[Federal Register: August 23, 2004 (Volume 69, Number 162)]
[Notices]
[Page 51854-51855]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23au04-55]
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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availability of the draft guidance documents entitled ``Class II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 These draft guidance documents describe means by which noble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diskette of the draft guidance documents entitled ``Class II Special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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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:
mea@cdrh.fda.gov.
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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. 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://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 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: 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