[Federal Register: May 12, 2004 (Volume 69, Number 92)]
[Rules and Regulations]
[Page 26302-26304]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12my04-3]
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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.
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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