[Federal Register: May 12, 2004 (Volume 69, Number 92)]
[Notices]
[Page 26398-26399]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12my04-56]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2002D-0113]
Guidance for Industry and Food and Drug Administration Staff;
Class II Special Controls Guidance Document: Root-Form Endosseous
Dental Implants and Endosseous Dental Implant Abutments; 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 guidance entitled ``Class II Special Controls
Guidance Document: Root-Form Endosseous Dental Implants and Endosseous
Dental Implant Abutments.'' This guidance document describes a means by
which root-form endosseous dental implants and endosseous dental
implant abutments 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 reclassify these devices from class
III to class II (special controls).
DATES: Submit written or electronic comments on agency guidances at any
time.
ADDRESSES: Submit written requests for single copies on a 3.5''
diskette of the guidance document entitled ``Class II Special Controls
Guidance Document: Root-form Endosseous Dental Implants and Endosseous
Dental Implant Abutments'' 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 guidance.
Submit written comments concerning this guidance 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. Identify comments with the
docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Angela Blackwell, Center for Devices
and Radiological Health (HFZ-480), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-827-5283.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of May 14, 2002 (67 FR 34458), FDA
announced the availability of a draft of this guidance document and
invited interested persons to comment on it by August 12, 2002. FDA
received a total of five comments on the proposed guidance and
reclassification rule. Four comments sought clarification in the
guidance document about the following issues: (1) Table of risks to
health and mitigation measures and (2) fatigue testing. FDA revised the
table extensively to communicate the risks more clearly and to improve
the correlation between risks and mitigations without deleting any
risks or mitigations. Although FDA disagreed with the comments about
fatigue testing, as stated in the guidance document, the agency will
consider other ways that show equivalent assurances of safety and
effectiveness. In response to comments, FDA also modified other areas
of the guidance document for clarity.
The guidance document provides a means by which root-form
endosseous dental implants and endosseous dental implant abutments may
comply with the requirement of special controls for class II devices.
Following the effective date of the final reclassification rule, any
firm submitting a 510(k) for the devices will need to address the
issues covered in the special control 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.
Also in the Federal Register of May 14, 2002 (67 FR 34416), FDA
proposed to reclassify root-form endosseous dental implants and
endosseous dental implant abutments into class II with this guidance
document as the special control. Elsewhere in this issue of the Federal
Register, FDA is publishing a final rule to reclassify root-form
endosseous dental implants and endosseous dental implant abutments from
class III (premarket approval) to class II (special controls).
II. Significance of Guidance
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
agency's current thinking on root-form endosseous dental implants and
endosseous dental implant abutments. It does not create or confer any
rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if the approach satisfies
the requirements of the applicable statute and regulations.
III. Electronic Access
To receive ``Class II Special Controls Guidance Document: Root-form
Endosseous Dental Implants and Endosseous Dental Implant Abutments'' by
fax machine, call the Center for Devices and Radiological Health (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 (1389)
followed by the pound sign (). Follow the remaining voice
prompts to complete your request.
Persons interested in obtaining a copy of the guidance also may do
so by using the Internet. CDRH maintains an entry 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 guidance documents is available at http://www.fda.gov/cdrh/guidance.html.
Guidance documents are also available on the Division of Dockets
Management Internet site at http://www.fda.gov/ohrms/dockets.
IV. Paperwork Reduction Act of 1995
This guidance contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (the PRA) (44 USC 3501-3520). The
collections of information addressed in the guidance document 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 guidance have been approved by OMB under the PRA under OMB control
number 0910-0485.
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V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), written or electronic comments regarding this document
at any time. Submit a single copy of electronic comments to http://www.fda.gov/dockets/ecomments.
Submit two paper copies of any mailed
comments, except that individuals may submit one copy. Comments are to
be identified with the docket number found in brackets in the heading
of this document. Comments received may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: May 3, 2004.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 04-10749 Filed 5-11-04; 8:45 am]
BILLING CODE 4160-01-S