[Federal Register Volume 67, Number 157 (Wednesday, August 14, 2002)]
[Proposed Rules]
[Pages 52901-52905]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-20499]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 872
[Docket No. 02N-0305]
Dental Devices; Classification of the Dental Sonography Device
and the Jaw Tracking Device
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing 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 is
also proposing 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 is
publishing the recommendations of the Dental Products Advisory Panel
(the panel) regarding the classification of these devices in this
document. After considering public comments on the proposed
classification, FDA will publish a final regulation classifying these
devices. This action is being taken to establish sufficient regulatory
controls that will provide reasonable assurance of the safety and
effectiveness of these devices. Elsewhere in this issue of the Federal
Register, FDA is publishing a notice of availability of a draft
guidance document that would serve as the special control for the class
II devices if this proposal becomes final.
DATES: Submit written or electronic comments by November 12, 2002.
ADDRESSES: Submit written or electronic comments to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to
http://www.fda.gov/dockets/ecomments.
[[Page 52902]]
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 Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301
et seq.), as amended by the Medical Device Amendments of 1976 (the 1976
amendments) (Public Law 94-295), the Safe Medical Devices Act of 1990
(Public Law 101-629), and the Food and Drug Administration
Modernization Act of 1997 (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, 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; and (3) published a final regulation
classifying the device. FDA has classified most preamendments devices
under these procedures.
A device that was not in commercial distribution before May 28,
1976, generally referred to as a postamendments device, is 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: (1) The device is
reclassified into class I or II; (2) FDA 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) 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
previously offered devices by means of the premarket notification
procedures in section 510(k) of the act (21 U.S.C. 360(k)) and 21 CFR
part 807 of the regulations.
A preamendments device that has been classified into class III may
be marketed, by means of the 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.
FDAMA added a new section 510(l) to the act. New section 510(l) of
the act provides that a class I device is exempt from the premarket
notification requirements under section 510(k) of the act, unless the
device is intended for a use which is of substantial importance in
preventing impairment of human health or it presents a potential
unreasonable risk of illness or injury. Hereafter, these are referred
to as ``reserved criteria.'' Such an exemption permits manufacturers to
introduce into commercial distribution generic types of devices without
first submitting a premarket notification to FDA. FDA believes that
certain changes to devices within a generic type that is generally
exempt may make the device intended for a use which is of substantial
importance in preventing impairment of human health or may make the
device present a potential unreasonable risk of illness or injury.
Accordingly, devices changed in this manner would fall within the
reserved criteria under section 510(l) of the act and would require
premarket notification. For example, FDA considers a class I device to
be subject to premarket notification requirements if the device
operates using a different fundamental scientific technology than that
used by a legally marketed device in that generic type.
FDAMA also added a new section 510(m) to the act. New section
510(m) of the act provides that a class II device may be exempted from
the premarket notification requirements under section 510(k) of the
act, if the agency determines that premarket notification is not
necessary to assure the safety and effectiveness of the device.
II. Recommendation of the Panel
In the Federal Register of August 12, 1987 (52 FR 30082), FDA
published a final rule classifying dental devices. At that time, FDA
was not aware that the dental sonography device and the jaw tracking
device were preamendments devices, and inadvertently omitted
classifying them.
Consistent with the act and the regulations, at a public meeting,
held on August 4, 1998, FDA consulted with the panel, an FDA advisory
committee, regarding the classification of these devices.
A. Identification
FDA is proposing the following device identifications based on the
panel's recommendation and the agency's review:
1. The class I dental sonography device is an electrically powered
device, intended to be used to monitor temporomandibular joint sounds.
The device is used to detect and record sounds made by the
temporomandibular joint.
2. The class II dental sonography device 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 a part of a system
of devices, contributing joint sound information to be considered with
data from other diagnostic components.
3. The class I jaw tracking device is a nonpowered or electrically
powered device used to monitor mandibular jaw positions relative to the
maxilla. The device 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.
4. The class II jaw tracking device is an electrically powered
device, intended to interpret mandibular jaw positions relative to the
maxilla, for the diagnosis of temporomandibular joint disorders and
associated orofacial pain. The device 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 joint position. The
device interprets jaw position to generate meaningful output, 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.
[[Page 52903]]
B. Recommended Classification of the Panel
During a public meeting, held on August 4, 1998, the panel made the
classification recommendations (Ref. 1) for the dental sonography
device and the jaw tracking device. The panel recommended that these
devices be classified into class I (general controls), and that the
devices should be subject to premarket notification. The panel also
recommended that these devices be restricted to sale by, or on the
order of a licensed dentist or physician (Sec. 801.109 (21 CFR
801.109)).
C. Summary of Reasons for Recommendation
The panel concluded that safety and effectiveness of the dental
sonography device and the jaw tracking device can reasonably be assured
by general controls. Specifically, the panel believed that safety and
effectiveness of both devices can be reasonably assured by registration
and listing (section 510 of the act); general requirements concerning
reports (21 CFR 820.180) and complaint files (21 CFR 820.198); and good
manufacturing practices requirements (section 520(f) of the act (21
U.S.C. 360j(f).) The panel also recommended that these devices be
restricted to sale by, or on the order of a licensed dentist or
physician (Sec. 801.109).
D. Summary of the Data Upon Which the Recommendation Was Based
The panel believes that these devices have provided dental
practitioners adjunctive diagnostic information, as a part of the
treatment of temporomandibular joint disorders, for over 23 years. When
used with other dental devices and clinical techniques, these devices
help the clinician to diagnose symptoms related to malfunction of the
temporomandibular joint and associated musculature.
After reviewing the literature provided to panel members by FDA
(Refs. 2 to 34); information provided by device manufacturers; several
panel members' personal knowledge of and clinical experience with the
devices; and in consideration of the consensus derived from the open
panel discussion, the panel gave the following reasons in support of
its recommendation to classify these devices into class I: (1) The
devices provide adjunctive information in the form of temporomandibular
joint sounds and relative jaw position, not otherwise available to the
clinician; (2) no invasive procedures are required; (3) no energy is
applied to craniofacial structures; and (4) the devices have been used
for many years without documented medical devices reports or other
published incident reports.
E. Risks to Health
The panel identified the following risks to health associated with
the dental sonography device and the jaw tracking device:
1. Electrical Interference
Electrical interference generated by these devices may affect
diagnostic and therapeutic medical devices, such as certain types of
cardiac pacemakers. Manufacturers should validate the isolation of
electrical circuitry of these devices from other medical devices.
2. Improper Treatment
There is no general consensus or established standard of care
regarding interpretation of the output of these devices. Therefore, a
misdiagnosis of a condition or abnormality may result in improper or
unnecessary therapeutic intervention. The outputs of these devices are
adjunctive to other diagnostic and therapeutic modalities.
III. Proposed Classification
FDA concurs that the dental sonography device and the jaw tracking
device intended to be used for monitoring sounds made by the
temporomandibular joint 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 of these devices for these intended uses. FDA,
however, believes that the dental sonography device and jaw tracking
device intended to interpret temporomandibular joint sounds and
mandibular jaw positions for the diagnosis of temporomandibular joint
disorders and associated orofacial pain should be classified into class
II (special controls). Premarket notifications for dental sonography
and jaw tracking devices with these intended uses should include
clinical data to demonstrate performance, as well as labeling
instructing the user on proper technique, interpretation of the device
outputs, and appropriate warnings and precautions. FDA tentatively
concurs with the panel's recommendation that these devices should be
restricted to sale by or on the order of a licensed dentist or
physician (Sec. 801.109).
FDA disagrees with the panel that the class I devices should
require premarket notification because they meet the reserved criteria
of new section 510(1) of the act. FDA believes that the intended uses
of monitoring sounds emanated from the temporomandibular joint and
mandibular jaw positions should be exempt from premarket notification.
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 proposing that the jaw tracking device and the
dental sonography device when used to interpret temporomandibular joint
position or sounds for the diagnosis of temporomandibular joint
disorder and associated orofacial pain be class II. As noted
previously, section 510(m) of the act provides that a class II device
may be exempted from the premarket notification requirements under
section 510(k) of the act, if the agency determines that premarket
notification is not necessary to provide reasonable assurance of the
safety and effectiveness of the device. FDA tentatively concludes that
premarket notification is necessary to provide reasonable assurance of
the safety and effectiveness of the jaw tracking device and the dental
sonography device when used to interpret temporomandibular joint
position or sounds for the diagnosis of temporomandibular joint
disorder and associated orofacial pain.
IV. Special Controls
FDA has included the special controls that it believes are
necessary to provide reasonable assurance of the safety and
effectiveness of the devices proposed for class II in the draft
guidance document entitled ``Class II Special Controls Guidance
Document: Dental Sonography and Jaw Tracking Devices; Guidance for
Industry and FDA Reviewers.'' FDA intends this guidance to serve as the
special control for these devices, if FDA classifies them in class II.
Elsewhere in this issue of the Federal Register, FDA is publishing a
notice of availability of the draft guidance document. The draft
guidance document sets forth recommendations on 510(k) submissions for
the class II devices on device characterization, intended use and
indications for use, preclinical and bench testing, device comparison,
instructions for use, clinical information, and software validation.
The draft guidance document would address the risk of electrical
interference by assuring that the 510(k) includes preclinical and bench
testing concerning this risk and by assuring that the device labeling
includes adequate information for the user to minimize the risk of
electrical interference. The guidance document
[[Page 52904]]
would address the risk of improper treatment by assuring that the
510(k) includes clinical information on this risks, by assuring that
the labeling includes adequate information for the health professional
using the device, and by assuring that the manufacturer has properly
validated the software. If adopted, following the effective date of a
final rule classifying the device, any firm submitting a 510(k)
premarket nitification for the device would need to address the issues
covered in the special control guidance. However, the firm would need
to show only 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 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 proposed rule under Executive
Order 12866 and 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 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 consistent with the regulatory philosophy and
principles identified in the Executive order. In addition, the proposed
rule is not a significant regulatory action as defined by the Executive
order and so 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. If FDA finalizes this rule, it
would impose no new requirements on manufacturers of class I devices.
Manufacturers of class II jaw tracking and dental sonography 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
class II jaw tracking and dental sonography devices will not have to
take any additional action in response to this rule, if FDA finalizes
this rule. This rule will help expedite the review process for any new
manufacturers of these devices. The agency therefore certifies that
this proposed rule, if issued, will not have a significant economic
impact on a substantial number of small entities. In addition, this
proposed 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 or analysis under section
202(a) of the Unfunded Mandates Reform Act of 1995 is not required.
VII. Paperwork Reduction Act of 1995
FDA tentatively concludes that this rule contains no collections of
information. Therefore, clearance by the Office of Management and
Budget under the Paperwork Reduction Act of 1995 is not required.
VIII. Proposed Implementation Plan
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. Comments
You may submit written or electronic comments regarding this
proposal to the Dockets Management Branch (see ADDRESSES) by November
12, 2002. You should submit two copies of any comments. Individuals may
submit one copy. You must identify comments with the docket number
found in brackets in the heading of this document. You may see any
comments that FDA receives in the Dockets Management Branch between 9
a.m. and 4 p.m., Monday through Friday.
X. References
The following references have been placed on display in the Dockets
Management Branch (see ADDRESSES) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. Dental Products Panel Meeting, Transcript and Meeting
Minutes, August 4, 1998.
2. Airoldi, R. L., L. M. Gallo, and S. Palla, ``Precision of the
Jaw Tracking System JAWS-3D,'' Journal of Orofacial Pain, 8: 155-
164, 1994.
3. Balkhi, K. M., R. H. Tallents, B. Goldin, and J. A. Catania,
``Error Analysis of a Magnetic Jaw-Tracking Device,'' Journal of
Craniomandibular Disorders: Facial & Oral Pain, 5: 51-56, 1991.
4. Braun, B. and E. L. Schiffman, ``The Validity and Predictive
Value of Four Assessment Instruments for Evaluation of the Cervical
Stomatognathic Systems,'' Journal of Craniomandibular Disorders:
Facial & Oral Pain, 5: 239-244, 1991.
5. Copper, B. C. and D. D. Rabuzzi, ``Myofacial Pain Dysfunction
Syndrome: A Clinical Study of Asymptomatic Subjects,'' Laryngoscope
94, January: 68-75, 1984.
6. Cooper, B. C., M. Alleva, D. L. Cooper, and F. E. Lucente,
``Myofacial Pain Dysfunction: Analysis of 476 Patients,''
Laryngoscope 96, October: 1099-1106, 1986.
7. Feine, J. S., M. O. Hutchins, and J. P. Lund, ``An Evaluation
of the Criteria Used to Diagnose Mandibular Dysfunction With the
Mandibular Kinesiograph,'' The Journal of Prosthetic Dentistry, 60:
374-380, 1988.
8. Friction, J. R. ``Recent Advances in Temporomandibular
Disorders and Orofacial Pain,'' Journal of the American Dental
Association, 122: 24-32, 1991.
9. Gay, T., C. N. Bertolami, R. B. Donoff, D. A. Keith, and J.
P. Kelly, ``The Acoustical Characteristics of the Normal and
Abnormal Temporomandibular Joint,'' Journal of Oral and
Maxillofacial Surgery, 45: 397-407,1987.
10. Gay, T. and C. N. Bertolami, ``The Accoustical
Characteristics of the Normal Temporomandibular Joint,'' Journal of
Dental Research, 67: 56-60, 1988.
11. Greene, C. S. and D. M. Laskin, ``Long-Term Status of TMJ
Clicking in Patients With Myofacial Pain and Dysfunction,'' Journal
of the American Dental Association, 117: 461-465, 1983.
12. Hampf, G., V. Aalberg, and V. Sunden, ``Assessment of
Patients Suffering From Chronic Orofacial Pain of Nonspecific
Origin,'' Journal of Craniomandibular Disorders: Facial & Oral Pain,
4: 30-34, 1990.
13. Kerstein, R. B. and S. Farrell, ``Treatment of Myofacial
Pain-Dysfunction Syndrome With Occlusal Equilibration,'' The Journal
of Prosthetic Dentistry, 63: 695-700, 1990.
14. Laskin, D. M. and S. Block, ``Diagnosis and Treatment of
Myofacial Pain-Dysfunction (MPD) Syndrome,'' The Journal of
Prosthetic Dentistry, 56: 75-83, 1986.
15. Laskin, D. M. and C. S. Greene, ``Technological Methods in
the Diagnosis and Treatment of Temporomandibular Disorders,''
International Journal of Technology Assessment in Health Care, 6:
558-568, 1990.
16. Lederman, K. H., ``Patients With Restored Occlusions. Part
I: TMJ Dysfunction Determined by a Pantographic Reproducibility
Index,'' The Journal of Prosthetic Dentistry, 47: 198-205, 1982.
17. Levitt, S. R. and M. W. McKinney, ``Appropriate Use of
Predictive Values in Clinical Decision Making and Evaluating
Diagnostic Tests for TMD,'' Journal of Orofacial Pain, 8: 298-308,
1994.
18. Lund, J. P., Widmer, C. G., and J. S. Feive, ``Validity of
Diagnostic and Monitoring Tests Used for Temporomandibular
Disorders,'' Journal of Dental Research, 74: 1133-1143, 1995.
19. Maeda, Y., M. Okada, T. Mori, K. Enomoto, M. Sogo, and Y.
Okuno, ``Development of a Mandibular Tracking Device with Six
Degrees of Freedom Using Optoelectronic System,'' Journal of the
Osaka University Dental School, 32: 45-50, 1992.
[[Page 52905]]
20. McNeill, C., N. D. Mohl, J. Rugh, and T. Tanaka,
``Temporomandibular Disorders Diagnosis, Management, Education and
Research,'' Journal of the American Dental Association, 120: 253-
263, 1990.
21. Minagi, S., H. Watanabe, T. Sato, and H. Tsuru, ``The
Relationship Between Balancing-Side Occlusal Contact Patterns and
Temporomandibular Joint in Humans: Proposition of the Concept of
Balancing-Side Protection,''Journal of Craniomandibular Disorders:
Facial & Oral Pain, 4: 251-256, 1990.
22. Mohl, N. D., J. P. Lund, C. G. Widmer, and W. D. McCall,
``Devices for the Diagnosis and Treatment of Temporomandibular
Disorders. Part II: Electromyography and Sonography,'' The Journal
of Prosthetic Dentistry, 63: 332-336, 1990.
23. Mohl, N. D., W. D. McCall, Jr., J. P. Lund, and O. Plesh,
``Devices for the Diagnosis and Treatment of Temporomandibular
Disorders. Part I: Introduction, Scientific Evidence, and Jaw
Tracking,'' The Journal of Prosthetic Dentistry, 63: 198-201, 1990.
24. Garcia-Moreira, C., F. Angeles-Medina, H. Gonzalez-Gomez, A.
Nuno Licono, J. Garcia-Ruiz, A. Galicia-Arias, and M. Rodriguez-
Espinoza, ``Improved Automated Recording of Masticatory Reflexes
Through Analysis of Effort Trajectory During Biofeedback,'' Medical
Progress Through Technology, 20: 63-73, 1994.
25. Nihon, J., ``A Study of Temporomandibular Joint Sounds: Part
2: Acoustic Characteristics of Joint Sounds,'' Journal of the Nihon
University School of Dentistry, 137: 47-54, 1995.
26. Sadowsky, C., T. A. Thelsen, and E. I. Sakois, ``Orthodontic
Treatment and Temporomandibular Joint Sounds--A Longitudinal
Study,'' American Journal of Orthodontic and Dentofacial
Orthopedics, 99: 441-447, 1991.
27. Dos Santos, Jose, ``Supportive Conservative Therapies for
Temporomandibular Disorders,'' Dental Clinics of North America, 39:
459-477, 1995.
28. Shields, J. M., J. A. Clayton, and L. D. Sindledecker, Using
Pantographic Tracings to Detect TMJ and Muscle Dysfunctions,'' The
Journal of Prosthetic Dentistry, 39: 80-91, 1978.
29. Tallenta, R. H., J. Catania and E. Sommers,
``Temporomandibular Joint Findings in Pediatric Populations and
Young Adults: A Critical Review,'' The Angle Orthodontist, 61: 7-16,
1991.
30. Tripodakis, A. P., J. B. Smulow, N. R. Mehta and R. E.
Clark, ``Clinical Study of Location and Reproducibility of Three
Mandibular Positions in Relation to Body Posture and Muscle
Function,'' The Journal of Prosthetic Dentistry, 73: 190-198, 1995.
31. Tsolka, P. and H. W. Preiskel, ``Kinesiographic and
Electromyographic Assessment of the Effects of Occlusal Adjustment
Therapy on Craniomandibular Disorders by a Double-Blind Method,''
The Journal of Prosthetic Dentistry, 69: 85-92, 1993.
32. Wabeke, K. B., R. J. Spruijt, and L. L. M. H. Habets,
``Spatial and Morphologic Aspects of Temporomandibular Joints With
Sounds,'' Journal of Oral Rehabilitation, 22: 21-27, 1995.
33. Widmer, C., ``Temporomandibular Joint Sounds: A Critique of
Techniques for Recording and Analysis,'' Journal of Craniomandibular
Disorders: Facial & Oral Pain, 3: 213-217, 1989.
34. Management of Temporomandibular Disorders, National
Institutes of Health Technology Assessment Conference Statement,
April 29-May 1, pp. 1-31, 1996.
List of Subjects in 21 CFR Part 872
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, FDA is
proposing to amend 21 CFR part 872 as follows:
PART 872--DENTAL DEVICES
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.
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.
(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; Guidance for Industry and FDA Reviewers.''
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 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.
(b) Jaw tracking device for interpretation of temporomandibular
joint position for the diagnosis of temporomandibular joint disorders
and associated orofacial pain--(1) Identification. A jaw tracking
device for interpretation of temporomandibular joint position 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; Guidance for Industry and FDA Reviewers.''
Dated: August 1, 2002.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-20499 Filed 8-13-02; 8:45 am]
BILLING CODE 4160-01-S