[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Draft Guidance for Industry and FDA Staff; Class II Special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availability of the draft guidance documents entitled ``Class II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diskette of the draft guidance documents entitled ``Class II Special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