[Federal Register Volume 63, Number 194 (Wednesday, October 7, 1998)]
[Proposed Rules]
[Pages 53859-53862]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-26816]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 872

[Docket No. 98N-0753]


Dental Products Devices; Reclassification of Endosseous Dental 
Implant Accessories

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to 
reclassify manually powered drill bits, screwdrivers, countertorque 
devices, placement and removal tools, laboratory pieces used for 
fabrication of dental prosthetics, trial abutments, and other manually 
powered endosseous dental implant accessories from class III to class 
I. These devices are intended to aid in the placement or removal of 
endosseous implants and abutments, prepare the site for placement of 
endosseous dental implants or abutments, aid in the fitting of 
endosseous implants or abutments, aid in the fabrication of dental 
prosthetics, and be used as an accessory with endosseous dental 
implants when tissue contact will last less than 1 hour. FDA also 
proposes to exempt these devices from premarket notification 
requirements. This reclassification is being proposed on the Secretary 
of Health and Human Services' own initiative based on new information. 
This action is being taken 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).

DATES: Submit written comments by January 5, 1999. FDA proposes that 
any final regulation based on this proposal become effective 30 days 
after its date of publication in the Federal Register.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

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, 301-443-
8879.

[[Page 53860]]

SUPPLEMENTARY INFORMATION:

I. Background (Regulatory authorities)

    The act, as amended by the 1976 amendments (Pub. L. 94-295), the 
SMDA (Pub. L. 101-629), and FDAMA (Pub. L. 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 
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 class 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 part 807 (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 
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.) 
Regardless of whether data before the agency are past or new data, the 
``new information'' upon which reclassification under section 513(e) of 
the act is based must consist of ``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 Co. v. FDA, 770 F.2d 214 (D.C. Cir. 1985); 
Contact Lens Association 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., the contents of a pending 
PMA. (See section 520(c) of the act (21 U.S.C. 360j(c)).) FDAMA added a 
new section 510(l) to the act. New section 510(l) of the act provides 
that a class I device is exempt from the premarket notification 
requirements under section 510(k) of the act, unless the device is 
intended for a use which is of substantial importance in preventing 
impairment of human health or it presents a potential unreasonable risk 
of illness or injury, hereafter these are referred to as ``reserved 
criteria.'' FDA has considered endosseous dental implant accessories in 
accordance with the reserved criteria and determined that the devices 
do not require premarket notification. Such an exemption permits 
manufacturers to introduce into commercial distribution generic types 
of devices without first submitting a premarket notification to FDA.

II. Regulatory History of the Device

    In the Federal Register of August 12, 1987 (52 FR 30082), FDA 
published a final rule (21 CFR 872.3640) classifying endosseous 
implants into class III. Endosseous dental implant accessories (drill 
bits, screwdrivers, countertorque devices, etc.), as accessories to 
endosseous implants, were also classified into class III (see section 
201(h) of the act (21 U.S.C. 321(h)). The preamble to the proposal to 
classify the endosseous implants (45 FR 85962, December 30, 1980) 
identified certain risks the Dental Products Panel (the Panel) believed 
were presented by the implants. These risks included tissue 
degeneration, pain, bone perforation, and infection. On December 12, 
1989, the Dental Implant Manufacturers Association (DIMA) submitted a 
petition requesting a change in the classification of certain 
endosseous implants from class III to class II. Subsequent to review of 
the petition and during a panel meeting (October 24, 1991), the Panel 
further identified paresthesia, perforation of the maxillary sinus, and 
the labia and lingual palates, and exfoliation as risks and voted to 
recommend denial of DIMA's petition. Additionally, FDA identified local 
and systemic infection and implant failure as significant risks 
associated with endosseous implants. However, none of these risks were 
directly related to the accessories.
    During subsequent panel meetings on November 4, 1997, and January 
13, 1998, the Panel, after reviewing safety and effectiveness data 
submitted by manufacturers at FDA's request, considered the 
reclassification of dental implants and abutments. The Panel 
recommended the reclassification of root form implants from class III 
to class II with special controls that include education, a 
precautionary statement regarding use in growing individuals 
(labeling), standards, guidance documents, and clinical trials. The 
Panel further recommended that blade implants remain in class III. 
Regarding abutments, the Panel recommended that premanufactured 
prosthetic components (abutments) which are connected directly to an 
implant be reclassified from class III to class II and codified 
separately. FDA intends to address the classification of dental 
implants and

[[Page 53861]]

premanufactured prosthetic components in a separate rulemaking.
    In accordance with section 513(e) of the act and 21 CFR 
860.130(a)(1), based on new information with respect to these devices, 
FDA, on its own initiative, is proposing to reclassify endosseous 
dental implant accessories from class III to class I when intended to 
aid in the placement or removal of endosseous dental implants and 
abutments, prepare the site for placement of endosseous dental implants 
and abutments, aid in the fitting of endosseous dental implants or 
abutments, aid in the fabrication of dental prosthetics, and be used as 
an accessory with endosseous dental implant when tissue contact will 
last less than 1 hour.

III. Device Description

    Endosseous dental implant accessories are manually powered devices 
intended to aid in the placement or removal of endosseous implants and 
abutments, prepare the site for placement of endosseous dental implants 
or abutments, aid in the fitting of endosseous dental implants or 
abutments, aid in the fabrication of dental prosthetics, and be used as 
an accessory with endosseous dental implants when tissue contact will 
last less than 1 hour. These devices include drill bits, screwdrivers, 
countertorque devices, placement and removal tools, and laboratory 
pieces used for fabrication of dental prosthetics and trial abutments. 
These devices are made from materials currently in use in endosseous 
implant dentistry.
    Some accessory devices that may be associated with endosseous 
dental implants may be classified under a different regulation. For 
example, drill bits for uses other than with implants are classified as 
dental burs (21 CFR 872.3240). Some other devices, when used for dental 
procedures other than with implants are considered dental hand 
instruments (21 CFR 872.4565). These burs and hand held instruments are 
currently class I devices and are exempt from the 510(k) procedures. 
When these dental burs and hand held instruments are used as 
accessories for endosseous dental implants, they now would be 
classified under proposed 21 CFR 872.3980. Under the proposal, these 
accessory devices would also be class I and exempt from the 510(k) 
procedures.

IV. Proposed Reclassification

    FDA is proposing that endosseous dental implants accessories 
intended to aid in the placement or removal of endosseous dental 
implants and abutments, prepare the site for placement of endosseous 
implants and abutments, aid in the fitting of endosseous dental 
implants or abutments, aid in the fabrication of dental prosthetics, 
and be used as an accessory with endosseous dental implants when tissue 
contact will last less than 1 hour should be reclassified from class 
III to class I. FDA believes that class I would provide reasonable 
assurance of safety and effectiveness. FDA also proposes that the 
devices be exempt from premarket notification requirements.

V. Risks to Health

    When endosseous implants were classified into class III (52 FR 
30082), the Panel and FDA identified several risks (tissue 
degeneration, pain, bone perforation, and infection) associated with 
them. Subsequent to the classification, additional data and information 
became available. Based on a review of the new data and information, 
other risks were identified. These ``other'' risks included local soft 
tissue degeneration and bone resorption, paresthesia, nerve 
impingement, perforation of the maxillary sinus, perforation of the 
labia and lingual palates, exfoliation, local and systemic infection, 
and implant failure. FDA believes that these risks associated with 
endosseous implants are not attributable in any significant way to the 
accessories used by the clinician to implant the device. FDA, 
therefore, believes there are minimal risks to health posed by the 
reclassification of these accessories.

VI. Summary of Reasons for the Reclassification

    FDA believes that endosseous dental implant accessories should be 
classified into class I because general controls would provide 
reasonable assurance of safety and effectiveness. Furthermore, FDA 
believes these accessories are exempt from 510(k) requirements under 
the act. FDAMA added a new section 510(l) to the act. New section 
510(l) of the act provides that a class I device is exempt from the 
premarket notification requirements under section 510(k) of the act, 
unless the device is intended for a use which is of substantial 
importance in preventing impairment of human health or it presents a 
potential unreasonable risk of illness or injury, hereafter referred to 
as ``reserved criteria.'' Such an exemption permits manufacturers to 
introduce into commercial distribution generic types of devices without 
first submitting a premarket notification to FDA.
    FDA has considered the endosseous dental implant accessories in 
accordance with the reserved criteria and determined that the devices 
do not require premarket notification. These devices are designed for 
use in dental implant surgery and by clinicians trained in their use. 
These devices do not have a history of risks associated with them. FDA 
further believes that manufacturers' adherence to current good 
manufacturing practices (CGMP's) in the quality system regulation will 
provide reasonable assurance of the safety and effectiveness of these 
devices.

VII. Summary of Data Upon Which the Reclassification is Based

    When endosseous implants were classified, endosseous dental implant 
accessories were considered in conjunction with the implants and were 
not independently addressed. As a result, the classification of the 
endosseous implants included the accessories. Since that time, FDA has 
reevaluated endosseous implants and endosseous dental implant 
accessories and now believes the risks associated with the implants 
listed in section V of this document under ``Risks to Health'' are not 
significantly attributable to the accessories. The risks identified 
previously relate to the skill of the clinician inserting the implant 
and the individual patient's ability to tolerate and maintain such 
implantation. Tissue degeneration, e.g., is caused by pressure from the 
implant transferring to the soft tissue and causing soft tissue 
resorption. Pain is caused by implant placement or nerve impingement. 
Bone perforation is due primarily to individual patient physiology and 
inadequate monitoring of patient selection for such procedures; the 
implant may perforate the ridge of the mandible or maxilla because the 
ridge is too thin. Infection is cause by microbial contamination of 
dental tissue compromised by degeneration or bone perforation. 
Paresthesia is caused by disturbing the neurovascular bundle during 
implant placement. Perforation of the maxillary sinus and perforation 
of the bony structures occur when the implant does not integrate. A 
fibrous pocket around an implant can cause mobility and implant loss. 
As stated previously, these risks are associated with the endosseous 
dental implant and not the accessories.
    The accessory devices that are the subject of this rule are 
intended for use by trained clinicians. Trauma to a patient's oral 
cavity from use of one of the devices is essentially controlled by the 
skills of the clinician using it. The device itself would rarely be 
responsible for the trauma. FDA believes that a minimal risk to health 
would result if these accessories were to have an

[[Page 53862]]

improper design. FDA believes that manufacturers' adherence to the 
requirements of the CGMP's would provide reasonable assurance of safety 
and effectiveness. In light of the new information, FDA believes that 
the general controls of class I would provide reasonable assurance of 
safety and effectiveness of the endosseous dental implant accessories 
for their intended use.

VIII. 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.

IX. 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 (Pub. L. 104-121)), and the Unfunded Mandates Reform Act of 1995 
(Pub. L. 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 I will relieve all manufacturers of the device of the cost of 
complying with the premarket approval requirements in section 515 of 
the act. Because reclassification will reduce regulatory costs 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 proposed rule, if issued, will not have a 
significant ecomomic impact on a substantial number of small entities. 
In addition, this proposed rule 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 of 
analysis under section 202(a) of the Unfunded Mandates Reform Act of 
1995 is not required.

X. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no 
collections of information. Therefore, clearance by the Office of 
Management and Budget under the Paperwork Reduction Act of 1995 is not 
required.

XI. Submission of Comments

    Interested persons may, on or before January 5, 1999, submit to the 
Dockets Management Branch (address above) written comments regarding 
this proposal. 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 office above between 9 
a.m. and 4 p.m., Monday through Friday.

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 in subpart D 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 872.3980 is added to subpart D to read as follows:


Sec. 872.3980  Endosseous dental implant accessories.

    (a) Identification. Endosseous dental implant accessories are 
manually powered devices intended to aid in the placement or removal of 
endosseous implants and abutments, prepare the site for placement of 
endosseous dental implants or abutments, aid in the fitting of 
endosseous dental implants or abutments, aid in the fabrication of 
dental prosthetics, and be used as an accessory with endosseous dental 
implants when tissue contact will last less than 1 hour. These devices 
include drill bits, screwdrivers, countertorque devices, placement and 
removal tools, laboratory pieces used for fabrication of dental 
prosthetics and trial abutments. These devices are made from materials 
currently in use in endosseous implant dentistry.
    (b) Classification. Class I (general controls). The device is 
exempt from premarket notification procedures in subpart E of part 807 
of this chapter subject to the limitations in Sec. 872.9.

    Dated: September 26, 1998.
D.B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 98-26816 Filed 10-6-98; 8:45 am]
BILLING CODE 4160-01-F