[Federal Register: December 1, 2003 (Volume 68, Number 230)]
[Notices]               
[Page 67196-67197]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01de03-88]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0391]

 
Draft Guidance for Industry and FDA Staff; Class II Special 
Controls Guidance Document: Dental Precious 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availability of the draft guidance documents entitled ``Class II 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 Precious Metal Alloys'' and 
``Class II Special Controls Guidance Document: Dental Base Metal 
Alloys.'' These guidance documents describe means by which gold-based 
alloys and precious metal alloys for clinical use 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 proposed rule to amend the classification regulations of 
gold-based alloys and precious metal alloys for clinical use and base 
metal alloy devices presently classified in class II. In the proposed 
rule, FDA is also proposing to exempt these devices from premarket 
notification.

DATES:  Submit written or electronic comments on these draft guidances 
by March 1, 2004, to ensure their adequate consideration in preparation 
of the final guidances. General comments on agency guidance documents 
are welcome 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diskette of the draft guidance documents entitled ``Class II Special 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 Precious 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 
two self-addressed adhesive labels 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 guidance.
    Submit written comments on 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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, mea@cdrh.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of the draft guidance documents 
entitled ``Class II Special Controls Guidance Document: Dental Precious 
Metal Alloys'' and ``Class II Special Controls Guidance Document: 
Dental Base Metal Alloys.'' These guidance documents describe means by 
which gold-based alloys and precious metal alloys for clinical use and 
base metal alloy devices may comply with the requirement of class II 
special controls. Conformance with these guidance documents as special 
controls means that manufacturers will be able to introduce their 
device for commercial distribution in the United States without 
premarket notification and clearance. If these guidance documents are 
made final, they will supersede ``Guidance Document for the Preparation 
of Premarket Notifications [510(k)'s] for Dental Alloys'' issued on 
March 3, 1997.
    Elsewhere in this issue of the Federal Register, FDA is publishing 
a proposed rule to amend the classification regulations of gold-based 
alloys and precious metal alloys for clinical use and base metal alloy 
devices presently classified in class II. If the proposed rule becomes 
final, manufacturers of gold-based alloys and precious metal alloys for 
clinical use and base metal alloy devices will need to address the 
issues covered in these special controls guidances in order to be 
exempt from the 510(k) requirements of the Federal Food, Drug, and 
Cosmetic Act. However, the manufacturer need only show that its device 
meets the recommendations of the guidances or in some way provides 
equivalent assurances of safety and effectiveness. These draft guidance 
documents are not final nor are they in effect at this time.

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 gold-based alloys and 
precious metal alloys for clinical use and base 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 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 on these draft 
guidances. Submit a single copy of electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/


[[Page 67197]]

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 
Precious 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 (1415) followed by the pound sign 
([numsign]). Follow the remaining voice prompts to complete your 
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 
([numsign]). 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://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 guidance documents is available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/guidance.html. 

Guidance documents are also 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.

    Dated: October 2, 2003.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 03-29740 Filed 11-28-03; 8:45 am]

BILLING CODE 4160-01-S