[Federal Register: October 10, 2000 (Volume 65, Number 196)]
[Rules and Regulations]
[Page 60098-60100]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10oc00-5]
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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: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is reclassifying the
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
dental 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 an hour. FDA is also
exempting these devices from premarket notification. This
reclassification is 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: This rule is effective November 9, 2000.
FOR FURTHER INFORMATION CONTACT: Angela 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.), 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
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 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
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'' on which any reclassification is based is required
to 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 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., 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 the endosseous dental
implant accessories in accordance with the reserved criteria and
determined that
[[Page 60099]]
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 October 7, 1998 (63 FR 53859), FDA
proposed to reclassify the 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 dental 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. Interested persons were given until January 5, 1999, to comment
on the proposed regulation. FDA received no comments on the proposed
rule.
III. Summary of Final Rule
FDA is reclassifying the 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 dental 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 do not have a history of risks associated with
them. FDA believes that the manufacturers' adherence to current good
manufacturing practices in the quality system regulation will provide
reasonable assurance of the safety and effectiveness of these devices.
FDA, therefore, believes that class I would provide reasonable
assurance of safety and effectiveness. FDA is also exempting the
devices from the premarket notification requirements.
Therefore, under section 513 of the act, FDA is adopting the
assessment of the risks to public health stated in the proposed rule
published on October 7, 1998. Furthermore, FDA is issuing a final rule
that revises part 872 (21 CFR part 872) in subpart D to add
Sec. 872.3980, thereby reclassifying the endosseous dental implant
accessories, from class III into class I.
IV. 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.
V. 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 (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 final rule is consistent
with the regulatory philosophy and principles identified in the
Executive Order. In addition, the final 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. Because the final rule reclassifying these devices
from class III to class I will relieve all manufacturers of the devices
of the cost of complying with the premarket approval requirements in
section 513 of the act, 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 the final rule will not have a significant economic
impact on a substantial number of small entities. In addition, this
final 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.
VI. Paperwork Reduction Act of 1995
This final 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.
VII. Federalism
FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies that have 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, the agency has concluded
that the rule does not contain policies that have federalism
implications as defined in the order and, consequently, a federalism
summary impact statement is not required.
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, 21 CFR
part 872 in subpart D is 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 dental 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.
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 872.9.
[[Page 60100]]
Dated: September 26, 2000.
Linda S. Kahan, Deputy Director for Regulations Policy center for
Devices and Radiological Health.
[FR Doc. 00-25811 Filed 10-6-00; 8:45 am]
BILLING CODE 4160-01-F