[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Register, FDA is publishing a notice of availability of a draft 
guidance document that would serve as the special control for the class 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