[Federal Register: December 2, 2003 (Volume 68, Number 231)]
[Rules and Regulations]
[Page 67365-67367]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02de03-8]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 872
[Docket No. 2002N-0305]
Medical Devices: Classification of the Dental Sonography Device
and Jaw Tracking Device
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is classifying the
dental sonography device into class I, when it is used to monitor
temporomandibular joint sounds, and into class II, when it is used to
interpret temporomandibular joint sounds for the diagnosis of
temporomandibular joint disorders and associated orofacial pain. FDA is
classifying the jaw tracking device into class I, when it is used to
monitor mandibular jaw positions relative to the maxilla, and into
class II, when it is used to interpret mandibular jaw positions
relative to the maxilla, for the diagnosis of temporomandibular joint
disorders and associated orofacial pain. Elsewhere in this issue of the
Federal Register, FDA is announcing the availability of a guidance
document that will serve as the special control for this device. FDA is
taking this action under the Federal Food, Drug, and Cosmetic Act (the
act) as amended by the Medical Device Amendments of 1976 (the 1976
amendments), the Safe Medical Devices Act of 1990 (the SMDA), the Food
and Drug Administration Modernization Act of 1997 (FDAMA) and the
Medical Device User Fee and Modernization Act of 2002 (MDUFMA).
DATES: This rule is effective January 2, 2004.
FOR FURTHER INFORMATION CONTACT: Mary S. Runner, Center for Devices and
Radiological Health (HFZ-480), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-827-5283.
SUPPLEMENTARY INFORMATION:
I. Background
The act (21 U.S.C. 301 et seq.), as amended by the 1976 amendments
(Public Law 94-295), the SMDA (Public Law 101-629), and FDAMA (Public
Law 105-115), established a comprehensive system for the regulation of
medical devices intended for human use. Section 513 of the act (21
U.S.C. 360c) established three categories (classes) of devices as a
function of 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, FDA refers to devices that were in
commercial distribution before May 28, 1976 (the date of enactment of
the 1976 amendments), generally referred to as preamendments devices,
are classified after FDA has: (1) Received a recommendation from a
device classification panel (an FDA advisory committee); (2) published
the panel's recommendation for comment, along with a proposed
regulation classifying the device; and (3) published a final regulation
classifying the device. FDA has classified most preamendments devices
under these procedures.
Devices that were not in commercial distribution before 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 FDA does the
following: (1) Reclassifies the device into class I or II; (2) issues
an order classifying the device into class I or II in accordance with
new section 513(f)(2) of the act, as amended by FDAMA; or (3) issues,
under section 513(i) of the act, an order finding the device as
substantially equivalent to a predicate device that does not require
premarket approval. FDA determines whether new devices are
substantially equivalent to preamendments devices by means of premarket
notification procedures as delineated in section 510(k) of the act (21
U.S.C. 360(k)) and part 807 of the regulations (21 CFR part 807).
Through premarket notification procedures, a person may, without
submission of a premarket approval application (PMA), market a
preamendments type device that has been classified into class III until
FDA issues a final regulation under section 515(b) of the act (21
U.S.C. 360e(b)) requiring premarket approval. Consistent with the act
and the regulations, FDA consulted with the Dental Products Advisory
Panel (the Panel), an FDA advisory committee, regarding the
classification of the dental sonography device and the jaw tracking
device.
II. Regulatory History of the Device
In the Federal Register of August 14, 2002 (67 FR 52901), FDA
proposed to classify the dental sonography device into class I when it
is used to monitor temporomandibular joint sounds, and into class II,
when it is used to interpret temporomandibular joint sounds for the
diagnosis of temporomandibular joint disorders and associated orofacial
pain. FDA also proposed to classify the jaw tracking device into class
I, when it is used to monitor mandibular jaw positions relative to the
maxilla, and into class II, when it is used to interpret mandibular jaw
positions relative to the maxilla, for the diagnosis of
temporomandibular joint disorders and associated orofacial pain.
FDA provided an opportunity for interested persons to comment on
the proposed regulation and guidance document until November 12, 2002.
FDA received one comment from a consumer, however, the comment was
irrelevant to the proposed rule because it was referring to a different
device. A manufacturer commented that the identification of the class
II sonography could be read to place a device in class II even if it
does not interpret sounds. The comment said that a device is
appropriately in class II if it interprets sounds. The comment further
suggested that FDA should define ``interpret'' to mean that the device
provides a specific diagnosis and not just meaningful output.
FDA agrees that the identification may not have been clear and has
revised Sec. 872.2050(b) by combining the last two sentences to
clarify that interpretation is a necessary part of the identification.
FDA disagrees that ``interpret'' should mean that a device provides a
specific diagnosis. FDA believes that it is necessary that the
manufacturer of a class II dental sonography device that
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goes beyond a simple display of raw data should provide clinical
information and verification that the information provided by these
devices has clinical and diagnostic validity, sensitivity, and
specificity and, therefore, the special control, in addition to the
general controls, is necessary to provide reasonable assurance of
safety and effectiveness.
III. Summary of Final Rule
FDA concurs that the dental sonography device and the jaw tracking
device, used to monitor temporomandibular joint sounds and mandibular
jaw positions relative to the maxilla, respectively, should be
classified into class I (general controls). General controls would
provide reasonable assurance of safety and effectiveness for these
devices for these intended uses. FDA, however, believes that the dental
sonography device and the jaw tracking device used to interpret
temporomandibular joint sounds and mandibular jaw positions relative to
the maxilla, respectively, for the diagnosis of temporomandibular joint
disorders and associated orofacial pain should be classified into class
II (special controls). Premarket notification for dental sonography and
jaw tracking devices with these intended uses should include clinical
information to demonstrate performance, as well as labeling instructing
the user on proper technique, interpretation of the device outputs, and
appropriate warnings and precautions. FDA concurs with the Panel's
recommendation that these devices should be subject to sale by or on
the order of a licensed practitioner.
FDA disagrees with the Panel that the class I devices should
require premarket notification because they meet the reserved criteria
of section 510(l) of the act. FDA believes that the intended uses of
monitoring sounds emanated from the temporomandibular joint or
monitoring mandibular jaw positions relative to the maxilla should be
exempt from premarket notification. FDA believes these devices for
these intended uses are not of substantial importance in preventing
impairment of human health, nor do they present an unreasonable risk of
illness or injury.
FDA, however, is classifying into class II, the dental sonography
device and the jaw tracking device used to interpret temporomandibular
joint sounds and mandibular jaw positions relative to the maxilla,
respectively, for the diagnosis of temporomandibular joint disorders
and associated orofacial pain. Section 510(m) of the act provides that
a class II device may be exempted from the premarket notification
requirements, if FDA determines that premarket notification is not
necessary to provide reasonable assurance of safety and effectiveness.
FDA concludes that premarket notification is necessary.
FDA has identified the following risks to health associated with
the class II devices as follows: (1) Electrical interference.
Electrical interference generated by these devices may affect
diagnostic and therapeutic medical devices, such as certain types of
cardiac pacemakers; (2) Improper treatment. There is no general
consensus or established standard of care regarding the interpretation
of the output of these devices. Therefore, a misdiagnosis of
temporomandibular joint disorders and associated orofacial pain may
lead to improper treatment.
IV. Special Controls Guidance Document
Elsewhere in this issue of the Federal Register, FDA is announcing
the availability of the guidance document entitled ``Class II Special
Controls Guidance Document: Dental Sonography and Jaw Tracking
Devices.'' This guidance document will serve as the special control for
the class II dental sonography and jaw tracking devices.
FDA believes that review of performance characteristics described
in the special controls guidance and appropriate labeling can ensure
that acceptable levels of performance for both safety and effectiveness
are addressed before marketing clearance. Thus, persons who intend to
market this device must submit to FDA a premarket notification
submission before marketing the device. Following the effective date of
the final classification rule, any firm submitting a 510(k) premarket
notification for these class II devices will need to address the issues
covered in the special control 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.
V. Environmental Impact
The agency has determined under 21 CFR 25.34(b) that this
classification 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 (2 U.S.C. 1501 et seq.). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives. If regulation is necessary, a
regulatory agency must plot a course that maximizes net benefits
(including potential economic, environmental, public health and safety,
and other advantages; distributive impacts; and equity). The agency
believes this final rule is consistent with the regulatory philosophy
and principles identified in the Executive order. Additionally, as
defined by the Executive order the final rule does not constitute a
significant regulatory action. As a result, the final rule is not
subject to review under 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. The class I devices are already subject to the
general controls provisions of the act. The special controls guidance
does not impose any new requirements on manufacturers of class I
devices. Manufacturers of the class II dental sonography and jaw
tracking devices currently are required to submit premarket
notifications. The guidance document reflects existing FDA practice in
the review of these premarket notifications. FDA expects that
manufacturers of cleared dental sonography and jaw tracking devices
will not have to take any additional action in response to this rule.
This rule will help expedite the review process for any new
manufacturers of these devices. The agency therefore certifies that the
final rule will not have a significant economic impact on a substantial
number of small entities. In addition, this final rule will not impose
costs of $100 million or more on either the private sector or State,
local, and tribal governments in the aggregate, and therefore a summary
statement of analysis under section 202(a) of the Unfunded Mandates
Reform Act of 1995 is not required.
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
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federalism implications as defined in the Executive order and,
consequently, a federalism summary impact statement is not required.
VIII. Paperwork Reduction Act of 1995
FDA concludes that the final rule contains no collections of
information. Therefore, clearance by the Office of Management and
Budget, according to the Paperwork Reduction Act of 1995 (44 U.S.C.
3501-3520) is not required.
List of Subjects in 21 CFR Part 872
Medical devices.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
872 is amended as follows:
PART 872--DENTAL DEVICES
0
1. The authority citation for 21 CFR part 872 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
0
2. Section 872.2050 is added to subpart B to read as follows:
Sec. 872.2050 Dental sonography device.
(a) Dental sonography device for monitoring--(1) Identification. A
dental sonography device for monitoring is an electrically powered
device, intended to be used to monitor temporomandibular joint sounds.
The device detects and records sounds made by the temporomandibular
joint.
(2) Classification. Class I. The device is exempt from the
premarket notification provisions of subpart E of part 807 of this
chapter subject to Sec. 872.9.
(b) Dental sonography device for interpretation and diagnosis--(1)
Identification. A dental sonography device for interpretation and
diagnosis is an electrically powered device, intended to interpret
temporomandibular joint sounds for the diagnosis of temporomandibular
joint disorders and associated orofacial pain. The device detects,
records, displays, and stores sounds made by the temporomandibular
joint during jaw movement. The device interprets these sounds to
generate meaningful output, either directly or by connection to a
personal computer. The device may be part of a system of devices,
contributing joint sound information to be considered with data from
other diagnostic components.
(2) Classification. Class II (special controls). The special
control for this device is FDA's guidance document entitled ``Class II
Special Controls Guidance Document: Dental Sonography and Jaw Tracking
Devices.''
0
3. Section 872.2060 is added to subpart B to read as follows:
Sec. 872.2060 Jaw tracking device.
(a) Jaw tracking device for monitoring mandibular jaw positions
relative to the maxilla--(1) Identification. A jaw tracking device for
monitoring mandibular jaw positions relative to the maxilla is a
nonpowered or electrically powered device that measures and records
anatomical distances and angles in three dimensional space, to
determine the relative position of the mandible with respect to the
location and position of the maxilla, while at rest and during jaw
movement.
(2) Classification. Class I (general controls). The device is
exempt from the premarket notification provisions of subpart E of part
807 of this chapter subject to Sec. 872.9.
(b) Jaw tracking device for interpretation of mandibular jaw
positions for the diagnosis--(1) Identification. A jaw tracking device
for interpretation of mandibular jaw positions relative to the maxilla
for the diagnosis of temporomandibular joint disorders and associated
orofacial pain is a nonpowered or electrically powered device that
measures and records anatomical distances and angles to determine the
relative position of the mandible in three dimensional space, with
respect to the location and position of the maxilla, while at rest and
during jaw movement. The device records, displays, and stores
information about jaw position. The device interprets jaw position to
generate meaningful output, either directly or by connection to a
personal computer. The device may be a part of a system of devices,
contributing jaw position information to be considered with data from
other diagnostic components.
(2) Classification. Class II (special controls). The special
control for this device is FDA's guidance document entitled ``Class II
Special Controls Guidance Document: Dental Sonography and Jaw Tracking
Devices.''
Dated: October 23, 2003.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 03-29863 Filed 12-1-03; 8:45 am]
BILLING CODE 4160-01-S