[Federal Register Volume 68, Number 230 (Monday, December 1, 2003)]
[Proposed Rules]
[Pages 67097-67100]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-29739]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 872

[Docket No. 2003N-0390]


Dental Devices; Gold Based Alloys, Precious Metal Alloys, and 
Base Metal Alloys; Designation of Special Controls

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
the classification regulations of gold-based alloys and precious metal 
alloys for clinical use and base metal alloy devices. FDA is also 
proposing to exempt these devices from premarket notification and 
designate a special control for these devices. 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 
guidance documents that would serve as special controls for these 
devices.

[[Page 67098]]


DATES: Submit written or electronic comments by March 1, 2004. See 
section X of this document for the proposed effective date of a final 
rule based on this document.

ADDRESSES: Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov.dockets/ecomments.

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, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background (Regulatory Authorities)

    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:
    [sbull] Class I (general controls),
    [sbull] Class II (special controls), and
    [sbull] 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.

II. Regulatory History of the Devices

    In the Federal Register of August 12, 1987 (52 FR 30082), FDA 
issued a final rule classifying 42 dental devices into class II, 
including gold-based alloys and precious metal alloys for clinical use 
and base metal alloy under the 1976 amendments.

III. Proposed Rule

    FDA is proposing to amend the classification regulation of gold-
based alloys and precious metal alloys for clinical use and base metal 
alloy devices in order to designate a special control for these 
devices. These devices were classified before the provisions of the 
SMDA broadened the definition of class II devices to establish special 
controls beyond performance standards and before the SMDA regulations 
became effective. Therefore, designating device-specific guidance as a 
means to provide reasonable assurance of the safe and effectiveness of 
the device was not a regulatory option at the time. Since the 
classification, FDA has not developed a performance standard for these 
devices.
    FDA has now developed guidance documents for these devices and, 
under the SMDA provisions, is proposing to designate the special 
controls the agency believes will reasonably assure the safety and 
effectiveness of these devices. FDA is identifying the guidance 
documents entitled ``Class II Special Controls Guidance Document: 
Dental Precious Metal Alloys'' and ``Class II Special Controls Guidance 
Document: Dental Base Metal Alloys'' as the proposed special control 
for precious metal alloys (including gold based) and base metal alloys, 
respectively. Following the effective date of any final classification 
rule based on this proposed rule, any firm claiming exemption from the 
premarket notification requirements for a dental precious metal or base 
metal alloy covered by the rule will need to address the issues covered 
in the appropriate special controls guidance. However, the firm need 
only show that its device meets the recommendations of the guidance or 
in some other way provides equivalent assurances of safety and 
effectiveness.
    Under section 510(m)(1) of the act, FDA is also proposing to exempt 
these devices from premarket notification. The agency has determined 
that a 510(k) is not necessary to assure the safety and effectiveness 
of these devices.

IV. Risks to Health

    FDA has identified the following risks to health associated with 
these devices: Device failure, adverse tissue reaction, and improper 
use.

A. Device Failure

    The mechanical properties of precious and base metal casting 
alloys, and solders and porcelain-fused-to-metal (PFM) alloys may be 
insufficient to support the required loads and lead to device failure. 
Some alloy compositions used in base metal casting alloys and solders, 
may be susceptible to corrosion, which can lead to device failure. 
Porcelain in PFM alloys may deform, crack, and debond from the metal 
because of incompatibilities leading to device failure. Device failure 
will result in ineffective treatment, revision, and possibly minor, 
temporary impairment for the patient.

B. Adverse Tissue Reaction

    Some alloy compositions, especially those containing nickel, as 
pertaining to base metal casting alloys and solders, may not be 
biocompatible. Poor biocompatibility may result in adverse tissue 
reaction.

C. Improper Use

    Inadequate labeling may result in improper use. Improper use may 
result in ineffective treatment and may cause minor temporary 
impairment for the patient.

V. Special Controls

    FDA believes that, in addition to general controls, the class II 
special controls guidance documents entitled ``Class II Special 
Controls Guidance: Dental Precious Metal Alloys'' and ``Class II 
Special Controls Guidance Document: Dental Base Metal Alloys'' are 
adequate controls to address the risks to health described in section 
IV of this document. The class II special controls guidance documents 
provide information on how to control the risks to health of device 
failure, adverse tissue reaction, and improper use, by identifying FDA-
recognized consensus standards and labeling that wil mitigate risks to 
health included in the guidances.
    The consensus standards provide minimum mechanical properties to

[[Page 67099]]

address the risks of device failure. Adherence to the recommended 
standards can mitigate the risk of device failure, e.g., PFM deforming, 
cracking, or debonding because of biocompatibility.
    Another consensus standard identified in the special controls 
guidance recommends biocompatibility testing. Adherence to this 
standard can mitigate the risk of adverse tissue reaction by ensuring 
that the device materials are sufficiently biocompatible for use as 
permanent implants.
    The labeling information provided in the guidance documents 
addresses the risk of improper use by recommending that manufacturers, 
in addition to complying with the general labeling provisions of 21 CFR 
part 801, include indications for use and contraindications for 
individuals with nickel hypersensitivity in their labeling.
    FDA believes that premarket notification is not necessary to 
provide reasonable assurance of the safety and effectiveness of these 
devices and, therefore, is giving notice of its intent to exempt the 
devices from that requirement if the recommendations of the special 
controls guidance are met.
    Elsewhere in this issue of the Federal Register, FDA is publishing 
a notice of availability of the draft guidance documents that would 
serve as the special controls for these devices.

VI. 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.

VII. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the 
Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1501 et seq.). 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. The purpose of this proposed rule is to designate a 
special control for these devices. FDA has designated guidance 
documents as the special controls. FDA believes that 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. 
FDA, therefore, believes that the rule will impose no significant 
economic impact on any small entities. The agency, therefore, certifies 
that this proposed rule will not have a significant economic 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 or analysis under section 202(a) of the 
Unfunded Mandates Reform Act of 1995 is not required.

VIII. Paperwork Reduction Act of 1995

    This proposed 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.

IX. Submission of Comments

    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written or electronic comments regarding this proposed rule. 
Submit a single copy of electronic comments to http://www.fda.gov/dockets/ecomments or two paper copies of any written comments, except 
that individuals may submit one paper 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 Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

X. Proposed Implementation Plan

    FDA proposes that any final regulation that may issue based on this 
proposal become effective 30 days after its date of publication in the 
Federal Register. Following the effective date of a final rule 
exempting the device, manufacturers of dental precious metal alloy and 
base metal alloy devices will need to address the issues covered in 
these special controls guidances. 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.

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 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 872.1 is amended by revising paragraph (e) to read as 
follows:


Sec.  872.1  Scope.

* * * * *
    (e) Guidance documents in this part may be obtained on the Internet 
at http://www.fda.gov/cdrh/guidance.html.
    3. Section 872.3060 is amended by revising paragraph (b) to read as 
follows:


Sec.  872.3060  Gold-based alloys and precious metal alloys for 
clinical use.

* * * * *
    (b) Classification. Class II (special controls). The special 
control for these devices is FDA's ``Class II Special Controls Guidance 
Document: Dental Precious 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.)
    4. Section 872.3710 is amended by revising paragraph (b) to read as 
follows:


Sec.  872.3710  Base metal alloy.

* * * * *
    (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.)


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    Dated: October 2, 2003.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 03-29739 Filed 11-28-03; 8:45 am]
BILLING CODE 4160-01-S