[Federal Register Volume 63, Number 250 (Wednesday, December 30, 1998)]
[Rules and Regulations]
[Pages 71743-71746]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-34483]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 872

[Docket No. 97N-0239]


Dental Devices; Effective Date of Requirement for Premarket 
Approval; Temporomandibular Joint Prostheses

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Final rule.

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SUMMARY:  The Food and Drug Administration (FDA) is issuing a final 
rule to require the filing of a premarket approval application (PMA) or 
a notice of completion of a product development protocol (PDP) for 
certain devices, namely, the total temporomandibular joint (TMJ) 
prosthesis, the glenoid fossa prosthesis, the mandibular condyle 
prosthesis (for permanent reconstruction), and the interarticular disc 
prosthesis. At a later date, FDA will propose reclassifying from class 
III into class II the generic type of temporary mandibular condyle 
prosthesis intended for temporary reconstruction following surgical 
ablation of malignant and benign tumors. This action establishing the 
effective date of the premarket approval requirement for certain 
devices is being taken under the Federal Food, Drug, and Cosmetic Act 
(the act), as amended by the Medical Device Amendments of 1976 (the 
1976 amendments), the Safe Medical Devices Act of 1990 (the SMDA), and 
the FDA Modernization Act of 1997 (FDAMA).

DATES: This regulation is effective December 30, 1998.

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

A. Regulatory History of the Devices

    In the Federal Register of December 20, 1994 (59 FR 65475), FDA 
issued a final rule classifying the total TMJ prosthesis, the glenoid 
fossa prosthesis, the mandibular condyle prosthesis, and the 
interarticular disc prosthesis (interpositional implant) into class 
III. The preamble to the proposal (57 FR 43165, September 18, 1992) to 
classify these devices included the recommendation of the Dental 
Products Panel of the Medical Devices Advisory Committee (the Panel), 
an FDA advisory committee, which met on April 21, 1989, regarding the 
classification of the devices, in particular, the total TMJ prosthesis 
and the interarticular disc prosthesis (interpositional implant). The 
preamble to the reproposed rule (59 FR 6935, February 14, 1994) to 
classify the glenoid fossa prosthesis and the mandibular condyle 
prosthesis included the recommendation of the Panel that reconvened on 
February 11, 1993, regarding the classification of these two devices. 
The Panel recommended, at the April 1989 meeting, that the total TMJ 
prosthesis and the interarticular disc prosthesis (interpositional 
implant) be classified into class III, and at the February 1993 
meeting, the Panel recommended that the glenoid fossa prosthesis and 
the mandibular condyle prosthesis also be classified into class III, 
and identified certain risks to health presented by the devices. The 
Panel believed that the devices presented a potential unreasonable risk 
to health and that insufficient information existed to determine that 
general controls would provide reasonable assurance of the safety and 
effectiveness of the device or to establish performance standards which 
would provide reasonable assurance of the safety and effectiveness of 
the devices. FDA agreed with the Panel's recommendations and, in the 
September 18, 1992, proposal (57 FR 43165), and the February 14, 1994, 
reproposal (59 FR 6935), proposed that the total TMJ prosthesis, the 
glenoid fossa prosthesis, the mandibular condyle prosthesis and the 
interarticular disc prosthesis (interpositional implant) be classified 
into class III. The proposal and reproposal stated that FDA believed 
that general controls, either alone or in combination with the special 
controls applicable to class II devices are insufficient to provide 
reasonable assurance of the safety and effectiveness of the devices. 
The proposal and reproposal stated that premarket approval is necessary 
for the devices because the devices present potential unreasonable 
risks of illness or injury if there are not adequate data to ensure the 
safe and effective use of the devices. The preamble to the December 20, 
1994, final rule (59 FR 65475) classifying the total TMJ prosthesis, 
the glenoid fossa prosthesis, the mandibular condyle prosthesis and the 
interarticular disc prosthesis (interpositional implant) into class III 
advised that the earliest date by which PMA's or notices of completion 
of PDP's for the devices could be required was June 30, 1997, or 90 
days after issuance of a rule requiring premarket approval for the 
devices.
    In the Federal Register of January 6, 1989 (54 FR 550), FDA issued 
a notice of intent to initiate proceedings to require premarket 
approval for 31 class III preamendments devices. Among other items, the 
notice described the factors FDA takes into account in establishing 
priorities for proceedings under section 515(b) of the act (21 U.S.C. 
360e(b)) for issuing final rules requiring that preamendments class III 
devices have approved PMA's or declared completed PDP's. FDA updated 
its priorities in a preamendments class III strategy document made 
public through a Federal Register notice of availability published on 
May 6, 1994 (59 FR 23731). Though the above TMJ

[[Page 71744]]

prostheses were not included in the lists of devices identified in the 
notice and the strategy paper, using the factors set forth in these 
documents, FDA has determined that the total TMJ prosthesis identified 
in Sec. 872.3940 (21 CFR 872.3940), the glenoid fossa prosthesis 
identified in Sec. 872.3950 (21 CFR 872.3950), the mandibular condyle 
prosthesis identified in Sec. 872.3960 (21 CFR 872.3960), and the 
interarticular disc prosthesis identified in Sec. 872.3970 (21 CFR 
872.3970) have a high priority for initiating a proceeding to require 
premarket approval because the safety and effectiveness of these 
devices has not been established by valid scientific evidence as 
defined in 21 CFR 860.7. Moreover, FDA believes that insufficient 
information exists to identify the proper materials or design for the 
total TMJ, the glenoid fossa, and the mandibular condyle prostheses.
    In the Federal Register of July 17, 1997 (62 FR 38231), FDA issued 
a proposed rule to require the filing under section 515(b) of the act 
of a PMA or a notice of completion of a PDP for the total TMJ 
prosthesis, the glenoid fossa prosthesis, the mandibular condyle 
prosthesis, and the interarticular disc prosthesis (interpositional 
implant). FDA included in the preamble to the proposal the agency's 
proposed findings with respect to the degree of risk of illness or 
injury designed to be eliminated or reduced by requiring these devices 
to meet the premarket approval requirements of the act, and the 
benefits to the public from use of the devices (62 FR 38231 at 38233). 
The July 17, 1997, proposed rule also provided an opportunity for 
interested persons to submit comments on the proposed rule and the 
agency's findings. Under section 515(b)(2)(B) of the act, FDA also 
provided an opportunity for interested persons to request a change in 
the classification of the above devices based on new information 
relevant to its classification. Any petition requesting a change in the 
classification of the total TMJ prosthesis, the glenoid fossa 
prosthesis, the mandibular condyle prosthesis, and the interarticular 
disc prosthesis (interpositional implant) was required to be submitted 
by August 1, 1997. The comment period closed on October 15, 1997.

B. FDA's Intention to Reclassify the Temporary Mandibular Condyle 
Prosthesis

    FDA received a reclassification petition, dated April 30, 1996 
(Docket No. 96P-0253/CP-1), from Howmedica Leibinger, Inc., requesting 
the agency to reclassify from class III into class II the mandibular 
condyle prostheses (Sec. 872.3960) that are intended for temporary 
reconstruction of the mandibular condyle in tumor resection patients. 
Consistent with the act and the regulation, FDA referred the petition 
to the Panel for its recommendation on the requested change in 
classification. Based on its review of the new data and information 
contained in the reclassification petition, the Panel recommended, 
during its February 12, 1997, open meeting, that the temporary 
mandibular condyle prosthesis for temporary reconstruction of the 
mandibular condyle in patients who have undergone resective procedures 
to remove malignant or benign tumors, requiring the removal of the 
mandibular condyle, be reclassified from class III to class II. The 
Panel believed that class II with special controls, including a 
guidance document, patient registries, and labeling addressing certain 
identified issues, would provide a reasonable assurance of safety and 
effectiveness.
    On the basis of its review and the Panel's recommendation, FDA now 
believes that the use of the temporary mandibular condyle implant for 
temporary reconstruction of the mandibular condyle in tumor resection 
patients does not present a potential unreasonable risk of illness and 
injury, and that special controls would provide reasonable assurance of 
the safety and effectiveness of the device. The scope of Howmedica 
Leibinger's reclassification petition does not encompass all of the 
intended uses included in the current description of the mandibular 
condyle prosthesis in Sec. 872.3960. The reclassification requested is 
limited to the intended use of implantation into the human jaw for 
temporary reconstruction of the mandibular condyle in patients who have 
undergone resective procedures to remove malignant or benign tumors, 
requiring mandibular condyle removal. Therefore, FDA intends to grant 
this reclassification petition. The agency also intends to propose 
reclassifying from class III into class II the mandibular condyle 
prostheses implanted temporarily for such a limited purpose, 
identifying this subset of devices as the temporary mandibular condyle 
prosthesis. For the other uses of the mandibular condyle prosthesis for 
patients with temporomandibular joint dysfunction, or trauma patients, 
in which the device would be implanted for a much longer period of time 
for the purpose of permanent reconstruction, the device will remain in 
its current class (class III), as it is possible to place a device in a 
dual classification status. For clarity, FDA intends to identify the 
devices used for the latter purpose (permanent reconstruction) as the 
permanent mandibular condyle.

II. Summary and Analysis of Comments and FDA's Response

    The agency received four comments in response to the proposed rule. 
These comments were submitted by three manufacturers and distributors 
of TMJ implants, and a professional dental organization.
    1. One comment referenced the reclassification petition, as 
described in section I.B of this document, citing the February 12, 
1997, recommendation of the Dental Products Panel to reclassify from 
class III into class II the temporary mandibular condyle implant that 
is intended for temporary reconstruction of the mandibular condyle in 
tumor resection patients.
    As noted previously, FDA intends to propose reclassification of 
such devices into class II for certain temporary uses. Accordingly, the 
agency is excluding such temporary uses under Sec. 872.3960(c)(2) of 
this final rule. The agency is excluding any mandibular condyle 
prosthesis that is intended to be implanted in the human jaw for 
temporary reconstruction of the mandibular condyle in patients who have 
their mandibular condyle removed during resective procedures to remove 
malignant or benign tumors from the requirement of premarket approval 
set forth in Sec. 872.3960(c)(1).
    2. Two comments objected to the class III classification for 
metallic condylar prostheses, and other cobalt-chrome and cobalt-
chrome/polymethylmethacrylate TMJ implants, claiming that such TMJ 
devices do not present a potential unreasonable risk of injury and that 
sufficient information exists to address their safety and effectiveness 
through special controls.
    FDA has responded already to such materials-related issues in the 
December 20, 1994, final classification rule (59 FR 65475 at 65476).
    3. One of the previous comments also objected to the type of 
scientific evidence proposed by FDA for the PMA's to be submitted for 
TMJ prostheses, in terms of prospective randomized well-controlled 
clinical trials using adequate controls. The manufacturer/distributor 
advocated that valid scientific evidence can be obtained from any of 
the sources recognized in the Code of Federal Regulations, and that 
other sources of appropriate data are available than controlled 
clinical studies.
    FDA agrees that there is a variety of evidence that may be included 
as valid

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scientific evidence. In reviewing PMA's, FDA will consider a variety of 
evidence in determining safety and efficacy. FDA also agrees that the 
use of randomized concurrent controls in the clinical study of patients 
that require total joint replacement may not always be appropriate.
     4. One comment strongly supported the FDA proposal to require a 
PMA or a notice of completion of a PDP for these devices. The favorable 
comment emphasized that this action ``* * * would enhance the agency's 
ability to scrutinize and control these devices both before and after 
they enter the medical marketplace, and thereby better serve the needs 
of TMJ patients and the public.''

III. Final Rule

    Under section 515(b)(3) of the act, FDA is adopting the proposed 
findings as published in the preamble to the proposed rule and is 
issuing this final rule to require premarket approval of the TMJ 
prosthesis, the glenoid fossa prosthesis, the mandibular condyle 
prosthesis (intended for permanent reconstruction), and the 
interarticular disc prosthesis (interpositional implant).
    Under the final rule, a PMA or a notice of completion of a PDP is 
required to be filed with FDA within 90 days of the effective date of 
this regulation for any total TMJ prosthesis, glenoid fossa prosthesis, 
mandibular condyle prosthesis (intended for permanent reconstruction), 
or interarticular disc prosthesis (interpositional implant) that was in 
commercial distribution before May 28, 1976, or that have been found by 
FDA to be substantially equivalent to such devices on or before March 
30, 1999. An approved PMA is required to be in effect for any such 
devices on or before 180 days after FDA files the application or a 
declared completed PDP within 90 days after FDA files a notice of 
completion. Any total TMJ prosthesis, glenoid fossa prosthesis, 
mandibular condyle prosthesis (intended for permanent reconstruction) 
or interarticular disc prosthesis (interpositional implant) that was 
not in commercial distribution before May 28, 1976, or that FDA has not 
found, on or before March 30, 1999, to be substantially equivalent to 
such devices that were in commercial distribution before May 28, 1976, 
are required to have an approved PMA or a declared completed PDP in 
effect before it may be marketed.
    If a PMA or a notice of completion of a PDP for a total (TMJ) 
prosthesis, glenoid fossa prosthesis, mandibular condyle prosthesis 
(intended for permanent reconstruction), or interarticular disc 
prosthesis (interpositional implant) is not filed on or before March 
30, 1999, that device will be deemed adulterated under section 
501(f)(1)(A) of the act (21 U.S.C. 351(f)(1)(A)), and commercial 
distribution of the device will be required to cease immediately. The 
device may, however, be distributed for investigational use, if the 
requirements of the investigational device exemption (IDE) regulations 
under part 812 (21 CFR part 812) are met.
    Under Sec. 812.2(d) of the IDE regulations, FDA hereby stipulates 
that the exemptions from the IDE requirements in Sec. 812.2(c)(1) and 
(c)(2) will no longer apply to clinical investigations of the total TMJ 
prosthesis, the glenoid fossa prosthesis, the mandibular condyle 
prosthesis (intended for permanent reconstruction), and the 
interarticular disc prosthesis (interpositional implant). Further, FDA 
concludes that investigational total TMJ prosthetic devices, glenoid 
fossa prosthetic devices, mandibular condyle prosthetic devices 
(intended for permanent reconstruction), and interarticular disc 
prosthetic (interpositional implant) devices are significant risk 
devices as defined in Sec. 812.3(m) and advises that as of the 
effective date of the regulations in Secs. 872.3940(c), 872.3950(c), 
872.3960(c)(1), and 872.3970(c), respectively, requirements of the IDE 
regulations regarding significant devices will apply to any clinical 
investigations of any of these devices. For any total TMJ prosthesis, 
glenoid fossa prosthesis, mandibular condyle prosthesis (intended for 
permanent reconstruction), or interarticular disc prosthesis 
(interpositional implant) that is not subject to a timely filed PMA or 
notice of completion of a PDP, an IDE must be in effect under 
Sec. 812.20 on or before March 30, 1999, or distribution of the device 
for investigational purposes must cease. FDA advises all persons 
currently sponsoring a clinical investigation involving the total TMJ 
prosthesis, the glenoid fossa prosthesis, the mandibular condyle 
prosthesis (intended for permanent reconstruction), or the 
interarticular disc prosthesis (interpositional implant) to submit an 
IDE application to FDA no later than March 1, 1999, to avoid the 
interruption of ongoing investigations.

IV. 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 significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

V. Analysis of Impacts

    The agency has examined the impacts of the final rule under 
Executive Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-
354) (as amended by subtitle D of the Small Business Regulatory 
Fairness Act (Pub. L. 104-121), and the Unfunded Mandates Reform Act of 
1995 (Pub. L. 104-4)). 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 PMA's for these devices could have been 
required by FDA as early as June 30, 1997, and manufacturers have been 
aware since December 20, 1994, that these devices are class III devices 
that would be subject to premarket approval, and because firms that 
distributed these devices prior to May 28, 1976, or whose devices have 
been found to be substantially equivalent to the total TMJ prosthesis, 
the glenoid fossa prosthesis, the mandibular condyle prosthesis 
(intended for permanent reconstruction), and the interarticular disc 
prosthesis (interpositional implant), will be permitted to continue 
marketing these TMJ devices during FDA's review of the PMA or the 
notice of completion of the PDP, 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:

[[Page 71746]]

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 872.3940 is amended by revising paragraph (c) to read as 
follows:


Sec. 872.3940   Total temporomandibular joint prosthesis.

* * * * *
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before March 30, 1999, for any total 
temporomandibular joint prosthesis that was in commercial distribution 
before May 28, 1976, or that has, on or before March 30, 1999, been 
found to be substantially equivalent to a total temporomandibular joint 
prosthesis that was in commercial distribution before May 28, 1976. Any 
other total temporomandibular joint prosthesis shall have an approved 
PMA or a declared completed PDP in effect before being placed in 
commercial distribution.
    3. Section 872.3950 is amended by revising paragraph (c) to read as 
follows:


Sec. 872.3950   Glenoid fossa prosthesis.

* * * * *
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before March 30, 1999, for any glenoid 
fossa prosthesis that was in commercial distribution before May 28, 
1976, or that has on or before March 30, 1999, been found to be 
substantially equivalent to a glenoid fossa prosthesis that was in 
commercial distribution before May 28, 1976. Any other glenoid fossa 
prosthesis shall have an approved PMA or a declared completed PDP in 
effect before being placed in commercial distribution.
    4. Section 872.3960 is amended by revising paragraph (c) to read as 
follows:


Sec. 872.3960   Mandibular condyle prosthesis.

* * * * *
    (c) Date PMA or notice of completion of a PDP is required. (1) 
Except as described in paragraph (c)(2) of this section, a PMA or a 
notice of completion of a PDP is required to be filed with the Food and 
Drug Administration on or before March 30, 1999, for any mandibular 
condyle prosthesis that was in commercial distribution before May 28, 
1976, or that has, on or before March 30, 1999, been found to be 
substantially equivalent to a mandibular condyle prosthesis that was in 
commercial distribution before May 28, 1976. Any other mandibular 
condyle prosthesis shall have an approved PMA or a declared completed 
PDP in effect before being placed in commercial distribution.
    (2) No effective date has been established of the requirement for 
premarket approval for any mandibular condyle prosthesis intended to be 
implanted in the human jaw for temporary reconstruction of the 
mandibular condyle in patients who have undergone resective procedures 
to remove malignant or benign tumors, requiring the removal of the 
mandibular condyle. See Sec. 870.3 of this chapter.
    5. Section 872.3970 is amended by revising paragraph (c) to read as 
follows:


Sec. 872.3970   Interarticular disc prosthesis (interpositional 
implant).

* * * * *
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before March 30, 1999, for any 
interarticular disc prosthesis (interpositional implant) that was in 
commercial distribution before May 28, 1976, or that has on or before 
March 30, 1999, been found to be substantially equivalent to an 
interarticular disc prosthesis (interpositional implant) that was in 
commercial distribution before May 28, 1976. Any other interarticular 
disc prosthesis (interpositional implant) shall have an approved PMA or 
a declared completed PDP in effect before being placed in commercial 
distribution.

    Dated: November 23, 1998.
D.B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 98-34483 Filed 12-29-98; 8:45 am]
BILLING CODE 4160-01-F