[Federal Register Volume 59, Number 30 (Monday, February 14, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-3399]


[[Page Unknown]]

[Federal Register: February 14, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 872

[Docket No. 93N-0470]

 

Medical Devices; Classification of Temporomandibular Joint 
Implants

AGENCY: Food and Drug Administration, HHS.

ACTION: Reproposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is reproposing to 
classify two temporomandibular joint (TMJ) implants, the Mandibular 
Condyle Prosthesis and the Glenoid Fossa Prosthesis, into class III 
(premarket approval). The agency is issuing this reproposal to reflect 
the recommendation of the Dental Products Panel with respect to the 
classification of these devices. All comments received on the original 
proposal remain part of the record for this proposal. 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 amendments) 
and the Safe Medical Devices Act of 1990 (the SMDA).

DATES: Written comments by April 15, 1994. The Commissioner of Food and 
Drugs proposes that the final regulation based on this proposal become 
effective 30 days after the date of its publication in the Federal 
Register.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Joseph M. Sheehan, Center for Devices 
and Radiological Health (HFZ-84), Food and Drug Administration, 2094 
Gaither Rd., Rockville, MD 20850, 301-594-4765.

SUPPLEMENTARY INFORMATION:

I. Background

    The act, as amended by the amendments (Pub. L. 94-295) and the SMDA 
(Pub. L. 101-629), 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.
    Devices that were in commercial distribution before May 28, 1976 
(the amendments) are classified under section 513 of the act after FDA 
has done the following: (1) Received a recommendation from a device 
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. A device that is first offered in commercial 
distribution after May 28, 1976, and is substantially equivalent to a 
device classified under this scheme, is also classified into the same 
class as the device to which it is substantially equivalent.
    A device that was not in commercial distribution prior to May 28, 
1976, and that is not substantially equivalent to a preamendments 
device, is classified by statute into class III without any FDA 
rulemaking proceedings. The agency determines whether new devices are 
substantially equivalent to previously offered devices by means of the 
premarket notification procedure in section 510(k) of the act (21 
U.S.C. 360(k)) and part 807 of the regulations (21 CFR part 807).
    Based upon the recommendations of FDA's Dental Device 
Classification Panel, the agency published a final regulation 
classifying 110 preamendments dental devices on August 12, 1987 (52 FR 
30082). The TMJ prostheses were inadvertently omitted from the dental 
devices considered for reclassification by the panel and the agency. 
Based upon the recommendations of the Dental Products Panel, following 
its April 21, 1989 meeting, FDA proposed on September 18, 1992 (57 FR 
43165), to classify the Interarticular Disc Prosthesis, the Mandibular 
Condyle Prosthesis, the Glenoid Fossa Prosthesis, and the Total 
Temporomandibular Prosthesis into class III.
    At the April 1989 meeting of the Dental Products Panel, the Panel 
did not make a recommendation regarding the classification of the 
glenoid fossa prosthesis or the mandibular condyle prosthesis. The 
Panel noted, however, that an implanted glenoid fossa should not be 
used with a naturally occurring mandibular condyle, and an implanted 
mandibular condyle should not be used with a naturally occurring 
glenoid fossa. At the February 11, 1993 meeting, the Dental Products 
Panel recommended that the mandibular condyle prosthesis and the 
glenoid fossa prosthesis be classified into class III. Based upon these 
recommendations, FDA is reproposing the classification of these two 
devices into class III.
    The effect of classifying a device into class III is to require 
each manufacturer of the device to submit to FDA a premarket approval 
application (PMA) by a date to be set in a future regulation under 
section 515(b) of the act (21 U.S.C. 360e(b)). Each application must 
include sufficient valid scientific evidence to provide reasonable 
assurance that the device is safe and effective under the conditions of 
use prescribed, recommended, or suggested in its proposed labeling. 
PMA's for class III preamendments devices must be submitted within 30 
months after final classification, or 90 days after the agency 
publishes a final regulation under 21 U.S.C. 360e(b) requiring PMA's 
for the device, whichever is later.
    FDA advises manufacturers of the devices being classified that, if 
the devices are classified into class III, the agency intends to 
require PMA's to be filed for these devices at the earliest date 
allowed under the statute. Therefore, PMA's (or approved 
investigational device exemptions) would be required for these devices 
on the last day of the 30th month following final classification into 
class III.

II. The Dental Products Panel Recommendations

A.  Glenoid Fossa Prosthesis

    The Dental Products Panel, an FDA advisory committee, made the 
following recommendation regarding the classification of the glenoid 
fossa prosthesis:
    1.  Identification: A glenoid fossa prosthesis is a device that is 
intended to be implanted in the temporomandibular joint to augment a 
glenoid fossa, and provide an articulation surface for the head of a 
naturally occurring mandibular condyle.
    2.  Recommended classification:  Class III (premarket approval). 
The Dental Products Panel recommended that premarket approval of the 
glenoid fossa prosthesis be high priority.
    3.  Summary of reasons for recommendation: The Dental Products 
Panel recommended that the glenoid fossa prosthesis be classified into 
class III because the Panel believed that premarket approval is 
necessary to provide reasonable assurance of the safety and 
effectiveness of the device. The Panel also believed that the device 
presents a potential unreasonable risk of illness or injury to the 
patient and that insufficient information exists to determine that 
general controls, either alone or in combination with the special 
controls applicable to class II devices, are sufficient to provide 
reasonable assurance of the safety and effectiveness of the device. 
Therefore, the device should be subject to premarket approval to ensure 
that each manufacturer of this device develop sufficient information to 
provide reasonable assurance that it is safe and effective.
    4.  Summary of data on which the recommendation is based:  The 
Dental Products Panel based its recommendation on the Panel members' 
personal knowledge of, and clinical experience with, the device and 
presentations by Panel members and interested parties (Ref. 1).
    5.  Risks to health: The following risks are associated with the 
glenoid fossa prosthesis: (a) Implant loosening or displacement. The 
screws used to anchor the implant may loosen, resulting in implant 
loosening or displacement causing changes in bite, difficulty in 
chewing, limited joint function, and unpredictable wear on implant 
components (Refs. 2 through 5); (b) Degenerative changes to the natural 
articulating surfaces. Implant breakdown may result in erosion or 
resorption of the head of the mandibular condyle or the glenoid fossa. 
The erosion or resorption may result in intense pain, changes in bite, 
difficulty in chewing, limited joint function, and perforation into the 
middle cranial fossa (Refs. 2 through 5); (c) Foreign body reaction. 
Implant deterioration and migration may result in a foreign body 
reaction characterized by multinucleated giant cells (Refs. 2 through 
5); (d) Infection. If the implant cannot be properly sterilized, 
infection may result; (e) Loss of implant integrity. If the implant 
materials are unable to withstand mechanical loading, the implant can 
be torn, perforated, delaminated, fragmented, fatigued, or fractured, 
resulting in failure of the device to function properly (Refs. 2 
through 5); (f) Corrosion. If the implant materials are subject to 
corrosion, toxic elements may migrate to various parts of the body; (g) 
Chronic pain. Degenerative changes within the articular surfaces and 
components of the temporomandibular joint due to implant breakdown may 
result in chronic pain (Refs. 2 through 5); (h) Changes to the 
contralateral joint. Unilateral placement of the implant may result in 
deleterious effects to the contralateral joint; and (i) Malocclusion. 
Placement of the device may produce an improper occlusal relationship.
    FDA agrees with the Dental Products Panel's classification 
recommendation and is proposing that the glenoid fossa prosthesis be 
classified into class III (premarket approval). FDA believes that 
insufficient information exists to identify the proper materials or 
design for the glenoid fossa prosthesis. Therefore, FDA is proposing 
that premarket approval of the glenoid fossa prosthesis be given high 
priority.
    The act requires the agency to classify into class III a device 
that presents a potential unreasonable risk of illness or injury unless 
it determines that premarket approval is not necessary to provide 
reasonable assurance of the safety and effectiveness of the device. FDA 
believes that the device presents a potential unreasonable risk of 
illness or injury to the patient if there are not adequate data to 
ensure the safe and effective use of the device. The agency believes 
that general controls, either alone or in combination with the special 
controls applicable to class II devices, are insufficient to provide 
reasonable assurance of safety and effectiveness of the device.

B.  Mandibular Condyle Prosthesis

    The Dental Products Panel, an FDA advisory committee, made the 
following recommendations regarding the classification of the 
mandibular condyle prosthesis:
    1.  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 naturally occurring 
glenoid fossa.
    2.  Recommended classification:  Class III (premarket approval). 
The Dental Products Panel recommended that premarket approval of the 
mandibular condyle prosthesis be high priority.
    3. Summary of reasons for recommendation:  The Dental Products 
Panel recommended that the mandibular condyle prosthesis be classified 
into class III because the Panel believed that premarket approval is 
necessary to provide reasonable assurance of the safety and 
effectiveness of the device. The Panel also believed that the device 
presents a potential unreasonable risk of illness or injury to the 
patient and that insufficient information exists to determine that 
general controls, either alone or in combination with the special 
controls applicable to class II devices, are sufficient to provide 
reasonable assurance of the safety and effectiveness of the device. 
Therefore, the device should be subject to premarket approval to ensure 
that each manufacturer of this device develop sufficient information to 
provide reasonable assurance that it is safe and effective.
    4.  Summary of data on which the recommendation is based:  The 
Dental Products Panel based its recommendation on the Panel members' 
personal knowledge of, and clinical experience with, the device and 
presentations by Panel members and interested parties (Ref. 1).
    5.  Risks to health: The following risks are associated with the 
mandibular condyle prosthesis: (a) Implant loosening or displacement. 
The screws used to anchor the implant may loosen, resulting in implant 
loosening or displacement causing changes in bite, difficulty in 
chewing, limited joint function and unpredictable wear on implant 
components (Refs. 2 through 5); (b) Degenerative changes to the natural 
articulating surfaces. Implant breakdown may result in erosion or 
resorption of the head of the mandibular condyle or the glenoid fossa. 
The erosion or resorption may result in intense pain, changes in bite, 
difficulty in chewing, limited joint function, and perforation into the 
middle cranial fossa (Refs. 2 through 5); (c) Foreign body reaction. 
Implant deterioration and migration may result in a foreign body 
reaction characterized by multinucleated giant cells (Refs. 2 through 
5); (d) Infection. If the implant cannot be properly sterilized, 
infection may result; (e) Loss of implant integrity. If the implant 
materials are unable to withstand mechanical loading, the implant can 
be torn, perforated, delaminated, fragmented, fatigued, or fractured, 
resulting in failure of the device to function properly (Refs. 2 
through 5); (f) Corrosion. If the implant materials are subject to 
corrosion, toxic elements may migrate to various parts of the body; (g) 
Chronic pain. Degenerative changes within the articular surfaces and 
components of the temporomandibular joint due to implant breakdown may 
result in chronic pain (Refs. 2 through 5); (h) Changes to the 
contralateral joint. Unilateral placement of the implant may result in 
deleterious effects to the contralateral joint; and (i) Malocclusion. 
Placement of the device may produce an improper occlusal relationship.
    FDA agrees with the Dental Products Panel's classification 
recommendation and is proposing that the mandibular condyle prosthesis 
be classified into class III (premarket approval). FDA believes that 
insufficient information exists to identify the proper materials or 
design for the mandibular condyle prosthesis. Therefore, FDA is 
proposing that premarket approval of the mandibular condyle prosthesis 
be given high priority.
    The act requires the agency to classify into class III a device 
that presents a potential unreasonable risk of illness or injury unless 
it determines that premarket approval is not necessary to provide 
reasonable assurance of the safety and effectiveness of the device. FDA 
believes that the device presents a potential unreasonable risk of 
illness or injury to the patient if there are not adequate data to 
ensure the safe and effective use of the device. The agency believes 
that general controls, either alone or in combination with the special 
controls applicable to class II devices, are insufficient to provide 
reasonable assurance of safety and effectiveness of the device.

III. References

    The following references 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, February 
11, 1993.
    2. Fontenot, M. G., and J. K. Kent, ``In-Vitro and In-Vivo Wear 
Performance of TMJ Implants,'' abstract, International Association 
of Dental Research, 1991.
    3. Kent, J. N., and M. S. Block, ``Comparison of FEP and UPE 
Glenoid Fossa Prosthesis,'' abstract, International Association of 
Dental Research, 1991.
    4. ``Clinical Information on the Vitek TMJ Interpositional (IPI) 
Implant and the Vitek-Kent (VK) and Vitek-Kent 1 (VK-1) TMJ 
Implants'' in ``Vitek Patient Notification Program,'' FDA 
Publication, 1991.
    5. 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.

IV. Environmental Impact

    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. Economic Impact

    FDA has examined the costs and benefits of this proposed rule to 
classify two TMJ implants into class III in accordance with Executive 
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354). The 
proposed rule would not impose any new requirements. Therefore, FDA 
concludes that the proposed rule is not a significant rule as defined 
by Executive Order 12866. In accordance with the Regulatory Flexibility 
Act, the agency certifies that the proposed rule will not have a 
significant impact on a substantial number of small businesses.

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, it is 
proposed that 21 CFR part 872 be 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. 872.3950 and 872.3960 are added to subpart D to read 
as follows:


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, and provide an articulation surface for the head of a 
naturally occurring 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 the 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 naturally occurring 
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 the premarket approval has not 
been established. See Sec. 872.3.

    Dated: February 8, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-3399 Filed 2-11-94; 8:45 am]
BILLING CODE 4160-01-F