Document ID: FDA-2012-N-1239-0001
Agency: fda
Document Type: Proposed Rule
Title: Dental Devices: Reclassification of Temporary Mandibular Condyle Prosthesis
Posted Date: 2013-02-07T05:00Z

[Federal Register Volume 78, Number 26 (Thursday, February 7, 2013)]
[Proposed Rules]
[Pages 9010-9015]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-02688]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 872

[Docket No. FDA-2012-N-1239]

Dental Devices; Reclassification of Temporary Mandibular Condyle 
Prosthesis

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed order.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a proposed 
order to reclassify temporary mandibular condyle prosthesis, a 
preamendments class III device, into class II (special controls), and 
rename the device ``temporary mandibular condyle reconstruction 
plate.'' FDA is also issuing the draft special controls guideline, 
``Class II Special Controls Guideline: Temporary Mandibular Condyle 
Reconstruction Plate,'' which sets forth the special controls that the 
Agency believes are necessary to provide a reasonable assurance of the 
safety and effectiveness of the device.

DATES: Submit either electronic or written comments on this proposed 
order or on the draft guideline by May 8, 2013. See section XIII of 
this document for the proposed effective date of any final order that 
may publish based on this proposed order.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2012-
N-1239, by any of the following methods:

[[Page 9011]]

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper or CD-ROM 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name 
and Docket No. FDA-2012-N-1239. All comments received may be posted 
without change to http://www.regulations.gov, including any personal 
information provided. For additional information on submitting 
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION 
section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number(s), found in brackets in the heading of this document, 
into the ``Search'' box and follow the prompts and/or go to the 
Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852.

FOR FURTHER INFORMATION CONTACT: Michael Ryan, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, rm. 1615, Silver Spring, MD 20993, 301-796-6283.

SUPPLEMENTARY INFORMATION: 

I. Background--Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended 
by the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L. 
94-295), the Safe Medical Devices Act of 1990 (Pub. L. 101-629), the 
Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L. 
105-115), the Medical Device User Fee and Modernization Act of 2002 
(Pub. L. 107-250), the Medical Devices Technical Corrections Act (Pub. 
L. 108-214), the Food and Drug Administration Amendments Act of 2007 
(Pub. L. 110-85), and the Food and Drug Administration Safety and 
Innovation Act (FDASIA) (Pub. L. 112-144), among other amendments, 
established a comprehensive system for the regulation of medical 
devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 
360c) established three categories (classes) of devices, reflecting 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).
    Under section 513(d) of the FD&C Act, devices that were in 
commercial distribution before the enactment of the 1976 amendments, 
May 28, 1976 (generally referred to as preamendments devices), are 
classified after FDA has: (1) Received a recommendation from a device 
classification 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. FDA has classified most preamendments devices 
under these procedures.
    Devices that were not in commercial distribution prior to May 28, 
1976 (generally referred to as postamendments devices) are 
automatically classified by section 513(f) of the FD&C Act into class 
III without any FDA rulemaking process. Those devices remain in class 
III and require premarket approval unless, and until, the device is 
reclassified into class I or II or FDA issues an order finding the 
device to be substantially equivalent, in accordance with section 
513(i) of the FD&C Act, to a predicate device that does not require 
premarket approval. The Agency determines whether new devices are 
substantially equivalent to predicate devices by means of premarket 
notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 
360(k)) and part 807 (21 CFR part 807).
    On July 9, 2012, FDASIA was enacted. Section 608(a) of FDASIA (126 
Stat. 1056) amended section 513(e) of the FD&C Act, changing the 
process for reclassifying a device from rulemaking to an administrative 
order.
    Section 513(e) of the FD&C Act governs reclassification of 
classified preamendments devices. This section provides that FDA may, 
by administrative order, reclassify a device based upon ``new 
information.'' FDA can initiate a reclassification under section 513(e) 
or an interested person may petition FDA to reclassify a preamendments 
device. The term ``new information,'' as used in section 513(e) of the 
FD&C Act, includes information developed as a result of a reevaluation 
of the data before the Agency when the device was originally 
classified, as well as information not presented, not available, or not 
developed at that time. (See, e.g., Holland-Rantos Co. v. United States 
Department of Health, Education, and Welfare, 587 F.2d 1173, 1174 n.1 
(DC Cir. 1978); Upjohn v. Finch, 422 F.2d 944 (6th Cir. 1970); Bell v. 
Goddard, 366 F.2d 177 (7th Cir. 1966).)
    Reevaluation of the data previously before the Agency is an 
appropriate basis for subsequent action where the reevaluation is made 
in light of newly available authority (see Bell, 366 F.2d at 181; 
Ethicon, Inc. v. FDA, 762 F.Supp. 382, 388-391 (D.D.C. 1991)), or in 
light of changes in ``medical science'' (Upjohn, 422 F.2d at 951). 
Whether data before the Agency are old or new data, the ``new 
information'' to support reclassification under section 513(e) must be 
``valid scientific evidence,'' as defined in section 513(a)(3) of the 
FD&C Act and 21 CFR 860.7(c)(2). (See, e.g., General Medical Co. v. 
FDA, 770 F.2d 214 (DC Cir. 1985); Contact Lens Association v. FDA, 766 
F.2d 592 (DC Cir. 1985), cert. denied, 474 U.S. 1062 (1986).)
    FDA relies upon ``valid scientific evidence'' in the classification 
process to determine the level of regulation for devices. To be 
considered in the reclassification process, the ``valid scientific 
evidence'' upon which the Agency relies must be publicly available. 
Publicly available information excludes trade secret and/or 
confidential commercial information, e.g., the contents of a pending 
premarket approval application (PMA). (See section 520(c) of the FD&C 
Act (21 U.S.C. 360j(c)).) Section 520(h)(4) of the FD&C Act, added by 
FDAMA, provides that FDA may use, for reclassification of a device, 
certain information in a PMA 6 years after the application has been 
approved. This includes information from clinical and preclinical tests 
or studies that demonstrate the safety or effectiveness of the device 
but does not include descriptions of methods of manufacture or product 
composition and other trade secrets.
    Section 513(e)(1) of the FD&C Act sets forth the process for 
issuing a final order. Specifically, prior to the issuance of a final 
order reclassifying a device, the following must occur: (1) Publication 
of a proposed order in the Federal Register; (2) a meeting of a device 
classification panel described in section 513(b) of the FD&C Act; and 
(3) consideration of comments to a public docket. FDA has held a 
meeting of a device classification panel described in section 513(b) of 
the FD&C Act with respect to temporary mandibular condyle prosthesis, 
and therefore, has met this requirement under section 513(e)(1) of the 
FD&C Act. As explained further in section II of this document, a 
meeting of a device classification panel

[[Page 9012]]

described in section 513(b) of the FD&C Act took place in 1997 to 
discuss whether temporary mandibular condyle prosthesis should be 
reclassified or remain in class III, and the panel recommended that the 
device be reclassified into class II because there was sufficient 
information to establish special controls. FDA is not aware of new 
information since the 1997 panel that would provide a basis for a 
different recommendation or findings.
    FDAMA added section 510(m) to the FD&C Act. Section 510(m) of the 
FD&C Act provides that a class II device may be exempted from the 
premarket notification requirements under section 510(k) of the FD&C 
Act, if the Agency determines that premarket notification is not 
necessary to assure the safety and effectiveness of the device.

II. Regulatory History of the Device

    In 1994, FDA issued a final rule that classified all mandibular 
condyle prostheses into class III, based on the recommendation of a 
Dental Products Panel (the Panel) meeting on February 11, 1993 (59 FR 
65475; December 20, 1994). In response to a petition dated April 30, 
1996 (FDA-1996-P-0253), FDA considered a distinction between temporary 
and permanent mandibular condyle prostheses and held a February 12, 
1997 meeting of the Panel. The Panel recommended that mandibular 
condyle prostheses indicated for temporary reconstruction of the 
mandibular condyle in tumor resection patients be reclassified from 
class III to class II with special controls, include labeling for 
temporary use not to exceed 2 years, and have patient registries. Based 
on its review of the data and information contained in the April 30, 
1996, petition, the Panel believed that special controls, in addition 
to general controls, were necessary to provide a reasonable assurance 
of safety and effectiveness of these devices in patients who have 
undergone resective procedures to remove malignant or benign tumors, 
requiring the removal of the mandibular condyle and mandibular bone. On 
December 30, 1998, FDA issued a final rule calling for PMAs under 
section 515(b) of the FD&C Act (21 U.S.C. 360e(b)) for permanent 
mandibular condyle prostheses, and simultaneously announced its 
intention to reclassify, in accordance with the Panel's 
recommendations, mandibular condyle prosthesis for temporary 
reconstruction following surgical ablation of malignant and benign 
tumors (63 FR 71743).
    In 2009, FDA published an order for the submission of information 
on mandibular condyle prostheses indicated for temporary reconstruction 
(74 FR 16214; April 9, 2009). In response to that order, FDA received 
information from several device manufacturers who recommended that 
these devices be reclassified to class II. The manufacturers stated 
that the safety and effectiveness of these devices may be reasonably 
assured by bench testing, biocompatibility testing, sterility testing, 
expiration date testing, labeling, and performance standards.
    On the basis of its review and the recommendations from the Panel 
and industry, FDA now believes that the use of temporary mandibular 
condyle prostheses for patients who have undergone any resective 
surgical procedure requiring removal of the mandibular condyle and 
mandibular bone does not present a potential unreasonable risk of 
illness and injury, and that special controls, in addition to general 
controls, are necessary to provide reasonable assurance of the safety 
and effectiveness of the device. Although the Panel recommended that 
class II was appropriate for plates indicated in tumor resection cases 
only, FDA believes that the special controls proposed in this document 
are appropriate to provide reasonable assurance of safety and 
effectiveness for temporary reconstruction of the mandibular condyle in 
patients who have undergone any resective surgical procedures requiring 
removal of the mandibular condyle and mandibular bone.

III. Device Description

    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.
    FDA is proposing this order to create a new classification for the 
temporary mandibular condyle prosthesis and rename it the temporary 
mandibular condyle reconstruction plate (TMCRP) to distinguish it from 
permanent mandibular condyle prosthesis. TMCRP devices will be 
identified as:
    A TMCRP is a device that is intended to stabilize mandibular bone 
and provide for temporary reconstruction of the mandibular condyle 
until permanent reconstruction is completed in patients who have 
undergone resective surgical procedures requiring removal of the 
mandibular condyle and mandibular bone. This device is not intended for 
treatment of temporomandibular joint disorders.
    The new classification will be placed under 21 CFR part 872, 
subpart E--Surgical Devices, as a TMCRP is not intended to permanently 
replace the function of the mandibular condyle.

IV. Proposed Reclassification

    FDA is proposing that temporary mandibular condyle prosthesis be 
reclassified from class III to class II with a special controls 
guideline. FDA is also proposing to create a separate classification 
for these devices, to rename them temporary mandibular condyle 
reconstruction plate, and place them under 21 CFR part 872, subpart E--
Surgical Devices, to differentiate them from permanent mandibular 
condyle prostheses and clarify that these devices are intended as 
temporary devices and not permanent replacements of the mandibular 
condyle. FDA believes that these devices can be utilized to stabilize 
mandibular bone and provide for temporary reconstruction of the 
mandibular condyle until permanent reconstruction is completed in 
patients who have undergone resective surgical procedures requiring 
removal of the mandibular condyle and mandibular bone.
    FDA has considered TMCRPs in accordance with the reserved criteria 
and determined that these devices require premarket notification. The 
Agency does not intend to exempt this proposed class II device from 
premarket notification (section 510(k) of the FD&C Act) submission as 
provided for under section 510(m) of the FD&C Act.

V. Risks to Health

    After considering the information from the reports and 
recommendations of the Panel for the classification of these devices 
along with information submitted in response to the section 515(i) 
order and any additional information that FDA has at its disposal, FDA 
has identified and evaluated the risks to health associated with the 
use of TMCRPs. The Panel had identified these risks to health for all 
mandibular condyle prostheses in a February 11, 1993, meeting; FDA 
believes that the risks listed in this document are applicable to 
TMCRPs, a subset of mandibular condyle prostheses, and that these 
concerns are still relevant today.
     Loosening, migration, or exposure. TMCRP screws or plates 
may loosen if not placed properly. A loose plate can also lead to 
migration or exposure of the plate or screws through the skin.
     Mechanical wear of the plate or screws and foreign body 
reaction. Some materials used in the construction of a TMCRP may wear 
and release particles that may result in a foreign body reaction.

[[Page 9013]]

     Structural/mechanical failure. A TMCRP may loosen, bend, 
or fracture and result in a structural or mechanical failure of the 
plate if not placed properly or used longer than intended.
     Migration or thermal injury from magnetic resonance scans. 
A TMCRP is composed of metals. Certain metallic materials that may be 
used for a TMCRP can be induced to displace or heat up in the presence 
of a magnetic field, such as is found in magnetic resonance scans.
     Corrosion. A TMCRP is composed of metals. Some materials 
to be used for a TMCRP may corrode, which can lead to failure and 
adverse tissue reaction.
     Adverse reaction to a TMCRP. Placement of a TMCRP may 
result in an adverse reaction in certain individuals who may be 
hypersensitive or allergic to the materials of composition of the 
TMCRP.
     Infection. Placement of a TMCRP may result in a 
postoperative infection due to the surgical procedure or if the plate 
or screws have not been sterilized appropriately.
     Degenerative changes to the glenoid fossa surfaces. A 
TMCRP may cause degeneration of the opposing bone, which is an inherent 
risk of a metal-on-bone joint.
     Malocclusion, changes in mastication and contralateral 
joint. A TMCRP may cause an uneven bite, resulting in malocclusion and 
potential changes in the contralateral joint, which is a unique risk of 
a bilateral joint.
     User error. A TMCRP may be misused if placed incorrectly 
or if inappropriately used as a permanent prosthesis rather than a 
temporary reconstruction plate.
     Transient or chronic pain and facial nerve paresis. 
Placement of a TMCRP may cause transient or chronic pain or nerve 
paresis associated with changes in jaw structure and function as a 
result of the surgical procedure.

VI. Summary of Reasons for Reclassification

    FDA believes that TMCRPs should be reclassified into class II 
because special controls, in addition to general controls, are 
necessary to provide reasonable assurance of the safety and 
effectiveness of the devices. In addition, there is now sufficient 
information sufficient to establish special controls to provide such 
assurance.

VII. Summary of Data Upon Which the Reclassification Is Based

    FDA believes that the identified special controls, in addition to 
general controls, are necessary to provide reasonable assurance of 
safety and effectiveness of these devices. Therefore, in accordance 
with sections 513(e) and 515(i) of the FD&C Act and 21 CFR 860.130, 
based on new information with respect to the device, FDA, on its own 
initiative, is proposing to reclassify this preamendments class III 
device into class II. The new information includes the history of use 
of the device and the relative absence of adverse events reports 
despite the longstanding use of these devices, as discussed in the 
recommendations for reclassification from the device industry 
(available in docket FDA-2009-M-0101 at http://www.regulations.gov) and 
the February 12, 1997, Panel. The classification recommendations from 
the device industry recommend that FDA reclassify these devices to 
class II based on their history of use without evidence of serious 
adverse events and the ability of preclinical data to provide 
predictive performance information. These companies cite their own 
history of use, their own preclinical testing, and relevant peer-
reviewed literature that provide evidence that TMCRPs are effective for 
temporary reconstruction of the mandible and not associated with 
complications. (Ref. 1) The Panel also recommended reclassification to 
class II for these devices and believed that special controls, in 
addition to general controls, would provide a reasonable assurance of 
safety and effectiveness for these devices. (Ref. 2) FDA believes that 
this information constitutes sufficient evidence to demonstrate that 
the proposed special controls can effectively mitigate the risks to 
health identified in section V of this document, which are known 
surgical risks, and that these special controls in addition to the 
general controls will provide a reasonable assurance of safety and 
effectiveness for TMCRPs. Although the Panel only recommended that 
class II was appropriate for plates indicated in tumor resection cases 
only, FDA believes that the proposed special controls are appropriate 
to provide reasonable assurance of safety and effectiveness for 
temporary reconstruction of the mandibular condyle in patients who have 
undergone any resective surgical procedures requiring removal of the 
mandibular condyle and mandibular bone. Other clinical instances that 
may result in mandibular resection include certain traumas, 
osteoradionecrosis, bisphosphonate-induced osteonecrosis, and 
osteomyelitis. FDA believes that the risks of using TMCRPs in these 
instances are the same as the risks in tumor resection cases, and 
therefore the identified special controls can provide a reasonable 
assurance of safety and effectiveness for TMCRPs in the following 
indications: when used to stabilize mandibular bone and provide for 
temporary reconstruction of the mandibular condyle until permanent 
reconstruction is completed in patients who have undergone resective 
surgical procedures requiring removal of the mandibular condyle and 
mandibular bone.

VIII. Proposed Special Controls--Related Document

    FDA believes that the measures set forth in the special controls 
guideline ``Class II Special Controls Guideline: Temporary Mandibular 
Condyle Reconstruction Plate'' are necessary, in addition to general 
controls, to mitigate the risks to health described in section V in 
this document. As seen in the following table, the special controls set 
forth in the guideline for this device address each of the identified 
risks.

                                  Table 1--TMCRP Risks and Mitigation Measures
----------------------------------------------------------------------------------------------------------------
             Identified risk                                         Mitigation measure
----------------------------------------------------------------------------------------------------------------
Loosening, migration or exposure.........  Section 5--Materials and Performance Data.
                                           Section 8--Labeling.
Mechanical wear of the plate or screws     Section 5--Materials and Performance Data.
 and foreign body reaction.
Structural/mechanical failure............  Section 5--Materials and Performance Data.
Migration or thermal injury from magnetic  Section 5--Materials and Performance Data
 resonance scans.
Corrosion................................  Section 5--Materials and Performance Data
Adverse reaction to TMCRP................  Section 6--Biocompatibility.
Infection................................  Section 7--Sterilization.
Degenerative changes to glenoid fossa      Section 8--Labeling.
 surfaces.
Malocclusion, changes in mastication, and  Section 8--Labeling.
 contralateral joint.
User error...............................  Section 8--Labeling.

[[Page 9014]]

 
Transient or chronic pain and facial       Section 8--Labeling.
 nerve paresis.
----------------------------------------------------------------------------------------------------------------

    If this proposed order is finalized, TMCRPs will be reclassified 
into Class II. As discussed below, the reclassification will be 
codified in 21 CFR 872.4770. Firms submitting a 510(k) for a TMCRP will 
need either to (1) comply with the particular mitigation measures set 
forth in the special controls guideline or (2) use alternative 
mitigation measures, but demonstrate to the Agency's satisfaction that 
alternative measures identified by the firm will provide at least an 
equivalent assurance of safety and effectiveness. Adherence to the 
criteria in the guideline, when finalized, in addition to the general 
controls, is necessary to provide a reasonable assurance of the safety 
and effectiveness of the devices.

IX. Electronic Access to the Special Controls Guideline

    Persons interested in obtaining a copy of the draft guideline may 
do so by using the Internet. A search capability for all Center for 
Devices and Radiological Health guidelines and guidance documents is 
available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. The 
guideline is also available at http://www.regulations.gov.
    To receive ``Class II Special Controls Guideline: Temporary 
Mandibular Condyle Reconstruction Plate,'' you may either send an email 
request to dsmica@fda.hhs.gov to receive an electronic copy of the 
document or send a fax request to 301-847-8149 to receive a hard copy. 
Please use the document number 1799 to identify the guidance you are 
requesting.

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

XI. Paperwork Reduction Act of 1995

    This proposed order refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 812 have been approved under 
OMB control number 0910-0078; the collections of information in part 
807, subpart E, have been approved under OMB control number 0910-0120; 
the collections of information in part 814, subpart B, have been 
approved under OMB control number 0910-0231; and the collections of 
information under 21 CFR part 801 have been approved under OMB control 
number 0910-0485.

XII. Clarifications to Special Controls Guidelines

    This special controls guideline reflects changes the Agency is 
making to clarify its position on the binding nature of special 
controls. The changes include referring to the document as a 
``guideline,'' as that term is used in section 513(a) of the FD&C Act, 
which the Secretary has developed and disseminated to provide a 
reasonable assurance of safety and effectiveness for class II devices, 
and not a ``guidance,'' as that term is used in 21 CFR 10.115. The 
guideline also clarifies that firms will need either to (1) comply with 
the particular mitigation measures set forth in the special controls 
guideline or (2) use alternative mitigation measures, but demonstrate 
to the Agency's satisfaction that those alternative measures identified 
by the firm will provide at least an equivalent assurance of safety and 
effectiveness. Finally, the guideline uses mandatory language to 
emphasize that firms must comply with special controls to legally 
market their class II devices. These revisions do not represent a 
change in FDA's position about the binding effect of special controls, 
but rather are intended to address any possible confusion or 
misunderstanding.

XIII. Proposed Effective Date

    FDA is proposing that any final order based on this proposed order 
become effective on the date of its publication in the Federal Register 
or at a later date if stated in the final order.

XIV. Comments

    Interested persons may submit either electronic comments regarding 
this document or the associated Special Controls guideline to http://www.regulations.gov or written comments to the Division of Dockets 
Management (see ADDRESSES). It is only necessary to send one set of 
comments. Identify comments with the docket number found in brackets in 
the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday, and will be posted to the docket at http://www.regulations.gov.

XV. Codification of Orders

    Prior to the amendments by FDASIA, section 513(e) provided for FDA 
to issue regulations to reclassify devices. Although section 513(e) as 
amended requires FDA to issue final orders rather than regulations, 
FDASIA also provides for FDA to revoke previously promulgated 
regulations by order. FDA will continue to codify classifications and 
reclassifications in the Code of Federal Regulations (CFR). Changes 
resulting from final orders will appear in the CFR as changes to 
codified classification determinations or as newly codified orders. 
Therefore, pursuant to section 513(e)(1)(A)(i), as amended by FDASIA, 
in this proposed order, we are proposing to revoke the requirements in 
21 CFR 872.3960 related to the classification of TMCRPs as Class III 
devices and to codify the reclassification of TMCRPs into Class II.

XVI. References

    The following references have been placed on display in the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
    1. Carlson, E.R., Disarticulation Resections of the Mandible: A 
Prospective Review of 16 Cases. Journal of Oral and Maxillofacial 
Surgery, vol. 60, pp. 176-181, 2002.
    2. Food and Drug Administration, Dental Products Advisory Panel 
Meeting Transcript, February 12, 1997; http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/details.cfm?mtg=168.

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

[[Page 9015]]

of Food and Drugs, it is proposed that 21 CFR part 872 be amended as 
follows:

 PART 872--DENTAL DEVICES

0
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.

0
2. 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 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 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.
0
3. Section 872.4770 is added to subpart E to read as follows:

Sec.  872.4770  Temporary mandibular condyle reconstruction plate.

    (a) Identification. A temporary mandibular condyle reconstruction 
plate is a device that is intended to stabilize mandibular bone and 
provide for temporary reconstruction of the mandibular condyle until 
permanent reconstruction is completed in patients who have undergone 
resective surgical procedures requiring removal of the mandibular 
condyle and mandibular bone. This device is not intended for treatment 
of temporomandibular joint disorders.
    (b) Classification. Class II (special controls). The special 
controls is FDA's guideline, ``Class II Special Controls Guideline: 
Temporary Mandibular Condyle Reconstruction Plate.'' See Sec.  872.1(e) 
for the availability of this guidance document.

    Dated: February 1, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-02688 Filed 2-6-13; 8:45 am]
BILLING CODE 4160-01-P