[Federal Register Volume 67, Number 93 (Tuesday, May 14, 2002)]
[Notices]
[Pages 34458-34459]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-12042]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0113]


Medical Devices; Draft Guidance for Industry and FDA on Class II 
Special Controls: Root-Form Endosseous Dental Implants and 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availability of the draft guidance entitled ``Class II Special Controls 
Guidance Document: Root-form Endosseous Dental Implants and Abutments; 
Draft Guidance for Industry and FDA.'' This draft guidance document was 
developed as a special control guidance to support the reclassification 
of the root-form endosseous dental implant device from class III to 
class II and the reclassification of the endosseous dental implant 
abutment device from class III to class II. Elsewhere in this issue of 
the Federal Register, FDA is issuing a proposed rule to reclassify 
these device types. This guidance is neither final nor is it in effect 
at this time.

DATES:  Submit written or electronic comments on the draft guidance by 
August 12, 2002.

ADDRESSES:  Submit written requests for single copies on a 3.5'' 
diskette of the draft guidance document entitled ``Class II Special 
Controls Guidance Document: Root-form Endosseous Dental Implants and 
Abutments; Draft Guidance for Industry and FDA'' to the Division of 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. Submit written comments 
on the draft guidance to the Dockets Management Branch (HFA-305), Food 
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 
20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Angela E. Blackwell, Center for 
Devices and Radiological Health (HFZ-480), Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-
8879.

SUPPLEMENTARY INFORMATION:

I. Background

    This draft guidance document describes a means by which the root-
form endosseous dental implant device and the endosseous dental implant 
abutment device may comply with the requirement of special controls for 
class II devices. A root-form endosseous dental implant device is 
intended to be surgically placed in the bone of the upper or lower 
arches to provide support for prosthetic devices, such as artificial 
teeth, in order to restore the patient's chewing function. An 
endosseous dental implant abutment device is a separate component that 
is attached to the implant and is intended to aid in prosthetic 
rehabilitation.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on root-form 
endosseous dental implant and endosseous dental implant abutment 
devices. 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 such approach satisfies the requirements of the 
applicable statutes and regulations.

III. Electronic Access

    In order to receive the draft guidance entitled ``Class II Special 
Controls Guidance Document: Root-form Endosseous Dental Implants and 
Abutments; Draft Guidance for Industry and FDA'' via your fax machine, 
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 
(1389) followed by the pound sign (). Follow the remaining 
voice prompts to complete your request.
    Persons interested in obtaining a copy of the draft guidance may 
also do so 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 the civil money penalty 
guidance documents package, device safety alerts, Federal Register 
reprints, information on premarket submissions (including lists of 
approved applications and manufacturers' addresses), small 
manufacturers'

[[Page 34459]]

assistance, information on video conferencing and electronic 
submissions, Mammography Matters, and other device-oriented 
information. The CDRH home page may be accessed at http://www.fda.gov/cdrh. Guidance documents are also available at http://www.fda.gov/ohrms/dockets/default.htm.

IV. Comments

    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written or electronic comments on the draft guidance by 
August 12, 2002. Two copies of any comments are to be submitted, 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. The draft guidance and received comments are available for 
public examination in the Dockets Management Branch between 9 a.m. and 
4 p.m., Monday through Friday.

    Dated: April 23, 2002.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-12042 Filed 5-13-02; 8:45 am]
BILLING CODE 4160-01-S