[Federal Register Volume 79, Number 117 (Wednesday, June 18, 2014)]
[Rules and Regulations]
[Pages 34623-34625]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-14216]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 872
[Docket No. FDA-2012-N-0677]
Dental Devices; Reclassification of Blade-Form Endosseous Dental
Implant
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 the blade-form endosseous dental implant, a
preamendments class III device, into class II (special controls). On
its own initiative, based on new information, FDA is revising the
classification of blade-form endosseous dental implants.
DATES: This order is effective July 18, 2014.
FOR FURTHER INFORMATION CONTACT: Michael J. Ryan, Center for Devices
and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 1615,
Silver Spring, MD 20993, 301-796-6283, [email protected].
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 21 CFR part 807.
A preamendments device that has been classified into class III may
be marketed by means of premarket notification procedures (510(k)
process) without submission of a premarket approval application (PMA)
until FDA issues a final order under section 515(b) of the FD&C Act (21
U.S.C. 360e(b)) requiring premarket approval or until the device is
subsequently reclassified into class I or class II.
On July 9, 2012, FDASIA was enacted. Section 608(a) of FDASIA
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) of the
FD&C Act must be ``valid scientific evidence,'' as defined in section
513(a)(3) 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 Manufacturers
Association v. FDA, 766
[[Page 34624]]
F.2d 592 (D.C. 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
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.
II. Regulatory History of the Device
FDA published a proposed order to reclassify this device in the
Federal Register of January 14, 2013 (78 FR 2647) (the ``proposed
order''). As discussed in the proposed order, the Agency originally
issued a final rule classifying all endosseous dental implants (without
distinguishing based on geometry) into class III (52 FR 30082, August
12, 1987). After later consideration by a reclassification panel, root-
form endosseous dental implants were reclassified into class II in a
final rule issued on May 12, 2004 (69 FR 26302), but blade-form
endosseous dental implants remained in class III.
After consideration of available information on blade-form
endosseous dental implants, the proposed order indicated that FDA
believed these devices could also be down classified to class II,
subject to the identified special controls. As required by section
513(e)(1) of the FD&C Act, on July 18, 2013, FDA also convened a
meeting of the Dental Products Panel (the Panel) to consider the
existing valid scientific evidence to support reclassification of
blade-form endosseous dental implants into class II.
The Panel discussed and agreed that the risks to health for this
device were adequately captured as presented by FDA. The Panel
deliberations included discussion of whether the risk of bone loss is
higher for blade-form dental implants as compared to root-form dental
implant devices. The Panel also discussed the technique-sensitive
nature of this device and expressed a concern that additional training,
which may not be found in the current curriculum for dental schools, is
needed prior to the use of this device to address the identified risks
to health.
The Panel agreed that the proposed special controls were reasonable
to mitigate the identified risks to health but recommended the device
labeling include specific patient selection criteria and
recommendations for training and education requirements for clinicians
using this device. The Panel recommended that companies marketing this
device ensure that device-specific training is available to clinicians.
The Panel also recommended clinical data as a special control for the
purpose of capturing failure rates and adverse event detection.
The special controls as previously proposed by FDA included
documented clinical experience for effective use and observed adverse
events which addresses the recommendations for patient selection
criteria, and failure rate and adverse event detection. Additionally,
the special controls include patient labeling which must contain
instructions for reporting complications. The patient labeling will
also address the concern for failure rate and adverse event detection.
To address the Panel's concern related to recommendations for training
and education requirements, FDA has added a special control for the
device labeling to include qualifications and training requirements for
clinicians using this device.
The Panel concluded that general controls alone are not sufficient
due to the identified risks to health; however, special controls, in
combination with the general controls, can be sufficient to assure the
safety and effectiveness of blade-form endosseous dental implants. The
Panel agreed that this device should be reclassified into class II
(special controls).
III. Public Comments in Response to the Proposed Order
In response to the proposed order, FDA received two comments from
practicing clinicians. Both of the comments supported reclassification
of the devices into class II, and described positive clinical
experience regarding the safety and effectiveness of the device. FDA
agrees with the comments.
IV. The Final Order
Under section 513(e) of the FD&C Act, FDA is adopting its findings
as published in the preamble to the proposed order. FDA is issuing this
final order to reclassify the blade-form endosseous dental implant from
class III to class II and to establish special controls. Following the
effective date of this final order, firms marketing blade-form
endosseous dental implants will need either to: (1) Comply with the
particular mitigation measures set forth in the special controls 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.
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 blade-form endosseous implants; and therefore, this
device type is not exempt from premarket notification requirements.
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 establishes special controls that refer to
previously approved collections of information found in other 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 21 CFR 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;
[[Page 34625]]
and the collections of information under 21 CFR part 801 have been
approved under OMB control number 0910-0485.
VII. 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 21 CFR 872.3640 related to the classification of
blade-form endosseous implants as class III devices and codifying the
reclassification of blade-form endosseous 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 872.3640 is amended by revising paragraph (a) and (b)(2) to
read as follows:
Sec. 872.3640 Endosseous dental implant.
(a) Identification. An endosseous dental implant is a prescription
device made of a material such as titanium or titanium alloy that is
intended to be surgically placed in the bone of the upper or lower jaw
arches to provide support for prosthetic devices, such as artificial
teeth, in order to restore a patient's chewing function.
(b) * * *
(2) Classification. Class II (special controls). The device is
classified as class II if it is a blade-form endosseous dental implant.
The special controls for this device are:
(i) The design characteristics of the device must ensure that the
geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated
physiological conditions to demonstrate maximum load (endurance limit)
when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to
demonstrate corrosion potential of each metal or alloy, couple
potential for an assembled dissimilar metal implant system, and
corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the
device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the
technological features, how the device should be used in patients,
detailed surgical protocol and restoration procedures, relevant
precautions and warnings based on the clinical use of the device, and
qualifications and training requirements for device users including
technicians and clinicians;
(viii) Patient labeling must contain a description of how the
device works, how the device is placed, how the patient needs to care
for the implant, possible adverse events and how to report any
complications; and
(ix) Documented clinical experience must demonstrate safe and
effective use and capture any adverse events observed during clinical
use.
Dated: June 12, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-14216 Filed 6-17-14; 8:45 am]
BILLING CODE 4164-01-P