[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
[[Page 71745]]
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