[Federal Register Volume 65, Number 196 (Tuesday, October 10, 2000)]
[Rules and Regulations]
[Pages 60098-60100]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-25811]


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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.


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    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