[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]



Food and Drug Administration

21 CFR Part 872

[Docket No. FDA-2012-N-0677]

Dental Devices; Reclassification of Blade-Form Endosseous Dental 

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.


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].


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 
    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:


1. The authority citation for 21 CFR part 872 continues to read as 

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

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 

    Dated: June 12, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-14216 Filed 6-17-14; 8:45 am]