[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announcing the availability of a draft guidance document entitled 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