[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