[Federal Register Volume 71, Number 31 (Wednesday, February 15, 2006)]
[Proposed Rules]
[Pages 7894-7897]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-2076]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 892
[Docket No. 2005N-0467]
Medical Devices; Radiology Devices; Reclassification of Bone
Sonometers
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is publishing a
proposed rule to reclassify bone sonometer devices from class III into
class II, subject to special controls. 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. Elsewhere in this issue of the Federal Register, FDA is
announcing the availability of a draft guidance document entitled
``Class II Special Controls Guidance Document: Bone Sonometers'' that
the agency proposes to use as a special control for these devices.
DATES: Submit comments by May 16, 2006.
ADDRESSES: You may submit comments, identified by Docket No. 2005N-
0467, by any of the following methods:
Electronic Submissions
Submit electronic comments in the following ways:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Agency Web site: http://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 e-mail. 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(s). and Regulatory Information Number (RIN) (if a RIN
number has been assigned) for this rulemaking. All comments received
may be posted without change to http://www.fda.gov/ohrms/dockets/default.htm, including any personal information provided. For detailed
instructions on submitting comments and additional information on the
rulemaking process, 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 http://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: Robert A. Phillips, Center for Devices
and Radiological Health (HFZ-470), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-1212, ext. 130.
SUPPLEMENTARY INFORMATION:
I. Regulatory Authority
The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301
et seq.), as amended by the Medical Device Amendments of 1979 (the 1976
amendments) (Public Law 94-295), the Safe Medical Devices Act of 1990
(SMDA) (Pub. L. 101-629), and the Food and Drug Administration
Modernization Act of 1997 (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
[[Page 7895]]
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 part 807 (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) 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 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 History of the Device
A bone sonometer is a postamendments device classified into class
III under section 513(f)(1) of the act. Therefore, this generic type of
device cannot be placed in commercial distribution unless it is
reclassified under section 513(f)(3), or is the subject of a PMA or
notice of completion of a product development protocol under section
515 of the act (21 U.S.C. 360e). Accordingly, under section 513(f)(3)
of the act, FDA is initiating this proposal to reclassify bone
sonometers from class III to class II when intended for the following:
(1) Determining the possible presence of osteoporosis and assessing
fracture risk, (2) monitoring bone changes over time, and/or (3)
assessing non-age-related bone loss.
III. Device Description
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. Bone sonometers are used for
determining the possible presence of osteoporosis and assessing
fracture risk; monitoring bone changes over time; and assessing non-
age-related bone loss. The primary components of the device are a
voltage generator, a transmitting transducer, a receiving transducer,
hardware, and software for reception and processing of the received
ultrasonic signal. By processing an ultrasonic signal propagated
through a bone, it is possible to estimate broadband ultrasonic
attenuation (BUA) and/or speed of sound (SOS). These two acoustic
parameters have also been shown in prospective clinical trials to
predict fracture incidence (Refs. 1 and 2). In this way, BUA and SOS
can be used to aid a physician in determining the possible presence of
osteoporosis and assessing fracture risk; monitoring bone changes over
time; and assessing non-age-related bone loss.
IV. Summary of the Data Upon Which the Reclassification is Based
FDA is proposing this reclassification based on experience with the
device and information on the benefits and risks of the device that
have developed since the device's classification into class III.
Specifically, distinct bone sonometers from different manufacturers
demonstrate similar performance and increases the agency's confidence
in this technology. In addition, a recent study of 149,524 women
compared four peripheral techniques, including bone sonometry,
peripheral dual energy x-ray absorptiometry (DEXA), finger DEXA, and
heel single x-ray absorpiometry, for their ability to predict fracture
incidence within one year of measurement. (Ref. 3.) The results show
that all four techniques were equally effective for this purpose.
Peripheral DEXA and finger DEXA are in class II.
Moreover, as discussed next, information regarding the risks of the
device, along with measures to mitigate these risks, has developed. FDA
believes this information is sufficient to establish special controls
for this device that will provide a reasonable assurance of its safety
and effectiveness if it is reclassified into class II.
V. Risks to Health
FDA believes that bone sonometers, when used for determining the
possible presence of osteoporosis and assessing fracture risk;
monitoring bone changes over time; or assessing non-age-related bone
loss; should be reclassified into class II because special controls, in
addition to general controls, can provide reasonable assurance of the
safety and effectiveness of the device, and there is sufficient
information to establish special controls to provide such assurance.
After considering the information regarding bone sonometer use and
technology, published literature, and medical device reports, FDA has
evaluated the risks to health associated with use of these devices. FDA
believes that electrical shock; electromagnetic compatibility; tissue
damage; and inaccurate measurement present risks to health associated
with the use of bone sonometers. The draft special controls guidance
document entitled ``Class II Special Controls Guidance Document: Bone
Sonometers'' aids in mitigating the risks by recommending performance
characteristics, safety testing, and appropriate labeling.
VI. Special Controls
Elsewhere in this issue of the Federal Register, FDA is publishing
a notice of availability of the draft guidance document entitled
``Class II Special Controls Guidance Document: Bone Sonometers,'' that
the agency is proposing to use as the special control for these device
types. The draft guidance document contains specific recommendations
with regard to device performance testing and other information that
should be included in a premarket (510(k)) notification submission.
Particular sections of the guidance document address the following: (1)
Electrical safety, (2) electromagnetic compatibility, (3) acoustic
intensity, (4) device performance characteristics, and (5) labeling.
FDA believes that this draft special controls guidance, in addition to
general controls, can address the risks to heath described in section V
of this document.
In table 1 of this document, FDA has identified the risks to health
associated
[[Page 7896]]
with the use of these devices in the first column and the recommended
mitigation measures identified in the draft class II special controls
guidance document in the second column. These recommendations will also
help ensure that the device has appropriate performance characteristics
and labeling for its use.
Following the effective date of any final reclassification rule
based on this proposal, any firm submitting a 510(k) submission for a
bone sonometer device will need to address the issues covered in the
class II special controls guidance document. However, the firm need
only show that its device meets the recommendations of the class II
special controls guidance document or in some other way provides
equivalent assurances of safety and effectiveness.
Table 1
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Identified Risk Recommended Mitigation Measures
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Electrical shock Electrical Safety
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Electromagnetic interference Electromagnetic Compatibility
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Tissue damage Acoustic Intensity
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Inaccurate measurement leading to Non-Clinical Testing
inappropriate therapy Clinical Testing
Labeling
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VII. FDA's Findings
FDA believes that bone sonometers should be reclassified into class
II because special controls, in addition to general controls, will
provide reasonable assurance of the safety and effectiveness of these
devices, and there is sufficient information to establish special
controls to provide such assurance. FDA, therefore, is proposing to
reclassify bone sonometers into class II and establish the class II
special controls guidance document as a special control for these
devices.
FDA believes for this type of device, premarket notification is
necessary to provide reasonable assurance of the device's safety and
effectiveness; therefore, the device would not be exempt from premarket
notification requirements (section 510 of the act). Thus, 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 device they intend to market.
VIII. Effective Date
FDA proposes that any final rule that may issue based on this
proposal become effective 30 days after its date of publication in the
Federal Register.
IX. 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.
X. Analysis of Impacts
FDA has examined the impacts of the proposed rule under Executive
Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the
Unfunded Mandates Reform Act of 1995 (Pub. L. 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
proposed 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 these devices from class III to
class II will relieve all 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.
The agency, therefore, certifies that this proposed rule, if finalized,
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 $115 million, using the most current (2003) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
proposed rule to result in any 1-year expenditure that would meet or
exceed this amount.
XI. Federalism
FDA has analyzed this proposed 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.
XII. Paperwork Reduction Act of 1995
FDA tentatively concludes that this proposed rule contains no
collections of information. Therefore, clearance by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(the PRA) (44 U.S.C. 3501-3520) is not required.
FDA also tentatively concludes that the special controls guidance
document identified by this proposed rule does not contain new
information collection provisions that are subject to review and
clearance by OMB under the PRA. Elsewhere in this issue of the Federal
[[Page 7897]]
Register, FDA is publishing a notice announcing the availability of the
draft guidance document entitled ``Class II Special Controls Guidance
Document: Bone Sonometers.'' The notice contains an analysis of the
paperwork burden for the draft guidance.
XIII. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
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.
XIV. 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. Bauer, D. C., et al., ``Broadband Ultrasound Attenuation
Predicts Fractures Strongly and Independently of Densitometry in
Older Women,'' Archives of Internal Medicine, 157, pp. 629-634,
1997.
2. Hans, D., et al., ``Ultrasonographic Heel Measurements to
Predict Hip Fracture in Elderly Women: The EPIDOS Prospective
Study,'' Lancet, 348, pp. 511-514, 1996.
3. Miller, P. D., et al., ``Prediction of Fracture Risk in
Postmenopausal White Women With Peripheral Bone Densitometry:
Evidence From the National Osteoporosis Risk Assessment,'' Journal
of Bone and Mineral Research, 17, pp. 2222-2230, 2002.
List of Subjects in 21 CFR Part 892
Medical devices, Radiation protection, X-rays.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
the authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 892 be amended as follows:
PART 892--RADIOLOGY DEVICES
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.
2. Add section 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 processing of the received ultrasonic signal.
(b) Classification. Class II (special controls). The special
control for this device is FDA's ``Class II Special Controls Guidance
Document: Bone Sonometers.'' See Sec. 892.1(e) of this chapter for the
availability of this guidance document.
Dated: January 17, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E6-2076 Filed 2-14-06; 8:45 am]
BILLING CODE 4160-01-S