[Federal Register Volume 67, Number 93 (Tuesday, May 14, 2002)]
[Proposed Rules]
[Pages 34416-34420]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-12041]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 872
[Docket No. 02N-0114]
Dental Devices; Reclassification of Root-Form Endosseous Dental
Implants and Endosseous Dental Implant Abutments
Agency: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to
reclassify from class III to class II root-form endosseous dental
implants intended to be surgically placed in the bone of the upper or
lower arches to provide support for prosthetic devices, such as
artificial teeth, in order to restore the patient's chewing function.
FDA is also proposing to reclassify endosseous dental implant
abutments, which are separate components that are attached to the
implant and intended to aid in prosthetic rehabilitation from class III
to class II. This reclassification is being proposed on the Secretary
of Health and Human Services (the Secretary's) own initiative based on
new information. The agency 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 SMDA), and the Food and Drug Administration
Modernization Act of 1997 (FDAMA). Elsewhere in this issue of the
Federal Register, FDA is publishing a notice of availability of a draft
guidance document that would serve as the special control if this
proposal becomes final.
DATES: Submit written or electronic comments by August 12, 2002. See
section XIII of this document for the proposed effective date of a
final rule based on this document.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.
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-
8879.
SUPPLEMENTARY INFORMATION:
I. Background (Regulatory Authorities)
The act (21 U.S.C. 301 et seq.), as amended by the 1976 amendments
(Public Law 94-295), the SMDA (Public Law 101-629) and FDAMA (Public
Law 105-115), 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, devices that were in commercial
distribution before May 28, 1976 (the date of enactment of the 1976
amendments), 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 classified
automatically by statute (section 513(f) of the act) into class III
without any FDA rulemaking process. Those devices remain in class III
and require premarket approval, unless and until: (1) The device is
reclassified into class I or II; (2) FDA issues an order classifying
the device into class I or II in accordance with new section 513(f)(2)
of the act, as amended by FDAMA; or (3) FDA issues an order finding the
device to be substantially equivalent, under section 513(i) of the act,
to a predicate device that does not require premarket approval. The
agency determines whether new devices are substantially equivalent to
previously offered devices by means of premarket notification
procedures in section 510(k) of the act (21 U.S.C. 360(k)) and 21 CFR
part 807 of the regulations.
A preamendments device that has been classified into class III may
be marketed, by means of premarket notification procedures, without
submission of a premarket approval application (PMA) until FDA issues a
final regulation under section 515(b) of the act (21 U.S.C. 360e(b))
requiring premarket approval.
Reclassification of classified preamendments devices is governed by
section 513(e) of the act. This section provides that FDA may, by
rulemaking, reclassify a device (in a proceeding that parallels the
initial classification proceeding) based upon ``new information.'' The
reclassification can be initiated by FDA or by the petition of an
interested person. The term ``new information,'' as used in section
513(e) of the 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 at
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, 389-91 (D.D.C. 1991)), or in light of changes in
``medical science.'' (See Upjohn v. Finch, supra, 422 F.2d at 951.)
Regardless of whether data before the agency are past or new data, the
``new information'' to support reclassification under section 513(e) of
the act must be ``valid scientific evidence,'' as defined in section
513(a)(3) of the act and 21 CFR 860.7(c)(2). (See, e.g., General
Medical
[[Page 34417]]
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. For the purpose of
reclassification, 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.,
nonpublic information in a pending PMA. (See section 520c of the act
(21 U.S.C. 360j(c).)
II. Regulatory History of the Device
In the Federal Register of August 12, 1987 (52 FR30082), FDA issued
a final rule classifying endosseous implants into class III (21 CFR
872.3640). The preamble to the proposal to classify the device (45 FR
85962, December 30, 1980) included the recommendation of the Dental
Devices Panel (the Panel) regarding the classification of the device.
The Panel's recommendation included a summary of the reasons the device
should be subject to premarket approval and identified certain risks to
health presented by the device. The Panel also recommended under
section 513(c)(2)(A) of the act that a high priority for the
application of section 515 of the act be assigned to the endosseous
dental implant.
In the Federal Register of January 6, 1989 (54 FR 550 at 551), FDA
issued a notice of intent to initiate proceedings to require premarket
approval of 31 preamendments class III devices assigned a high priority
by FDA for application of premarket approval requirements. Among other
things, the notice described the factors FDA takes into account in
establishing priorities for initiating proceedings under section 515(b)
of the act for issuing final rules requiring that preamendments class
III devices have approved PMAs or declared completed product
development protocols (PDP)s. Using those factors, FDA declared that
the endosseous implant, identified in 21 CFR 872.3640, had a high
priority for initiating a proceeding to require premarket approval.
Accordingly, FDA began a rulemaking proceeding to require that
endosseous implants have an approved PMA or a PDP that has been
declared completed.
In the Federal Register of December 7, 1989 (54 FR 50592), FDA
issued a proposed rule to require the filing of a PMA or a notice of
completion of a PDP for the endosseous implant. In accordance with
section 515(b)(2)(A) of the act, the agency summarized its proposed
findings with respect to the degree of risk of illness or injury
designed to be eliminated or reduced by requiring the device to meet
premarket approval requirements, and the benefits to the public from
the use of the device. The proposal also provided an opportunity for
interested persons to comment on the proposed rule and to request a
change in the classification of the device based on new information
relevant to its classification. The period for requesting a change in
the classification of the device closed on December 22, 1989. The
period for commenting on the proposed rule closed on February 5, 1990.
On December 12, 1989, FDA received a petition from the Dental
Implant Manufacturers of America (DIMA) requesting a change in the
classification of the root-form (i.e., screw, basket, solid and hollow
cylinder types) and blade-form endosseous dental implants from class
III to class II. The petition was limited to one-stage endosseous
implants and the first stage component of the two-stage implant system.
The petition's request included implants composed of commercially pure
titanium, titanium alloy (Ti-6Al-4V), ceramic single crystal aluminum
oxide, and ceramic, polycrystalline alumina. After a number of
exchanges between FDA and DIMA to resolve several deficiencies, FDA
referred the petition to the Panel for its recommendation on the
requested change in classification. The Panel met on October 24, 1991,
and voted to deny DIMA's petition (Ref. 1).
Based on information provided by FDA for the October 24, 1991
meeting, the Panel did recommend that screw-type root-form endosseous
dental implants be reclassified to class II. The Panel stated that
special controls would not be adequate to control some of the risks for
other types of endosseous dental implants and recommended that all
nonscrew-types remain in class III. In the years following this
recommendation, additional clinical data have been reviewed by FDA and
the agency believes all root-form endosseous dental implants can be
reclassified.
In accordance with section 513(e) of the act and 21 CFR
860.130(b)(2), based on new information with respect to the device,
FDA, on its own initiative, is proposing to reclassify the root-form
endosseous dental implant from class III to class II when intended to
be surgically placed in the bone of the upper or lower arches to
provide support for prosthetic devices, such as artificial teeth, in
order to restore the patient's chewing function. FDA is further
proposing to reclassify endosseous dental implant abutments from class
III to class II. Endosseous dental implants, other than root-form,
remain in class III and will require the filing of a PMA or PDP at a
future date.
The Panel met again on November 4, 1997, with a continuation of the
meeting on January 13, 1998. Based on new, publicly available
information provided by FDA, the Panel recommended that all root-form
endosseous dental implants and endosseous dental implant abutments be
reclassified from class III to class II. The Panel believed that class
II with special controls would provide reasonable assurance of safety
and effectiveness.
III. Device Description
An endosseous dental implant is a device made of titanium or
titanium alloy and is uncoated, or coated with titanium or
hydroxyapatite, 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 implants are used to attach either
removable or fixed prostheses (crowns, bridges, partial removable
dentures, or complete removable dentures) and are inserted into either
the maxillary or mandibular alveolar ridge.
Endosseous dental implants can be defined as a one-stage or two-
stage implant system. These may be loaded after a period of healing or,
in some patients for some indications, they may be loaded immediately.
Endosseous dental implants can be further generically grouped into four
geometrically distinct types: Basket, screw, solid cylinder, and hollow
cylinder. These four groups are known as ``root-form'' implants.
Several other geometrical types of implants have been marketed that do
not fall within the description of one of these four types and those
types are not root-form implants. FDA is proposing to change the
classification of only the root-form types.
Endosseous dental implant abutments are premanufactured prosthetic
components directly connected to the endosseous implant and are used as
an aid for prosthetic rehabilitation.
IV. Proposed Reclassification
Although the Secretary is proposing reclassification on his own
initiative, the agency provided new information to the Panel and asked
for its recommendation regarding the reclassification of the devices.
In a public meeting on January 13, 1998, the Panel unanimously
recommended that the root-form endosseous dental implant
[[Page 34418]]
be reclassified from class III to class II. The Panel believed that
class II with a special control guidance document, which includes
references to relevant voluntary consensus standards and gives guidance
on labeling, would provide reasonable assurance of safety and
effectiveness.
The Panel also recommended that endosseous implant abutments be
reclassified from class III to class II. They recommended a separate
classification from the root-form endosseous implants because the
abutments are not considered implants. The Panel believed that class II
with a special control guidance document that references relevant
voluntary consensus standards would provide reasonable assurance of the
safety and effectiveness of the device.
V. Risks to Health
When endosseous dental implants were classified into class III (52
FR 30082, August 12, 1987), the Panel and FDA identified several risks
associated with endosseous dental implants for prosthetic attachment,
including local soft tissue degeneration, hyperplasia, progressive bone
resorption, exfoliation, local and systemic infection (including long
term bacterial infection), damage to existing dentition, implant
mobility, implant integrity, infectious endocarditis, paresthesia,
perforation of the maxillary sinus, and perforation of the labial and
lingual alveolar plates. Although the existence of the risks was well
documented in numerous books and articles, the rate of occurrence was
poorly documented.
Although abutment integrity was not discussed as a specific risk at
the 1987 Panel meeting, FDA believes that this risk is a component of
implant integrity and, therefore, we have included abutment integrity
as a risk associated with endosseous dental implant abutments.
Since the classification of the device, additional data and
information became available. Based on a review of the new data and
information, the Panel, during an open public meeting on October 24,
1991, identified certain risks (parasthesia, perforation of the
maxillary sinus, perforation of the labial and lingual alveolar plates,
infectious endocarditis and implant integrity), which had only been
addressed for screw type implants by clinical studies. Therefore, they
believed that special controls would not adequately address these
concerns for all implants. They recommended only the screw type be
reclassified into class II (Ref. 1).
At the same meeting, the Panel concluded that the remaining risks
of local soft tissue degeneration, hyperplasia, progressive bone
resorption, exfoliation, local and systemic infection (including long-
term bacterial infection), damage to existing dentition, and implant
mobility had been addressed by clinical studies for all types of dental
implants.
Although in 1991 the Panel stated that special controls could not
adequately address the concern of implant integrity, they also stated
that chemical and physical characterization and mechanical testing
could partially control this risk with respect to fracture.
When the Panel considered new information, at the November 4, 1997,
and January 13, 1998, meetings, they concluded that several published
clinical and animal studies (Refs. 4, 5, 6, 7, 8, and 9) showed that
the occurrence and incidence of the risks discussed at the 1991 Panel
meeting are now well known and are found to be low for all root-form
devices and dental implant abutment devices (Refs. 2 and 3).
On the basis of the new clinical studies and the Panel's two
recommendations, FDA now believes that the root-form endosseous dental
implants and endosseous dental implant abutments do not present a
potential unreasonable risk to public health, and that special controls
would provide reasonable assurance of the safety and effectiveness of
the devices.
VI. Summary of Reasons for Reclassification
After considering the new information and the Panel's
recommendations, FDA believes that general controls are not sufficient
to provide reasonable assurance of the safety and effectiveness of the
device. FDA believes that the endosseous dental implants and endosseous
dental implant abutments should be reclassified into class II because
special controls, in addition to general controls, would provide
reasonable assurance of the safety and effectiveness of the devices,
and there is now sufficient information to establish special controls
to provide such assurance.
VII. Summary of Data Upon Which the Recommendation is Based
In addition to the potential risks to health of endosseous dental
implants and endosseous dental implant abutments described in section V
of this document, there is reasonable knowledge of the benefits of the
device (Refs. 10 and 11). The devices provide increased chewing
function and better appearance, resulting in an improved quality of
patient life. Based on the available information, FDA believes the
special control discussed in section VIII of this document is capable
of providing reasonable assurance of the safety and effectiveness of
the devices with regard to the identified risks to health of the
device.
VIII. Special Controls
In addition to general controls, FDA believes that the guidance
document entitled ``Class II Special Controls Guidance Document: Root-
form Endosseous Dental Implants and Abutments; Draft Guidance for
Industry and FDA'' is an adequate special control to address the
potential risks to health described for the root-form endosseous dental
implants and endosseous dental implant abutments.
The guidance document would indicate when clinical data are
appropriate and what engineering testing is needed. It will reference
voluntary consensus standards that are relevant for these devices. It
also will provide device specific labeling guidance. FDA believes that
adherence to the guidance document would control implant and abutment
fracture by providing guidance and reference to methodologies for
chemical and physical characterization and mechanical testing.
To receive a copy of ``Class II Special Controls Guidance Document:
Root-form Endosseous Dental Implants and Abutments; Draft Guidance for
Industry and FDA'' via fax machine, call CDRH Facts-on-Demand system at
800-899-0381, or 301-827-0111 from a touch-tone telephone. Press 1 to
access the system. At the second voice prompt, press 2, and then enter
the document number (1389) followed by the pound sign (#). Then follow
the remaining voice prompts to complete your request. The draft
guidance is also available on the Internet and may be accessed at
http://www.fda.gov/cdrh and at http://www.fda.gov/ohrms/dockets/defaults.htm.
IX. FDA's Tentative Findings
FDA believes the root-form endosseous dental implants and
endosseous dental implant abutments should be classified into class II
because special controls, in addition to general controls, provide
reasonable assurance of the safety and effectiveness of the device, and
there is sufficient information to establish special controls to
provide such assurance.
X. Environmental Impact
The agency has determined under 21 CFR 25.34(b) that this proposed
reclassification action is of a type that
[[Page 34419]]
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.
XI. Analysis of Impacts
FDA has examined the impacts of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612) (as
amended by subtitle D of the Small Business Regulatory Fairness Act of
1996 (Public Law 104-121)), 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 and,
when regulation is necessary, to select regulatory approaches that
maximize net benefits (including potential economic, environmental,
public health and safety, and other advantages; distributive impacts;
and equity). The agency believes that this proposed rule is consistent
with the regulatory philosophy and principles identified in the
Executive order. In addition, the proposed rule is not a significant
regulatory action as defined by the Executive order and so 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 these devices of the cost of
complying with premarket approval requirements in section 515 of the
act. Because reclassification will reduce regulatory cost with respect
to these devices, it will impose no significant economic impact on any
small entities, and it may permit small potential competitors to enter
the marketplace by lowering their costs. The agency therefore certifies
that this reclassification action, as issued, if finalized, will not
have a significant economic impact on a substantial number of small
entities. In addition, this reclassification action will not impose
costs of $100 million or more on either the private sector or State,
local, and tribal governments in the aggregate, and therefore a summary
statement or analysis under section 202(a) of the Unfunded Mandates
Reform Act of 1995 is not required.
XII. Paperwork Reduction Act of 1995
FDA tentatively concludes that this proposed rule contains no
information that is subject to review by the Office of Management and
Budget under the Paperwork Reduction Act of 1995. The special controls
do not require the respondent to submit additional information.
XIII. Submission of Comments and Proposed Dates
Interested persons may submit to the Dockets Management Branch (see
ADDRESSES) written or electronic comments regarding this proposal by
August 12, 2002. Two copies of any comments are to be submitted, except
that individuals may submit one copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. Received comments may be seen in the Dockets Management
Branch between 9 a.m. and 4 p.m., Monday through Friday. FDA proposes
that any final regulation based on this proposal become effective 30
days after its date of publication in the Federal Register.
XIV. References
The following references have been placed on display in the Dockets
Management Branch (see ADDRESSES) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. Transcript of the Dental Products Panel Meeting, October 24,
1991.
2. Transcript of the Dental Products Panel Meeting, November 4,
1997.
3. Transcript of the Dental Products Panel Meeting, January 13,
1998.
4. Buser, D., et al., ``Influence of Surface Characteristics on
Bone Integration of Titanium Implants. A Histomorphometric Study in
Miniature Pigs,'' Journal of Biomedical Materials Research, vol. 25,
pp. 889-902, 1991.
5. Carr, A. B., et al., ``Reverse Torque Failure of Screw-shaped
Implants in Baboons: Baseline Data for Abutment Torque
Application,'' International Journal of Oral and Maxillofacial
Implants, vol. 10, pp. 167-174, 1995.
6. Adell, R., et al., ``A Long-term Follow-up Study of
Osseointegrated Implants in the Treatment of Totally Edentulous
Jaws,'' International Journal of Oral and Maxillofacial Implants,
vol. 5, pp. 347-359, 1990.
7. O'Roark, W. L., ``Research Report: Improving Implant Survival
Rates by Using a New Method of at Risk Analysis,'' International
Journal of Oral Implantology, vol. 8, No. 1, pp. 31-57, 1991.
8. Buser, D., et al., ``Long Term Evaluation of Nonsubmerged ITI
Implants. Part 1: 8-year Life Table Analysis of a Prospective Multi-
center Study With 2359 Implants,'' Clinical Oral Implants Research,
vol. 8, pp. 161-172, 1997.
9. Block, M. S., J. N. Kent, ``Cylindrical HA-coated Implants--
8-year Observations,'' Compendium of Continuing Education Dentistry,
Supplement 15, pp. 526-532, 1993.
10. Proceedings of the 1996 World Workshop in Perisontics,
Annals of Periodontology, vol. 1, No. 1, pp. 707-820, 1996.
11. Misch, C. E., Contemporary Implant Dentistry, St. Louis, MO:
Mosby, pp. 89-118, 1999.
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
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.
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 for
prosthetic rehabilitation.
(b) Classification. Class II (special controls). The special
control for this device is the FDA guidance document entitled ``Class
II Special Controls Guidance Document: Root-form Endosseous Dental
Implants and Abutments; Final Guidance for Industry and FDA.''
3. Section 872.3640 is revised in subpart D 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 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 special
control for this device is the FDA guidance document entitled ``Class
II Special Controls Guidance Document: Root-form Endosseous Dental
Implants and Abutments; Final Guidance for Industry and FDA.''
(2) Class III for endosseous dental implants other than the root-
form.
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established for the requirement for premarket
approval for the devices described in paragraph (b)(2) of this section.
See Sec. 872.3 for the effective dates of requirement for premarket
approval.
[[Page 34420]]
Dated: April 23, 2002.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-12041 Filed 5-13-02; 8:45 am]
BILLING CODE 4160-01-S