[Federal Register Volume 78, Number 9 (Monday, January 14, 2013)]
[Proposed Rules]
[Pages 2647-2650]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-00388]


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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: Proposed order.

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SUMMARY: The Food and Drug Administration (FDA) is proposing 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 proposing to revise the 
classification of blade-form endosseous dental implants.

DATES: Submit either electronic or written comments on this proposed 
order by April 15, 2013. See section XI of this document for the 
proposed effective date of a final order based on this proposed order.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2012-
N-0677, by any of the following methods:

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-0677 for this rulemaking. 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 Docket 
No. FDA-2012-N-0677 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: Melissa Burns, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1646, Silver Spring, MD 20993, 301-796-5616, 
melissa.burns@fda.hhs.gov.

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 
(Public Law 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), establish 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 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 (126 
Stat. 1056) amended section 513(e) of the FD&C Act changing the process 
for reclassifying a preamendments device from rulemaking to an 
administrative order.

[[Page 2648]]

    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 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 regulatory action where the 
reevaluation is made in light of newly available regulatory authority 
(see Bell v. Goddard, supra, 366 F.2d at 181; Ethicon, Inc. v. FDA, 762 
F.Supp. 382, 389-391 (D.D.C. 1991)) or in light of changes in ``medical 
science.'' (See Upjohn v. Finch, supra, 422 F.2d at 951). Whether data 
before the Agency are past 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 Assoc. v. FDA, 766 F.2d 592 (D.C. Cir.), 
cert. denied, 474 U.S. 1062 (1985).)
    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: Publication of 
a proposed order in the Federal Register, a meeting of a device 
classification panel described in section 513(b) of the FD&C Act; and 
consideration of comments to a public docket.
    FDAMA added a new 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

    On December 30, 1980 (45 FR 86025), FDA published a proposed rule 
for classification of endosseous dental implants (without 
distinguishing implants based on geometry) as class III requiring 
premarket approval. The panel recommended class III because the device 
is implanted in the body and presents a potential unreasonable risk of 
illness or injury including risks of abnormal spontaneous pain due to 
nerve impingement and a risk of perforation of the lingual and labial 
bony plates of the upper and lower jaws. On August 12, 1987 (52 FR 
30082), a final rule was published for endosseous dental implants 
(again without distinguishing implants based on geometry) classifying 
these devices as class III. On December 7, 1989 (54 FR 50592), FDA 
published a proposed rule to require PMA submissions for all dental 
implants. A reclassification petition was subsequently submitted 
requesting reclassification of dental implants.
    FDA held a reclassification panel meeting on October 24, 1991, and 
the panel voted to deny the reclassification petition. At the request 
of FDA, additional panel meetings were held on November 4, 1997, and 
January 13, 1998, during which FDA presented new information regarding 
root-form endosseous dental implants. During the January 1998 panel 
meeting, the panel stated that sufficient clinical information was 
presented to the panel to justify reclassification of root-form 
implants, implants with special retention features, and temporary 
implants, as class II (special controls) requiring a 510(k) premarket 
notification. However, the panel also stated that sufficient evidence 
had not yet been presented to reclassify blade-form endosseous dental 
implants to class II.
    On May 14, 2002 (67 FR 34416), and May 12, 2004 (69 FR 26302), 
proposed and final rules respectively were issued reclassifying only 
root-form implants into class II. Blade-form endosseous dental implant 
remained class III.
    In 2009, FDA published an order under sections 515(i) and 519 of 
the FD&C Act (21 U.S.C. 360i) for the submission of information on 
blade-form endosseous dental implants (74 FR 16214, April 9, 2009). In 
response to that order, FDA received information from one device 
manufacturer; however, the information was related to other types of 
dental implants and was not relevant for this proposed rule.

III. Device Description

    The blade-form endosseous dental implant is a device placed into 
the maxilla or mandible and composed of biocompatible material, such as 
titanium alloy or commercially pure (c.p.) titanium, with sufficient 
strength to support a dental restoration, such as a crown, bridge, or 
denture, intended for the purpose of replacing tooth (or teeth) roots 
and extending a support post through the gingival tissue into the oral 
cavity to restore chewing function. The blade-form implants are either 
one-piece or two-piece implants designed with one to three cylindrical 
abutment posts extending from the coronal aspect of the blade through 
the soft tissue and into the oral cavity. For the two-piece design, the 
separate abutment post is retained to the blade implant with a screw.
    The blade-form implant is generally a rectangular shape or rounded 
corner rectangle shape (in the mesio-distal plane) with a narrow 
tapered (narrow at the apical edge) edge (in the bucco-lingual plane) 
similar in shape to a razor blade. Other blade designs, such as square, 
V-shaped, and triangles have also been used. The blade generally 
contains open vents of various shapes and various sizes.

IV. Proposed Reclassification

    FDA is proposing that the device subject to this proposal be 
reclassified from class III to class II. In this proposed order, the 
Agency has identified special controls under section 513(a)(1)(B) of 
the FD&C Act that, together with general controls applicable to the 
devices, would provide reasonable assurance of their safety and 
effectiveness. FDA believes that the identified special controls in 
this proposed order, if finalized, together with general controls 
applicable to the device, would provide reasonable assurance of safety 
and

[[Page 2649]]

effectiveness. Absent the special controls identified in this proposed 
order, general controls applicable to the device are insufficient to 
provide reasonable assurance of the safety and effectiveness of the 
device.
    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 devices and taking into account the public health benefit of the 
use of the device and the nature and known incidence of the risk of the 
device, FDA, on its own initiative, is proposing to reclassify this 
preamendments class III device into class II. FDA believes that this 
new information is sufficient to demonstrate that the proposed special 
controls can effectively mitigate the risks to health identified in the 
next section, and that these special controls, together with general 
controls, will provide a reasonable assurance of safety and 
effectiveness for blade-form endosseous dental implant devices.
    FDA has also considered blade-form endosseous dental implant 
devices in accordance with the reserved criteria set forth in section 
513(a) of the FD&C Act and decided that the device does require 
premarket notification. The Agency does not intend to exempt this 
proposed class II device from premarket notification (510(k)) 
submission as allowed under section 510(m) of the FD&C Act.

V. Risks to Health

    After considering available information, including the 
recommendations of the advisory committees (panels) for the 
classification of these devices, FDA has evaluated the risks to health 
associated with the use of blade-form endosseous dental implant devices 
and determined that the following risks to health are associated with 
its use:
     Local tissue or existing dentition degeneration: Localized 
tissue and existing dentition degeneration may be caused by endosseous 
implants due to excessive mobility, loss of integration, 
incompatibility of device components, or structural failure of the 
device.
     Pain: Nerve impingement by the device may cause pain.
     Bone or nerve damage: Improper design or use of the device 
may cause injury during surgery related to sinus perforation, alveolar 
plate perforation, or nerve damage resulting in transient or chronic 
pain/facial nerve paresis.
     Infection: Implantable devices may introduce 
microorganisms that may cause local or systemic infections.
     Adverse tissue reaction: Inadequate tissue compatibility 
of the materials used in this device could cause an immune reaction.
     Migration or thermal injury: Incompatibility with magnetic 
resonance imaging may cause the device to migrate or heat.

VI. Summary of Reasons for Reclassification

    If properly manufactured and used, blade-form endosseous dental 
implants can help restore the patient's chewing function by replacing 
tooth roots and extending a support post through the gingival tissue 
into the oral cavity in order to support a dental restoration, such as 
a crown, bridge, or denture. FDA believes that blade-form endosseous 
dental implant devices should be reclassified into class II because 
special controls, together with general controls, can be established to 
provide reasonable assurance of the safety and effectiveness of the 
device, and because general controls themselves are insufficient to 
provide reasonable assurance of its safety and effectiveness. In 
addition, there is now adequate effectiveness information sufficient to 
establish special controls to provide such assurance.

VII. Summary of Data Upon Which the Reclassification Is Based

    Since the time of the panel recommendation, sufficient evidence has 
been developed to support a reclassification of blade-form endosseous 
dental implants to class II with special controls. FDA has been 
reviewing these devices for many years and their risks are well known. 
A review of the applicable clinical literature indicates that the 
device has a high success rate (remaining implanted/not removed) and 
that few relevant adverse events have been reported in the case of 
these devices or related devices suggesting that the device has a high 
long-term safety profile. FDA believes that the special controls 
identified in this proposed order, if finalized, together with general 
controls, can provide a reasonable assurance of the safety and 
effectiveness of blade-form endosseous dental implants.

VIII. Proposed Special Controls

    FDA believes that the following special controls, together with 
general controls, are sufficient to mitigate the risks to health 
described in section V of this document:
     The design characteristics of the device must ensure that 
the geometry and material composition are consistent with the intended 
use;
     Mechanical performance (fatigue) testing under simulated 
physiological conditions to demonstrate maximum load (endurance limit) 
when the device is subjected to compressive and shear loads;
     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;
     The device must be demonstrated to be biocompatible;
     Sterility testing must demonstrate the sterility of the 
device;
     Performance testing to evaluate the compatibility of the 
device in a magnetic resonance (MR) environment;
     Labeling must include a clear description of the 
technological features, how the device should be used in patients, 
detailed surgical protocol and restoration procedures, and relevant 
precautions and warnings based on the clinical use of the device;
     Patient labeling must contain a description of how the 
devices 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
     Documented clinical experience must demonstrate safe and 
effective use and capture any adverse events observed during clinical 
use.
    Blade-form endosseous dental implants are prescription devices 
restricted to patient use only upon the authorization of a practitioner 
licensed by law to administer or use the device. (Proposed 21 CFR 
872.3640(a); see section 520(e) of the FD&C Act and 21 CFR 801.109 
(Prescription devices)). Prescription-use restrictions are a type of 
general controls authorized under section 520(e) of the FD&C Act and 
defined as a general control in section 513(a)(1)(A)(i) of the FD&C 
Act; and under 21 CFR 807.81, the device would continue to be subject 
to 510(k) notification requirements.

IX. 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.

X. Paperwork Reduction Act of 1995

    This proposed rule 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

[[Page 2650]]

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.

XI. Proposed Effective Date

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

XII. Comments

    Interested persons may submit either electronic comments regarding 
this document 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.

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, 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 872.3640 is amended by revising paragraphs (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) 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, and relevant 
precautions and warnings based on the clinical use of the device;
    (viii) Patient labeling must contain a description of how the 
devices 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: January 4, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-00388 Filed 1-11-13; 8:45 am]
BILLING CODE 4160-01-P