[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the draft guidance documents that would serve as special controls for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
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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.
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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.
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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