[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