[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