[Federal Register Volume 69, Number 162 (Monday, August 23, 2004)]
[Notices]
[Pages 51854-51855]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-19179]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0391]


Draft Guidances for Industry and Food and Drug Administration 
Staff; Class II Special Controls Guidance Document: Dental Noble Metal 
Alloys and Class II Special Controls Guidance Document: Dental Base 
Metal Alloys; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance documents entitled ``Class II 
Special Controls Guidance Document: Dental Noble Metal Alloys'' and 
``Class II Special Controls Guidance Document: Dental Base Metal 
Alloys.'' These draft guidance documents describe means by which noble 
metal alloy and base metal alloy devices may comply with the 
requirement of special controls for class II devices. Elsewhere in this 
issue of the Federal Register, FDA is publishing a final rule to amend 
the identification and classification regulations of gold-based alloys 
and precious metal alloys for clinical use and base metal alloy devices 
presently classified in class II. FDA is also exempting these devices 
from premarket notification requirements.

DATES: Submit written or electronic comments on the draft guidances at 
any time.

ADDRESSES: Submit written requests for single copies on a 3.5'' 
diskette of the draft guidance documents entitled ``Class II Special 
Controls Guidance Document: Dental Noble Metal Alloys'' and ``Class II 
Special Controls Guidance Document: Dental Base Metal Alloys'' to the 
Division of Small Manufacturers, International, and Consumer Assistance 
(HFZ-220), Center for Devices and Radiological Health, Food and Drug 
Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-
addressed adhesive label to assist that office in processing your 
request, or fax your request to 301-443-8818. See the SUPPLEMENTARY 
INFORMATION section for information on electronic access to the 
guidances.
    Submit written comments concerning these draft guidances 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.

[[Page 51855]]


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: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA issued a final rule classifying gold-based alloys and precious 
metal alloys for clinical use and base metal alloy devices in the 
Federal Register of August 12, 1987 (52 FR 30082). These devices were 
classified before the provisions of the Safe Medical Devices Act of 
1990 (SMDA) broadened the definition of class II devices to establish 
special controls beyond performance standards. FDA published a proposed 
rule in the Federal Register of December 1, 2003 (68 FR 67097) to amend 
the classification regulation of these class II devices. FDA received 
three comments.
    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 consumer 
comment states that the name of the regulation ``gold based alloys and 
precious metal alloys for clinical use'' is unscientific because gold 
is, by definition, a precious metal. FDA agrees with this comment and 
has amended Sec.  872.3060 (21 CFR 827.3060) to read ``noble metal 
alloy'' and deleted ``for clinical use.''
    The subject of the trade association comment was that the scope of 
the dental base metal alloys guidance is not clear as to what alloys 
are subject to the guidance. FDA agrees with this comment and has 
modified the scope of the guidance to define the devices not clearly 
addressed by the guidance.
    The trade association comment also recommended that FDA's 
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 disagrees that 
the labeling should not contain a contraindication for nickel 
hypersensitive individuals. FDA believes that this warning is needed to 
minimize the potential for adverse events associated with improper use 
of this device.
    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.

II. Significance of Guidance

    These draft guidances are being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidances 
represent the agency's current thinking on base metal alloy and noble 
metal alloy devices. They do not create or confer any rights for or on 
any person and do not operate to bind FDA or the public. An alternative 
approach may be used if such an approach satisfies the requirements of 
the applicable statute and regulations.

III. Paperwork Reduction Act of 1995

    These guidances contain information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) (the PRA). 
The collections of information addressed in the guidance documents have 
been approved by OMB in accordance with the PRA under the regulations 
governing premarket notification submissions (21 CFR part 807, subpart 
E, OMB control number 0910-0120). The labeling provisions addressed in 
the guidances have been approved by OMB under the PRA under OMB control 
number 0910-0485.

IV. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES), written or electronic comments regarding this 
document. Submit a single copy of electronic comments 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. Copies of the draft guidance documents and 
received comments may be seen in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.

V. Electronic Access

    To receive ``Class II Special Controls Guidance Document: Dental 
Noble Metal Alloys'' by fax, call the CDRH Facts-On-Demand system at 
800-899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to 
enter the system. At the voice prompt, press 1 to order a document. 
Enter the document number 1415 followed by the pound sign (). 
Follow the remaining voice prompts to complete you request. To receive 
``Class II Special Controls Guidance Document: Dental Base Metal 
Alloys'' by fax, call the CDRH Facts-On-Demand system at 800-899-0381 
or 301-827-0111 from a touch-tone telephone. Press 1 to enter the 
system. At the second voice prompt, press 1 to order a document. Enter 
the document number 1416 followed by the pound sign (). Follow 
the remaining voice prompts to complete your request. Persons 
interested in obtaining a copy of these draft guidances may also do so 
using the Internet. CDRH maintains a site on the Internet for easy 
access to information including text, graphics, and files that may be 
downloaded to a personal computer with Internet access. Updated on a 
regular basis, the CDRH home page includes device safety alerts, 
Federal Register reprints, information on premarket submissions 
(including lists of approved applications and manufacturers' 
addresses), small manufacturer's assistance, information on video 
conferencing and electronic submissions, Mammography Matters, and other 
device-oriented information. The CDRH web site may be accessed at 
http://www.fda.gov/cdrh. A search capability for all CDRH documents is 
available at http://www.fda.gov/cdrh/guidances.html. Guidance documents 
are also available on the Division of Dockets Management Internet site 
at http://www.fda.gov/ohrms/dockets.

    Dated: August 11, 2004.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 04-19179 Filed 8-20-04; 8:45 am]
BILLING CODE 4160-01-S