[Federal Register Volume 73, Number 138 (Thursday, July 17, 2008)]
[Rules and Regulations]
[Pages 40967-40970]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-16354]


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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.

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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.

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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-
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 http://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