamendment device classified into class III
under section 513(f)(1) of the act, or the manufacturer or importer of
a device to petition the Secretary of the Department of Health and
Human Services 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 reclassification
of such class III devices. To change the classification of the device,
it is necessary that the proposed new classification have sufficient
regulatory controls to provide reasonable assurance of the safety and
effectiveness of the device for its intended use.
II. Regulatory Background of the Device
In the Federal Register of February 15, 2006 (71 FR 7894), FDA
published a proposed rule to reclassify bone sonometers from class III
(premarket approval) into class II (special controls) after reviewing
current technological and scientific developments. Specifically, the
Center for Devices and Radiological Health (CDRH) reviewed recent
studies addressing performance characteristics of bone sonometers
manufactured by different companies and determined that, when combined
with mitigation measures to offset the risks of use associated with
these devices, special controls would be adequate to assure the safety
and effectiveness of bone sonometers. Interested persons were invited
to comment on the proposed rule by May 16, 2006. FDA also identified
the draft guidance document entitled ``Draft Guidance for Industry and
FDA Staff; Class II Special Controls Draft Guidance Document; Bone
Sonometers'' as the proposed special control capable of providing
reasonable assurance of safety and effectiveness for these devices (71
FR 7976).
III. Analysis of Comments and FDA's Response
FDA received a number of comments on the proposed rule and draft
guidance document. Each of the comments supported the reclassification
of bone sonometers from class III into class II, but made specific
suggestions with regard to the general scope and clinical testing
sections of the guidance. FDA agreed with the following suggested
changes to the special controls guidance and revised the document
accordingly: (1) Determining device-specific T-score thresholds; (2)
removing recommendations regarding monitoring; (3) increasing the
number of women recommended for reproducibility studies; (4)
recommending intermediate-term precision studies in addition to short-
term precision studies; (5) deleting the recommendation that separate
T-score thresholds be determined for reference databases based on non-
Caucasian females or males of any ethnicity; (6) recommending
justification for exclusion criteria regarding recent use of bone-
active drugs; (7) recommending stratification of patients by bone
mineral density rather than age for reproducibility testing; (8)
recommending inclusion of axial dual energy x-ray absorptiometry data
in order to determine level of discordance with bone sonometer; and (9)
recommending testing to assess temperature dependence of measurements.
The agency disagreed with the suggestion to require that bone
sonometers express measurements in terms of fracture risk instead of T-
scores. FDA recognizes the diagnostic significance of fracture risk and
the limitations of T-scores. Previously-approved bone sonometers,
however, express measurements in terms of T-scores because they were
developed and approved prior to recent publications reporting
limitations of T-scores. Because currently approved bone sonometers
express measurements in terms of T-scores, firms wishing to demonstrate
substantial equivalence of new bone sonometers with similar indications
and technology may choose to express diagnostic measurements in terms
of T-scores. The agency distinguishes this goal from that of
demonstrating the safety and effectiveness of bone sonometers using new
technology, or, with new indications for use, such as fracture risk
measurement. As yet, a standardized measure of fracture risk has not
been introduced into clinical practice, although FDA is aware that such
efforts are currently underway. The agency encourages these efforts. If
and when a standard method to predict fracture risk becomes available,
FDA may revise the bone sonometers guidance.
[[Page 40969]]
IV. FDA's Conclusions
Based on the information discussed in the preamble to the proposed
rule (71 FR 7894), and revisions to the guidance as discussed
previously in this document, FDA concludes that special controls, in
conjunction with general controls, will provide reasonable assurance of
the safety and effectiveness of bone sonometers. The agency is,
therefore, reclassifying bone sonometers from class III (premarket
approval) into class II (special controls) when intended for
determining the possible presence of osteoporosis and/or assessing non-
age-related bone loss. Elsewhere in this issue of the Federal Register,
FDA is announcing the availability of the guidance document entitled
``Guidance for Industry and FDA Staff; Class II Special Controls
Guidance Document; Bone Sonometers'' as the special control capable of
providing reasonable assurance of safety and effectiveness for these
devices. Following the effective date of this final classification
rule, any firm submitting a 510(k) premarket notification for a bone
sonometer intended for determining the possible presence of
osteoporosis and/or assessing non-age-related bone loss will need to
address the issues covered in the special controls guidance. However,
the firm need only show that its device meets the recommendations of
the guidance or in some other way provides equivalent assurances of
safety and effectiveness.
FDA is now codifying the classification for bone sonometers by
adding new Sec. 892.1180. For the convenience of the reader, 21 CFR
892.1 has been amended to inform the reader where to find guidance
documents referenced in 21 CFR part 892.
Section 510(m) of the act provides that FDA may exempt a class II
device from the premarket notification requirements under section
510(k) of the 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 and,
therefore, this type of device is not exempt from premarket
notification requirements. Persons intending to market this type of
device must submit to FDA a premarket notification, prior to marketing
the device, which contains information about the bone sonometer(s)
intended for marketing.
V. Environmental Impact
The agency has determined under 21 CFR 25.34(b) that this
reclassification action is of a type that does not individually or
cumulatively have a significant effect on the human environment.
Therefore, neither an environmental assessment nor an environmental
impact statement is required.
VI. Analysis of Impacts
FDA has examined the impacts of the final rule under Executive
Order 12866, 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 certifies
that this final rule 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. Reclassification of bone sonometers from class III
to class II relieves manufacturers of this device type of the costs of
complying with the premarket approval requirements in section 515 of
the act. Because reclassification will reduce regulatory costs with
respect to this device type, it will impose no significant economic
impact on any small entities, and it may permit small potential
competitors to enter the marketplace by lowering their costs.
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 $127 million, using the most current (2006) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount.
VII. Federalism
FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies that 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 has concluded
that the rule does not contain policies that have federalism
implications as defined in the Executive order and, consequently, a
federalism summary impact statement is not required.
VIII. Paperwork Reduction Act of 1995
This final rule contains no new collections of information.
Therefore, clearance by the Office of Management and Budget under the
Paperwork Reduction Act of 1995 is not required.
This final rule also designates a guidance document as a special
control. Elsewhere in this issue of the Federal Register, FDA is
publishing a notice announcing the availability of that guidance
document entitled ``Guidance for Industry and FDA Staff; Class II
Special Controls Guidance Document: Bone Sonometers,'' which contains a
Paperwork Reduction Act analysis for that guidance.
List of Subjects in 21 CFR Part 892
Medical devices, Radiation protection, X-rays.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
892 is amended as follows:
PART 892--RADIOLOGY DEVICES
0
1. The authority citation for 21 CFR part 892 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
0
2. Add Sec. 892.1(e) to read as follows:
Sec. 892.1 Scope.
* * * * *
(e) Guidance documents referenced in this part are available on the
Internet at https://www.fda.gov/cdrh/guidance.html.
0
3. Add Sec. 892.1180 to subpart B to read as follows:
Sec. 892.1180 Bone sonometer.
(a) Identification. A bone sonometer is a device that transmits
ultrasound energy into the human body to measure acoustic properties of
bone that indicate overall bone health and fracture risk. The primary
components of the device are a voltage generator, a transmitting
transducer, a receiving transducer, and hardware and software for
reception and
[[Page 40970]]
processing of the received ultrasonic signal.
(b) Classification. Class II (special controls). The special
control for this device is FDA's ``Guidance for Industry and FDA Staff;
Class II Special Controls Guidance Document: Bone Sonometers.'' See
Sec. 892.1(e) for the availability of this guidance document.
Dated: July 2, 2008.
Daniel G. Schultz,
Director, Center for Devices and Radiological Health.
[FR Doc. E8-16354 Filed 7-16-08; 8:45 am]
BILLING CODE 4160-01-S
