[Federal Register Volume 69, Number 92 (Wednesday, May 12, 2004)]
[Notices]
[Pages 26398-26399]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-10749]



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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