[Federal Register Volume 78, Number 250 (Monday, December 30, 2013)]
[Rules and Regulations]
[Pages 79308-79310]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-31217]


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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: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a final 
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 special controls guideline entitled 
``Temporary Mandibular Condyle Reconstruction Plate Class II Special 
Controls Guideline'' that sets forth the special controls that are 
necessary to provide a reasonable assurance of the safety and 
effectiveness of the device.

DATES: This order is effective December 30, 2013.

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 
mechanism 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) 
of the FD&C Act 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 (D.C. 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 (D.C. Cir. 1985); Contact Lens Association v. FDA, 
766 F.2d 592 (D.C.

[[Page 79309]]

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 published a 
proposed order to reclassify this device in the Federal Register of 
February 7, 2013 (78 FR 9010) (the 2013 proposed order). FDA received 
and has considered one comment on the 2013 proposed order, as discussed 
in section II of this document. On February 12, 1997, FDA 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 
(the 1997 Panel), and therefore, has met this requirement under section 
513(e)(1) of the FD&C Act. As explained further in section II of the 
2013 proposed order, a meeting of a device classification panel 
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 1997 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.

II. Public Comments in Response to the Proposed Order

    In response to the 2013 proposed order to reclassify temporary 
mandibular condyle prostheses and rename the device temporary 
mandibular condyle reconstruction plates (TMCRPs), FDA received one 
comment. This comment disagreed with FDA's intent to reclassify these 
devices from class III to class II. The commenter believes that TMCRPs 
should be classified as class III (PMA) devices, similar to permanent 
mandibular condyle prostheses, because reclassification to class II 
(special controls) would allow TMCRPs to enter the market and be used 
off-label for permanent use. FDA disagrees with this comment. FDA 
generally does not regulate the practice of medicine but rather 
regulates the use of a device as indicated by the party offering the 
device for interstate commerce. The indications for TMCRP are limited 
to temporary use by the codified identification. FDA is requiring in 
the special control guideline for this device (see section IV of this 
final order) patient labeling for TMCRP devices that clearly indicate 
that the device ``is intended for temporary use (defined as less than 
24 months) only. It is not intended to permanently reconstruct the TMJ. 
It is not intended for permanent treatment of TMJ disorders.'' FDA 
recommends that patients discuss the risks and benefits of any 
treatment with their surgeon, especially if off-label use is involved.
    The commenter also states that the special controls are not 
rigorous enough and that clinical trials are necessary to provide a 
reasonable assurance of the device's safety and effectiveness. The 
commenter suggests that classification to class II (special controls) 
precludes FDA from requesting clinical data for these devices. FDA 
disagrees with this comment. FDA believes that the special controls 
provide a reasonable assurance of safety and effectiveness for TMCRP 
devices that feature similar technology and indications. The Agency 
believes it has identified all relevant risks to health (see section V 
of the 2013 proposed order) and that the mitigation methods described 
in the associated special controls guideline will be effective in 
mitigating these risks. These risks and mitigations were based on 
recommendations from the 1997 Panel and information provided by 
manufacturers in response to the section 515(i) of the FD&C Act call 
for information, which included information on preclinical testing and 
literature reports demonstrating that TMCRPs are effective for 
temporary reconstruction of the mandible and not associated with 
complications. FDA is also not precluded from requesting clinical data 
for TMCRP devices where it is necessary to demonstrate substantial 
equivalence. See section 513(a)(1)(B) of the FD&C Act.
    The commenter also states that the new identification for this 
device is misleading and that the device should be limited to 
terminally ill patients who have had a tumor resection procedure. FDA 
disagrees with these comments. FDA believes the 1997 Panel did not 
intend to limit the use of TMCRP to terminally ill patients. FDA 
believes that the identified risks to health associated with TMCRP 
devices are inclusive for a patient population that has undergone 
resective surgical procedures, whether the result of a tumor or not, 
that requires the removal of the mandibular condyle and mandibular 
bone. Further, FDA believes that the identified special controls 
mitigate these risks and provide a reasonable assurance of safety and 
effectiveness in this patient population.

III. The Final Order

    Under section 513(e) of the FD&C Act, FDA is adopting its findings 
as published in the preamble to the 2013 proposed order. FDA is issuing 
this final order to reclassify temporary mandibular condyle prostheses 
from class III to class II, rename them temporary mandibular condyle 
reconstruction plates, and establish special controls by revising part 
872 (21 CFR part 872).
    Section 510(m) of the FD&C Act provides that FDA may exempt a class 
II device from the premarket notification requirements under section 
510(k) of the FD&C Act if FDA determines that premarket notification is 
not necessary to provide reasonable assurance of the safety and 
effectiveness of the devices. FDA has determined that premarket 
notification is necessary to provide reasonable assurance of safety and 
effectiveness of TMCRPs, and therefore, this device type is not exempt 
from premarket notification requirements.

IV. Electronic Access to the Special Controls Guideline

    Persons interested in obtaining a copy of the 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

[[Page 79310]]

guideline is also available at http://www.regulations.gov.
    To receive ``Temporary Mandibular Condyle Reconstruction Plate 
Class II Special Controls Guideline,'' you may either send an email 
request to [email protected] 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.

V. 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.

VI. Paperwork Reduction Act of 1995

    This final order refers to currently 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 21 CFR 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.

VII. Clarifications to Special Controls Guidelines

    The 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.

VIII. Codification of Orders

    Prior to the amendments by FDASIA, section 513(e) of the FD&C Act 
provided for FDA to issue regulations to reclassify devices. Although 
section 513(e) of the FD&C Act as amended requires FDA to issue final 
orders rather than regulations, FDASIA also provides for FDA to revoke 
previously issued 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, under section 513(e)(1)(A)(i) of the 
FD&C Act, as amended by FDASIA, in this final order, we are revoking 
the requirements in Sec.  872.3960 related to the classification of 
TMCRPs as Class III devices and codifying the reclassification of 
TMCRPs into Class II.

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

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 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 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 for this device is FDA's guideline entitled ``Temporary 
Mandibular Condyle Reconstruction Plate Class II Special Controls 
Guideline.'' See Sec.  872.1(e) for the availability of this guidance 
document.

    Dated: December 23, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-31217 Filed 12-27-13; 8:45 am]
BILLING CODE 4160-01-P