[Federal Register: August 23, 2004 (Volume 69, Number 162)]
[Rules and Regulations]               
[Page 51765-51766]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23au04-3]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 872

[Docket No. 2003N-0390]

 
Dental Devices; Dental Noble Metal Alloys and Dental Base Metal 
Alloys; Designation of Special Controls

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY:  The Food and Drug Administration is amending the 
identification and classification regulations of gold-based alloys and 
precious metal alloys for clinical use and base alloys devices in order 
to designate a special control for these devices. FDA is also exempting 
these devices from premarket notification requirements. The agency is 
taking this action on its own initiative. This action is being taken 
under the Federal Food, Drug, and Cosmetic Act (the act), as amended by 
the Safe Medical Devices Act of 1990 (SMDA), and the Food and Drug 
Administration Modernization Act of 1997 (FDAMA). Elsewhere in this 
issue of the Federal Register, FDA is announcing the availability of 
the draft guidance documents that would serve as special controls for 
these devices.

DATES: This rule is effective September 22, 2004.

FOR FURTHER INFORMATION CONTACT: Michael E. Adjodha, Center for Devices 
and Radiological Health (HFZ-480), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-827-5283, ext.123, e-mail: 
mea@cdrh.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    The act (21 U.S.C. 301 et seq.), as amended by the Medical Devices 
Amendments of 1976 (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 as follows: Class I 
(general controls), Class II (special controls), and Class III 
(premarket approval).
    Under section 513 of the act, FDA refers to devices that were in 
commercial distribution before May 28, 1976 (the date of enactment of 
the 1976 amendments), as preamendments devices. Under the 1976 
amendments, class II devices are identified as those devices in which 
general controls by themselves are insufficient to provide reasonable 
assurance of safety and effectiveness of the device, but for which 
there is sufficient information to establish a performance standard to 
provide such assurance.
    The SMDA broadened the definition of class II devices to include 
those devices for which general controls would not provide reasonable 
assurance of the safety and effectiveness, but for which there is 
sufficient information to establish special controls to provide such 
assurance. The special controls include performance standards, 
postmarket surveillance, patient registries, development and 
dissemination of guidelines, recommendations, and any other appropriate 
actions the agency deems necessary to provide such assurance. See 
section 513(a)(1)(B) of the act.
    FDAMA added, among other sections, a new section 510(m) to the act 
(21 U.S.C. 360(m)). Under new section 510(m) of the act, FDA may exempt 
a class II device from premarket notification requirements (510(k)) (21 
U.S.C. 360(k)), if the agency determines that premarket notification is 
not necessary to assure the safety and effectiveness of the device.
    In the Federal Register of December 1, 2003 (68 FR 67097), FDA 
issued a proposed rule to amend the classification regulation of gold-
based alloys and precious metal alloys for clinical use and base metal 
alloy devices. FDA identified the draft guidance documents 
entitled:``Class II Special Controls Guidance Document: Dental Precious 
Metal Alloys'' and ``Class II Special Controls Document: Dental Base 
Metal Alloys'' as the proposed special controls capable of providing 
reasonable assurance of the safety and effectiveness of these devices. 
FDA invited interested persons to comment on the proposed rule and the 
draft guidance documents by March 1, 2004. FDA received three comments.

II. Summary of Comments and FDA Response

    FDA received one comment from a consumer and one (in duplicate) 
from a trade association. Both comments were in support of the proposed 
reclassification with minor modifications suggested. The subject of the 
consumer comment was that the name of the regulation ``gold based 
alloys and precious metal alloys for clinical use'' is unscientific 
since gold is, by definition, a precious metal.
    FDA agrees that the name of the regulation is redundant and, 
accordingly, has changed the final rule to modify Sec.  872.3060 to 
read ``noble metal,'' as the term encompasses all precious metals such 
as gold. The description ``for clinical use'' has been deleted because 
it is clear from the identification that such use is intended. For 
precision and clarity, we have also modified the identifications in 
Sec. Sec.  872.3060 and 872.3710 to more precisely describe these 
alloys and their component metals.
    The subject of the trade association comment was that: (1) The 
scope of the dental base metal alloys guidance is not clear as to what 
alloys are subject to the guidance and (2) the recommendation that the 
labeling for nickel-containing alloys contain a contraindication for 
hypersensitive individuals is unnecessary because nickel has been 
demonstrated to be biocompatible.
    FDA agrees that more clarity is needed and has modified the scope 
of the guidance to define the devices not clearly addressed by the 
guidance. Regarding the second point, while FDA agrees that nickel has 
been demonstrated to be biocompatible for this intended use, FDA 
disagrees that the labeling should not contain a contraindication for 
nickel hypersensitive individuals. The agency believes this warning is 
needed to minimize the potential for adverse events associated with 
improper use of this device. Nickel, although biocompatible, is a known 
sensitizing agent for a small percentage of the population. FDA 
believes that removing this warning will increase the risk of the 
device by potentially exposing nickel-hypersensitive individuals who, 
otherwise, would not be exposed because of the current warning labels.

[[Page 51766]]

III. FDA's Conclusion

    Based on the findings outlined in the preamble, FDA concludes that 
special controls, in conjunction with general controls, provide 
reasonable assurance of the safety and effectiveness of these devices. 
FDA is designating the guidance documents entitled: ``Class II Special 
Controls Guidance Document: Dental Noble Metal Alloys'' and ``Class II 
Special Controls Guidance Document: Dental Base Metal Alloys'' as the 
special controls that the agency believes will reasonably assure the 
safety and effectiveness for noble metal alloys and base metal alloys, 
respectively.
    Following the effective date of the final rule exempting the 
device, manufacturers of these devices will need to address the issues 
covered in this special control guidance. However, the manufacturer 
need only show that its device meets the recommendations of the 
guidance or in some other way provides equivalent assurances of safety 
and effectiveness. If manufacturers cannot comply with these 
recommendations or equivalent measures, they will not be exempt from 
the requirements of premarket notification and will need to submit a 
premarket notification and receive clearance for their device prior to 
marketing.

IV. Electronic Access

    Persons with access to the Internet may access the Center for 
Devices and Radiological Health web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http:///www.fda.gov/cdrh A search capability for all CDRH documents is available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/guidances.html.
 Guidance documents are available on 

the Division of Dockets Management Internet site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets
.


V. 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 environmental. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

VI. 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), 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 not a significant regulatory action 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. The purpose of this final rule is to designate a 
special control for these devices. FDA has designated guidance 
documents as the special controls. Because manufacturers, including 
small manufacturers, are already substantially in compliance with the 
recommendations in the guidance documents, and they will not add 
substantially to the information manufacturers presently submit, the 
agency certifies that the final rule will not have a significant 
economic impact on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $110,000,000 million. FDA does not expect this final 
rule to result in any 1-year expenditure that would meet or exceed this 
amount.

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, 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 executive order and, consequently, a 
federalism summary impact statement is not required.

VIII. 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 (44 U.S.C. 3501-3520) is not required.

List of Subjects in 21 CFR Part 872

    Medical devices.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
872 is amended as follows:

PART 872--DENTAL DEVICES

0
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.

0
2. Section 872.3060 and the section heading are revised to read as 
follows:


Sec.  872.3060  Noble metal alloy.

    (a) Identification. A noble metal alloy is a device composed 
primarily of noble metals, such as gold, palladium, platinum, or 
silver, that is intended for use in the fabrication of cast or 
porcelain-fused-to-metal crown and bridge restorations.
    (b) Classification. Class II (special controls). The special 
control for these devices is FDA's ``Class II Special Controls Guidance 
Document: Dental Noble Metal Alloys.'' The devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec.  872.9. See Sec.  872.1(e) 
for availability of guidance information.

0
3. Section 872.3710 is revised to read as follows:


Sec.  872.3710  Base metal alloy.

    (a) Identification. A base metal alloy is a device composed 
primarily of base metals, such as nickel, chromium, or cobalt, that is 
intended for use in fabrication of cast or porcelain-fused-to-metal 
crown and bridge restorations.
    (b) Classification. Class II (special controls). The special 
control for this device is FDA's ``Class II Special Controls Guidance 
Document: Dental Base Metal Alloys.'' 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. See Sec.  872.1(e) 
for availability of guidance information.

    Dated: August 11, 2004.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 04-19178 Filed 8-20-04; 8:45 am]

BILLING CODE 4160-01-S