[Federal Register Volume 69, Number 92 (Wednesday, May 12, 2004)]
[Rules and Regulations]
[Pages 26302-26304]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-10748]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 872

[Docket No. 2002N-0114]


Dental Devices; Reclassification of Root-Form Endosseous Dental 
Implants and Endosseous Dental Implant Abutments

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is reclassifying root-
form endosseous dental implants and endosseous dental implant abutments 
from class III to class II (special controls). Root-form endosseous 
dental implants are 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 the patient's chewing 
function. Endosseous dental implant abutments are separate components 
that are attached to the dental implant and intended to aid in 
prosthetic rehabilitation. FDA is reclassifying these devices on its 
own initiative on the basis of new information. Elsewhere in this issue 
of the Federal Register, FDA is announcing the availability of the 
guidance document that will serve as the special control for these 
devices. FDA is taking this action under the Federal Food, Drug, and 
Cosmetic Act (the act), as amended by the Medical Device Amendments of 
1976 (the 1976 amendments), the Safe Medical Devices Act of 1990, the 
Food and Drug Administration Modernization Act of 1997, and the Medical 
Device User Fee and Modernization Act of 2002.

DATES: This rule is effective June 11, 2004.

FOR FURTHER INFORMATION CONTACT: Angela E. Blackwell, Center for 
Devices and Radiological Health (HFZ-480), Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-827-
5283.

SUPPLEMENTARY INFORMATION:

I. Background

    The act (21 U.S.C. 301 et seq.) established a comprehensive system 
for the regulation of medical devices intended for human use. Section 
513 of the act (21 U.S.C. 360c) established three categories (classes) 
of devices, depending on 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 act, FDA refers to devices that were in 
commercial distribution before May 28, 1976 (the date of enactment of 
the 1976 amendments), as ``preamendments devices.'' FDA classifies 
these devices after the agency initiates the following procedures: (1) 
Receives a recommendation from a device classification panel (an FDA 
advisory committee); (2) publishes the panel's recommendation for 
comment, along with a proposed regulation classifying the device; and 
(3) publishes a final regulation classifying the device. FDA has 
classified most preamendments devices under these procedures.
    FDA refers to devices that were not in commercial distribution 
before May 28, 1976, as ``postamendments devices.''

[[Page 26303]]

 These devices are classified automatically by statute (section 513(f) 
of the act) into class III without any FDA rulemaking process. The 
devices remain in class III and require premarket approval, unless FDA 
initiates the following procedures: (1) Reclassifies the device into 
class I or II; (2) issues an order classifying the device into class I 
or II in accordance with new section 513(f)(2) of the act; or (3) 
issues, under section 513(i) of the act, an order finding the device 
substantially equivalent to a predicate device that does not require 
premarket approval. As described in section 510(k) of the act (21 
U.S.C. 360(k)) and under part 807 of the regulations (21 CFR part 807), 
FDA determines whether new devices are substantially equivalent to 
previously offered devices by means of premarket notification 
procedures. Through premarket notification procedures, a person may, 
without submission of a premarket approval application (PMA), market a 
preamendments device that has been classified into class III until FDA 
issues a final regulation under section 515(b) of the act (21 U.S.C. 
360e(b)) requiring premarket approval.
    Section 513(e) of the act governs the reclassification of 
classified preamendments devices. This section provides that FDA may, 
by rulemaking, reclassify a device based on ``new information.'' Under 
section 513(e) of the act, FDA can initiate reclassification or an 
interested person can petition FDA to reclassify a preamendments 
device. The term ``new information,'' as used in section 513(e) of the 
act, includes information developed after the date of the device's 
original classification. This information could include a reevalution 
of the original data or information from the time of the device's 
original classification that was not presented, available, or 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 used by FDA 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, 389-91 
(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 FDA 
are past 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 act and Sec.  
860.7(c)(2) (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. When 
reclassifying a device, FDA can only consider valid scientific evidence 
that is publicly available. Publicly available information excludes 
trade secret and confidential commercial information, e.g., the 
contents of a pending PMA. (See section 520(c) of the act (21 U.S.C. 
360j(c).)

II. Regulatory History of the Device

    In the Federal Register of May 14, 2002 (67 FR 34416), FDA proposed 
to reclassify root-form endosseous dental implants and endosseous 
dental implant abutments from class III to class II (special controls). 
Root-form endosseous dental implants are 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 
the patient's chewing function. Endosseous dental implant abutments are 
separate components that are attached to the dental implant and 
intended to aid in prosthetic rehabilitation. Blade-form endosseous 
dental implants remain in class III and will require the filing of a 
PMA or product development protocol at a future date.
    Also in the Federal Register of May 14, 2002 (67 FR 34458), FDA 
announced the availability of a draft guidance document that FDA 
intended to serve as the special control for root-form endosseous 
dental implants and endosseous dental implant abutments, if FDA 
reclassified them. FDA gave interested persons until August 12, 2002, 
to comment on the proposed regulation and special controls draft 
guidance document. FDA received a total of five comments on the 
proposed regulation and draft guidance document.

III. Summary of Final Rule

    In accordance with Sec.  860.84(g)(2) of the regulations, FDA is 
reclassifying root-form endosseous dental implants and endosseous 
dental implant abutments into class II. FDA is revising the 
classification of endosseous implants to distinguish between root-form 
endosseous dental implants and blade-form endosseous dental implants. 
Root-form endosseous dental implants are characterized by four 
geometrically distinct types: Basket, screw, solid cylinder, and hollow 
cylinder. Blade-form endosseous dental implants are flat and have 
different surgical requirements. To ensure clarity, FDA is establishing 
a separate classification regulation for endosseous dental implant 
abutments (Sec.  872.3630 (21 CFR 872.3630)), because abutments are not 
implants. The guidance document entitled ``Class II Special Controls 
Guidance Document: Root-Form Endosseous Dental Implants and Endosseous 
Dental Implant Abutments'' will serve as the special control for both 
devices. Elsewhere in this issue of the Federal Register, FDA is 
announcing the availability of this guidance. Following the effective 
date of the final classification rule, any firm submitting a 510(k) 
premarket notification for these devices will need to address the 
issues covered in the special controls guidance document. However, the 
firm need only show that its device meets the recommendations of the 
guidance or in some other way provides equivalent assurances of safety 
and effectiveness.
    FDA believes that review of performance characteristics and 
labeling can ensure that acceptable levels of performance for both 
safety and effectiveness are addressed before marketing clearance. 
Persons who intend to market these devices must submit to FDA a 
premarket notification submission before marketing the devices.

IV. Analysis of Comments and FDA's Response

    FDA received a total of five comments on the proposed rule and the 
special controls guidance document. Four comments addressed 
reclassification. Three comments agreed with the reclassification of 
root-form endosseous dental implants from class III to class II. One 
comment stated that root-form endosseous dental implants should remain 
in class III because of the potential for initial contamination of an 
implant at placement. The comment believes that initial contamination 
of the implant may be a cause of oral infection resulting in the future 
loss of the implant. FDA believes that the quality system regulation 
requirements, a general control, along with the recommended mitigation 
measures for health risks specified in the special controls guidance 
document, address sterility issues adequately and provide reasonable 
assurance of safety and effectiveness. Therefore, FDA is codifying the 
reclassification of root-form endosseous dental implants by revising 
Sec.  872.3640.
    Three comments supported the reclassification of endosseous dental

[[Page 26304]]

implant abutments into class II. FDA is codifying the reclassification 
of endosseous dental implant abutments in a separate classification 
regulation (Sec.  872.3630). Elsewhere in this issue of the Federal 
Register, FDA is announcing the availability of the guidance document 
that will serve as the special control for both devices.

V. Environmental Impact

    FDA has determined under 21 CFR 25.34(b) that this reclassification 
action 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. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and 
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive 
Order 12866 directs agencies to assess all costs and benefits of 
available regulatory alternatives. If regulation is necessary, a 
regulatory agency must plot a course that maximizes net benefits 
(including potential economic, environmental, public health and safety, 
and other advantages; distributive impacts; and equity). FDA believes 
the final rule is consistent with the regulatory philosophy and 
principles identified in the Executive order. Additionally, as defined 
by the Executive order, the final rule does not constitute a 
significant regulatory action. As a result, the final rule is not 
subject to review under the Executive order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Reclassification of these devices from class III to 
class II will relieve all manufacturers of the devices of the cost of 
eventually complying with the premarket approval requirements in 
section 515 of the act. FDA expects that manufacturers of cleared root-
form endosseous dental implants and endosseous dental implant abutments 
will not have to take any additional action in response to this rule. 
Currently, manufacturers of endosseous dental implants and endosseous 
dental implant abutments must submit premarket notifications to FDA 
before marketing their devices. The guidance document reflects existing 
FDA practice in the review of these premarket notifications and will 
help expedite the review process for new manufacturers of these 
devices. Because reclassification will reduce the regulatory costs 
associated with these devices, it will impose no new burdens on 
manufacturers of these devices. In fact, it may permit small potential 
competitors to enter the marketplace by lowering their costs. The 
agency therefore certifies that this final rule will not have a 
significant economic impact on a substantial number of small entities. 
In addition, this rule will not impose costs of $100 million or more on 
either the private sector or State, local, and tribal governments in 
the aggregate. As a result, a summary statement of analysis under 
section 202(a) of the Unfunded Mandates Reform Act of 1995 is not 
required.

VII. Federalism

    FDA has analyzed the final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies conferring substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, FDA has concluded that the 
rule does not contain policies that have federalism implications as 
defined in the Executive order. As a result, a federalism summary 
impact statement is not required.

VIII. Paperwork Reduction Act of 1995

    FDA concludes that the final rule contains no collections of 
information. Therefore, clearance by the Office of Management and 
Budget, according to the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501-3520) is not required.

List of Subjects in 21 CFR Part 872

    Medical devices.

0
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 872.3630 is added to subpart D to read as follows:


Sec.  872.3630  Endosseous dental implant abutment.

    (a) Identification. An endosseous dental implant abutment is a 
premanufactured prosthetic component directly connected to the 
endosseous dental implant and is intended for use as an aid in 
prosthetic rehabilitation.
    (b) Classification. Class II (special controls). The guidance 
document entitled ``Class II Special Controls Guidance Document: Root-
Form Endosseous Dental Implants and Endosseous Dental Implant 
Abutments'' will serve as the special control. (See Sec.  872.1(e) for 
the availability of this guidance document.)

0
3. Section 872.3640 is revised to read as follows:


Sec.  872.3640   Endosseous dental implant.

    (a) Identification. An endosseous dental implant is a 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) Classification. (1) Class II (special controls). The device is 
classified as class II if it is a root-form endosseous dental implant. 
The root-form endosseous dental implant is characterized by four 
geometrically distinct types: Basket, screw, solid cylinder, and hollow 
cylinder. The guidance document entitled ``Class II Special Controls 
Guidance Document: Root-Form Endosseous Dental Implants and Endosseous 
Dental Implant Abutments'' will serve as the special control. (See 
Sec.  872.1(e) for the availability of this guidance document.)
    (2) Class III (premarket approval). The device is classified as 
class III if it is a blade-form endosseous dental implant.

    Dated: May 3, 2004.
Linda S. Kahan,
Center for Devices and Radiological Health.
[FR Doc. 04-10748 Filed 5-11-04; 8:45 am]
BILLING CODE 4160-01-S