94-31161. Medical Devices; Classification of Temporomandibular Joint Implants  

  • [Federal Register Volume 59, Number 243 (Tuesday, December 20, 1994)]
    [Unknown Section]
    [Page 0]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 94-31161]
    
    
    [[Page Unknown]]
    
    [Federal Register: December 20, 1994]
    
    
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    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    
    Food and Drug Administration
    
    21 CFR Part 872
    
    [Docket No. 92N-0281]
    
     
    
    Medical Devices; Classification of Temporomandibular Joint 
    Implants
    
    AGENCY: Food and Drug Administration, HHS.
    
    ACTION: Final rule.
    
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    SUMMARY: The Food and Drug Administration (FDA) is classifying four 
    temporomandibular joint (TMJ) implants, the total temporomandibular 
    joint prosthesis, the glenoid fossa prosthesis, the mandibular condyle 
    prosthesis, and the interarticular disc prosthesis (interpositional 
    implant), into class III (premarket approval). These actions are being 
    taken under the Federal Food, Drug, and Cosmetic Act (the act), as 
    amended by the Medical Device Amendments of 1976 (the 1976 amendments) 
    and the Safe Medical Devices Act of 1990 (the SMDA).
    
    EFFECTIVE DATE: January 19, 1995.
    
    FOR FURTHER INFORMATION CONTACT: Joseph M. Sheehan, Center for Devices 
    and Radiological Health (HFZ-84), Food and Drug Administration, 2098 
    Gaither Rd., Rockville, MD 20850, 301-594-4765, ext. 157.
    
    SUPPLEMENTARY INFORMATION:
    
    I. Background
    
        In the Federal Register of September 18, 1992 (57 FR 43165), FDA 
    issued a proposed rule to classify certain TMJ implants into class III. 
    Initially, FDA provided for interested persons to submit written 
    comments on the proposal by November 17, 1992. In response to a request 
    for an extension of the comment period, in the Federal Register of 
    December 1, 1992 (57 FR 56876), FDA extended the comment period until 
    December 8, 1992.
        Subsequently, in the Federal Register of February 14, 1994 (59 FR 
    6935), FDA reproposed to classify two TMJ implants, the mandibular 
    condyle prosthesis and the glenoid fossa prosthesis, into class III 
    (premarket approval) to reflect the recommendation of the Dental 
    Products Panel (the panel) with respect to the classification of these 
    devices.
    
    II. Response to Comments
    
        The agency received 54 comments responding to the proposed rule and 
    one comment responding to the reproposed rule. These comments were 
    submitted by a law firm, oral and maxillofacial surgeons who placed TMJ 
    implants, manufacturers and distributors of TMJ implants, and TMJ 
    implant recipients.
        1. In the preamble to the proposed rule, FDA advised interested 
    persons that the agency lacked evidence that the total TMJ prosthesis 
    was legally in commercial distribution before May 28, 1976. If the 
    device was first introduced into interstate commerce after May 28, 
    1976, it would be in class III in accordance with section 513 of the 
    act (21 U.S.C. 360c). FDA specifically requested comments on this 
    issue. In response, FDA received several comments stating that the 
    total TMJ prosthesis was legally in commercial distribution in the 
    United States before May 28, 1976, and one comment to the contrary.
        FDA has determined, from information submitted in comments, that 
    two firms, TMJ Implants, Inc., Golden, CO, and the Temporomandibular 
    Joint Research Foundation, La Cresenta, CA, were commercially 
    distributing the total TMJ prosthesis in the United States on or before 
    May 28, 1976. Thus, the agency has concluded that the total TMJ 
    prosthesis is, in fact, a preamendments device and should be classified 
    along with the other TMJ implants.
        2. Several comments stated that classification of TMJ implants into 
    class III (premarket approval) might result in the unavailability of 
    these devices for clinical use or in a movement to ban them. One 
    manufacturer of total TMJ implants stated that, if the total TMJ 
    implant is classified into class III, the expense of preparing a PMA 
    would force that manufacturer to discontinue marketing the device.
        Under the statute, FDA classifies a device into class III, and 
    subsequently requires submission of PMA's for the device, when FDA has 
    determined that premarket approval is necessary to provide reasonable 
    assurance of the safety and effectiveness of the device. The 
    classification of a device, therefore, is based on considerations 
    related to the safety or effectiveness of the device.
        FDA disagrees that classifying TMJ implants into class III will 
    necessarily result in the unavailability and/or the banning of these 
    devices because of the procedural safeguards contained in the statute. 
    The effect of classifying a device into class III is to provide each 
    manufacturer of the device with sufficient time to conduct necessary 
    testing of the device (a minimum of 30 months) and then to submit a PMA 
    to FDA by a date to be set in a future regulation under section 515(b) 
    of the act (21 U.S.C. 360e(b)(1)). That regulation is promulgated using 
    notice-and-comment rulemaking, in conjunction with which manufacturers 
    are permitted to petition for reclassification. Moreover, pursuant to 
    section 501(f) of the act (21 U.S.C. 351(f)(1)), a preamendments device 
    may continue to be sold throughout this time period and while a PMA is 
    pending.
        FDA is not attempting to ban TMJ implants by classifying them into 
    class III. In fact, by eventually requiring submission of PMA's for 
    these devices, FDA will be giving manufacturers the opportunity to 
    establish that the devices are safe and effective. The classification 
    of a device into class III neither results in nor is it related to the 
    banning of a device under section 516 of the act (21 U.S.C. 360f).
        3. Several comments stated that, for reconstruction of the 
    temporomandibular joint, non-ProplastTM TMJ implant devices are 
    superior to autogenous materials. One comment stated that partial fossa 
    protheses are safe and effective. Comments from patients and TMJ 
    prostheses manufacturers stated that they experienced favorable results 
    following implantation of the total TMJ prosthesis.
        In classifying these devices, FDA is determining the level of 
    regulatory control needed to provide reasonable assurance of their 
    safety and effectiveness. Whether non-ProplastTM TMJ implants are 
    superior in safety and effectiveness to autogenous materials, or 
    whether partial fossa prostheses are perceived as safe and effective, 
    is not relevant to this determination.
        In accordance with section 513(a)(3) of the act, the agency relies 
    on valid scientific evidence to determine the classification of a 
    device. According to Sec. 860.7(c)(2) (21 CFR 860.7(c)(2)), valid 
    scientific evidence includes evidence from well-controlled 
    investigations, partially controlled studies, studies and objective 
    trials without matched controls, well-documented case histories 
    conducted by qualified experts, and reports of significant human 
    experience with a marketed device. Valid scientific evidence does not 
    include isolated case reports, random experience, reports lacking 
    sufficient details to permit scientific evaluation, or unsubstantiated 
    opinions. Thus, the isolated case reports, random testimonials, and 
    unsubstantiated opinions received in response to the proposed rule 
    cannot be regarded as valid scientific evidence upon which the 
    classification of TMJ implants can be based.
        4. One comment stated that the agency's failure to provide the 
    panel information relating to TMJ devices made of materials other than 
    ProplastTM limited the panel's consideration and should limit the 
    scope of its classification recommendation accordingly.
        FDA disagrees with this comment. As stated in the legislative 
    history of the Medical Device Amendments of 1976:
        In requiring a panel's classification recommendation to include 
    a summary of the reasons for the recommendation and a summary of the 
    data upon which the recommendation is based, the objective is to 
    assure that the record accurately reflects the basis for the panel's 
    recommendations. The use of the term ``data'' is not intended to 
    refer only to the results of scientific experiments but should also 
    consist of less formal evidence, other scientific information, or 
    judgments of experts when available. The requirement is not intended 
    to imply that a panel must have received evidence with respect to 
    safety and effectiveness of a device before it can make a 
    classification recommendation. Under this premise, the burden of 
    providing evidence substantiating the safety and effectiveness of a 
    device rests on the manufacturers, and the absence of sufficient 
    data may be referred to in a panel's recommendation as the reason 
    for classification of a device into class III.
        (See H. Rept. No. 94-853, 94th Cong., 2d sess. 40 (1976), p. 40).
        5. One comment asserted that the references cited by FDA in the 
    proposed rule classifying the total TMJ implant did not exist at the 
    time of the panel meeting and, therefore, could not have been evaluated 
    by the panel when making its recommendation.
        FDA disagrees with this comment. It is true that some of the 
    information cited by FDA in support of its proposed classification of 
    the total TMJ implant did not exist at the time of the panel's April 
    21, 1989, meeting. However, the proposed rule reflected not only the 
    panel's recommendations, but also FDA's determinations regarding the 
    proper classification of these devices. The proposed rule did not state 
    or imply that the panel relied on all the data cited by the agency in 
    support of the proposed rule.
        6. Several comments suggested that, when classifying these devices, 
    FDA should distinguish TMJ prostheses containing ProplastTM from 
    those not containing that material. These comments recommended that 
    only devices containing ProplastTM should be classified. Some 
    comments stated that the risks to health identified in the proposed 
    rule are based only on data associated with the failure of TMJ 
    prostheses containing ProplastTM. One comment stated that 
    ProplastTM implants and non-ProplastTM implants (specifically 
    cobalt chrome and polymethylmethacrylate (PMMA) prostheses) should be 
    classified separately because the difference in the material used in 
    these implants significantly affects their safety and effectiveness. 
    Several comments stated that surgeons and TMJ implant manufacturers had 
    observed no specific cases of the risks to health identified in the 
    proposed rule in several patients implanted with a non-ProplastTM 
    total TMJ prosthesis. Some comments stated that these risks to health 
    were not observed in patients implanted with TMJ prostheses 
    manufactured by specific manufacturers. In contrast, several comments 
    said that these risks were observed often in patients implanted with 
    TMJ implants containing ProplastTM.
        According to Sec. 860.5(c)(3), when FDA initially classifies a 
    device, it may consider safety and effectiveness data developed for 
    other devices of the same generic type. A generic type of device 
    includes devices that do not differ significantly in purpose, design, 
    material, energy source, function, or any other feature related to 
    safety and effectiveness, and for which similar regulatory controls are 
    sufficient to provide reasonable assurance of safety and effectiveness 
    (see Sec. 860.3(i)).
        The transcript of the April 21, 1989, panel meeting demonstrates 
    that the panel considered TMJ implants composed of various materials, 
    i.e., silicone, ProplastTM, dural grafts, fascia, vitallium, 
    acrylic, meniscle and silastic, before making its recommendations with 
    respect to classification. Evidence submitted during the panel meeting 
    revealed that similar risks and similar safety and effectiveness 
    concerns are associated with all TMJ implants, regardless of material 
    composition. Based on the evidence provided, the panel concluded that 
    TMJ devices composed of different materials raise the same safety and 
    effectiveness questions. Thus, the panel concluded, and FDA agrees, 
    that TMJ implants of all materials should be regulated within the four 
    generic types of devices identified because the devices do not differ 
    significantly in the safety and effectiveness questions raised and, 
    consequently, similar regulatory controls will be needed to provide 
    reasonable assurance of their safety and effectiveness.
        7. Comments stated that one of the health risks identified in the 
    proposed rule, loosening of the total TMJ prosthesis, is directly 
    related to the health of the bone at the implant interface. These 
    comments asserted that loosening of the device does not occur unless 
    there is a void of suitable bone.
        As stated in the preamble to the proposed rule, FDA has determined 
    that the screws used to anchor the implant may loosen, resulting in 
    implant loosening or displacement which may cause changes in bite, 
    difficulty in chewing, limited joint function and unpredictable wear on 
    implant components (see Refs. 2 through 5). The agency has not received 
    any new information to cause FDA to change its opinion.
        8. Some comments asserted that FDA should classify all the TMJ 
    implants into class II because special controls would allow the agency 
    to impose special conditions on these devices, such as postmarket 
    surveillance. One of these comments, received from a TMJ implant 
    manufacturer, recommended that FDA classify TMJ cobalt-chrome-PMMA 
    implants into class II.
        FDA disagrees with these comments. FDA believes that insufficient 
    information exists to establish that special controls would provide 
    reasonable assurance of the safety and effectiveness of these devices. 
    FDA believes that a PMA is necessary to provide such assurance. 
    Furthermore, postmarket surveillance is not limited to class II 
    devices. Thus, at some future time, FDA may request that manufacturers 
    of TMJ implants conduct postmarket surveillance of these devices.
        9. One comment urged that the total temporomandibular joint 
    prosthesis and the interarticular implant be given high priority in 
    calling for PMA's. One comment disagreed, stating that FDA cannot give 
    the total TMJ prosthesis high priority in calling for PMA's when the 
    panel recommended low priority. Another comment expressed concern that 
    manufacturers of these prostheses will not have to submit PMA's to FDA 
    for at least 2\1/2\ years and will be permitted to market the devices 
    in the interim.
        Pursuant to sections 501(f) and 515(b) of the act, TMJ implant 
    manufacturers may continue to commercially distribute their devices 
    without filing a PMA for 30 months after the effective date of the 
    final rule classifying these implants into class III or until 90 days 
    after FDA issues a final rule requiring premarket approval for the 
    devices, whichever is later. Moreover, section 515(i) of the act shows 
    a clear congressional intent that FDA move forward with requiring the 
    submission of PMA's for all preamendments devices. Thus, regardless of 
    the priority assigned for calling for PMA's, eventually PMA's will be 
    required for all class III preamendments devices that are not 
    reclassified. Furthermore, it should be noted that a panel 
    recommendation is only a recommendation that FDA may adopt or reject. 
    FDA believes that it is appropriate to require PMA's for all TMJ 
    implants as soon as possible under the act.
        10. Two comments objected that the glenoid fossa prosthesis and the 
    mandibular condyle prosthesis should not be classified into class III 
    because the panel did not recommend that they be classified into class 
    III.
        Subsequent to issuing the proposed rule, the panel reconvened on 
    February 11, 1993, and recommended that the mandibular condyle 
    prosthesis and the glenoid fossa prosthesis be classified into class 
    III. Based on this recommendation, FDA issued a reproposed rule in the 
    Federal Register of February 14, 1994 (59 FR 6935), to classify the 
    devices into class III.
        11. One comment stated that the classification process for the TMJ 
    implants was flawed and should be reinitiated because of events which 
    transpired between the April 1989 panel recommendation and the issuance 
    of the proposed rule. During this time, the SMDA was passed. Among 
    other things, the SMDA changed the classification definitions for 
    medical devices.
        FDA disagrees with this comment. It is the agency's position that 
    the SMDA does not require the agency to obtain a new classification 
    recommendation from a panel which had recommended classification under 
    the previous standard.
        As stated previously, the agency is not bound to adopt a panel's 
    recommendation. Moreover, in light of the significant risks to health 
    identified by the panel, FDA believes it is extremely unlikely that the 
    panel would have recommended that the devices be classified into class 
    II under the new definition.
        12. On its own initiative, FDA has deleted the words, ``naturally 
    occurring'' from the identifications of glenoid fossa prosthesis and 
    mandibular condyle prosthesis because the standard of care now 
    indicates that these devices may now interface not only with naturally 
    occurring surfaces but also with artificial surfaces.
    
    III. References
    
        The following referencees have been placed on display in the 
    Dockets Management Branch (address above) and may be seen by interested 
    persons between 9 a.m. and 4 p.m., Monday through Friday.
        1. Transcripts of the Dental Products Panel meeting, April 21, 
    1989.
        2. Transcripts of the Dental Products Panel meeting, February 
    11, 1993.
        3. Fontenot, M. G., and J. N. Kent, ``In-vitro and In-Vivo Wear 
    Performance of TMJ Implants,'' abstract, International Association 
    of Dental Research, 1991.
        4. Kent, J. N., and M. S. Block, ``Comparison of FEP and UPE 
    Glenoid Fossa Prosthesis,'' abstract, International Association of 
    Dental Research, 1991.
        5. ``Clinical Information on the Vitek TMJ Interpositional (IPI) 
    Implant and the Vitek-Kent (VK) and Vitek-Kent 1 (VK-1) TMJ 
    Implants,'' and ``Vitek Patient Notification Program,'' an FDA 
    publication, 1991.
        6. Kent, J. N., ``VK Partial and Total Joint Reconstruction,'' 
    Current Concepts of TMJ Total Joint Replacement, University of 
    Medicine and Dentistry of New Jersey, pp. 1-8, March 1992.
        7. Primely, D., Jr., ``Histological and Radiological Evaluation 
    of the ProplastTM-Teflon Interpositional Implant in 
    Temporomandibular Joint Reconstruction Following Meniscectomy,'' 
    thesis, Master Degree in Oral Maxillofacial Surgery, University of 
    Iowa, May 1987.
        8. Westlund, K. J., ``An Evaluation Using Computerized 
    Tomography of Clinically Asymptomatic Patients Following 
    Meniscectomy and Temporomandibular Joint Reconstruction Using the 
    ProplastTM-Teflon Interpositional Implant,'' thesis, Masters 
    Degree in Oral and Maxillofacial Surgery, University of Iowa,May 
    1989.
        9. Wagner, J. D., and E. L. Mosby, ``Assessment of 
    ProplastTM-Teflon Disc Replacements,'' Journal of Oral and 
    Maxillofacial Surgery, 48:1140-1144, 1990.
        10. Florine, B. K., et al., ``Tomographic Evaluation of 
    Temporomandibular Joints Following Discoplasty or Placement of 
    Polytetrafluoroethylene Implants,'' Journal of Oral and 
    Maxillofacial Surgery, 48:183-188, 1988.
        11. Heffez, L., et al., ``CT Evaluation of TMJ Disc Replacement 
    with a ProplastTM Teflon Laminate,'' Journal of Oral and 
    Maxillofacial Surgery, 45:657-665, 1987.
        12. Ryan, D. E., ``Alloplastic Implants in the Temporomandibular 
    Joint,'' Oral and Maxillofacial Surgery Clinics of North America, 
    1:427, 1989.
        13. Valentine, J. D., ``Light and Electron Microscopic 
    Evaluation of ProplastTM II TMJ Disc Implants,'' Journal of 
    Oral and Maxillofacial Surgery, 47:689-696, 1989.
        14. Logrotteria, L., et. al., ``Patient with Lymphadenopathy 
    Following Temporomandibular Joint Arthroplasty with 
    ProplastTM,'' The Hour of Craniomandibular Practice, vol. 4, 
    No. 2:172-178, 1986.
        15. Berarduci, J. P., et al., ``Perforation into Middle Cranial 
    Fossa as a Sequel to Use of a ProplastTM-Teflon Implant for 
    Temporomandibular Joint Reconstruction,'' Journal of Oral and 
    Maxillofacial Surgery, 46:496-498, 1990.
        16. Berman, D. N., and S. L. Pronstein, ``Osteo Phytic Reaction 
    to a Polytetrafluoroethylene Temporomandibular Joint Implant,'' Oral 
    Surgery, Oral Medicine, Oral Pathology (continues the Oral Surgery 
    Section of the American Journal of Orthodontics and Oral Surgery), 
    69:20-23, 1990.
    
    IV. Environmental Imapct
    
        The agency has determined under 21 CFR 25.24(e)(2) 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.
    
    V. Analysis of Impacts
    
        FDA has examined the impacts of the final rule under Executive 
    Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-54). 
    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 final rule is consistent with the regulatory philosophy and 
    principles identified in the Executive Order. In addition, the final 
    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. Because this rule does not impose any new 
    requirements, the agency certifies that the final rule will not have a 
    significant economic impact on a substantial number of small entities. 
    Therefore, under the Regulatory Flexibility Act, no further analysis is 
    required.
    
    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, 21 CFR 
    part 872 is amended as follows:
    
    PART 872--DENTAL DEVICES
    
        1. The authority citation for 21 CFR part 872 continues to read as 
    follows:
    
        Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal 
    Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j, 
    371).
    
        2. New Secs. 872.3940, 872.3950, 872.3960, and 872.3970 are added 
    to subpart D to read as follows:
    
    Sec. 872.3940  Total temporomandibular joint prosthesis.
    
        (a) Identification. A total temporomandibular joint prosthesis is a 
    device that is intended to be implanted in the human jaw to replace the 
    mandibular condyle and augment the glenoid fossa to functionally 
    reconstruct the temporomandibular joint.
        (b) Classification. Class III.
        (c) Date PMA or notice of completion of a PDP is required. The 
    effective date of the requirement for premarket approval has not been 
    established. See Sec. 872.3.
    
    Sec. 872.3950  Glenoid fossa prosthesis.
    
        (a) Identification. A glenoid fossa prosthesis is a device that is 
    intended to be implanted in the temporomandibular joint to augment a 
    glenoid fossa or to provide an articulation surface for the head of a 
    mandibular condyle.
        (b) Classification. Class III.
        (c) Date PMA or notice of completion of a PDP is required. The 
    effective date of the requirement for premarket approval has not been 
    established. See Sec. 872.3.
    
    Sec. 872.3960  Mandibular condyle prosthesis.
    
        (a) Identification. A mandibular condyle prosthesis is a device 
    that is intended to be implanted in the human jaw to replace the 
    mandibular condyle and to articulate within a glenoid fossa.
        (b) Classification. Class III.
        (c) Date PMA or notice of completion of a PDP is required. The 
    effective date of the requirement for premarket approval has not been 
    established. See Sec. 872.3.
    
    
    Sec. 872.3970  Interarticular disc prosthesis (interpositional 
    implant).
    
        (a) Identification. An interarticular disc prosthesis 
    (interpositional implant) is a device that is intended to be an 
    interface between the natural articulating surface of the mandibular 
    condyle and glenoid fossa.
        (b) Classification. Class III.
        (c) Date PMA or notice of completion of a PDP is required. The 
    effective date of the requirement for premarket approval hasnot been 
    established. See Sec. 872.3.
    
        Dated: November 25, 1994.
    D. B. Burlington,
    Director, Center for Devices and Radiological Health.
    [FR Doc. 94-31161 Filed 12-19-94; 8:45 am]
    BILLING CODE 4160-01-F
    
    
    

Document Information

Published:
12/20/1994
Department:
Food and Drug Administration
Entry Type:
Uncategorized Document
Action:
Final rule.
Document Number:
94-31161
Dates:
January 19, 1995.
Pages:
0-0 (1 pages)
Docket Numbers:
Federal Register: December 20, 1994, Docket No. 92N-0281
CFR: (4)
21 CFR 872.3940
21 CFR 872.3950
21 CFR 872.3960
21 CFR 872.3970