[Federal Register Volume 67, Number 157 (Wednesday, August 14, 2002)]
[Notices]
[Pages 53005-53006]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-20500]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0306]


Medical Devices; Class II Special Controls Guidance Document: 
Dental Sonography and Jaw Tracking Devices; Draft Guidance for Industry 
and FDA Reviewers; 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availability of the draft guidance entitled ``Class II Special Controls 
Guidance Document: Dental Sonography and Jaw Tracking Devices; Draft 
Guidance for Industry and FDA Reviewers.'' This draft guidance document 
was developed as a special control guidance to support the 
classification of certain dental sonography and jaw tracking devices 
into class II. Elsewhere in this issue of the Federal Register, FDA is 
publishing a proposed rule to classify 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DATES: Submit written or electronic comments on the draft guidance by 
November 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diskette of the draft guidance document entitled ``Class II Special 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: Dental Sonography and Jaw Tracking Devices; 
Draft Guidance for Industry and FDA Reviewers'' to the Division of 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    Submit written comments concerning this draft guidance to the 
Dockets Management Branch (HFA-305), 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. Comments should be identified with the docket number 
found in brackets in the heading of this document. See the 
SUPPLEMENTARY INFORMATION section for information on electronic access 
to the guidance.

FOR FURTHER INFORMATION CONTACT: Mary S. Runner, 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

    FDA developed this draft guidance document as a special control 
guidance to support the classification of certain dental sonography and 
jaw tracking devices into class II. FDA believes that special controls, 
when combined with the general controls, will be sufficient to provide 
reasonable assurance of the safety and effectiveness of dental 
sonography and jaw tracking devices. This draft guidance document 
identifies the class, product code, and classification definition for 
these devices. In addition, it identifies the risks to health generally 
associated with this generic type of device, describes the device 
evaluation and labeling measures that FDA believes will mitigate those 
risks, explains how manufacturers should address those risks in a 
premarket notification submission, and serves as a special control 
that, when combined with the general controls, will address the risks 
associated with this generic device type.

II. Significance of Guidance

    This draft guidance document represents the agency's current 
thinking on certain dental sonography and jaw tracking 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 statute 
and regulations.
    The agency has adopted good guidance practices (GGPs), and 
published the final rule, which set forth the agency's regulations for 
the development, issuance, and use of guidance documents (21 CFR 
10.115). This guidance document is issued as a level 1 draft guidance 
in accordance with the GGP regulations.

III. Electronic Access

    In order to receive the draft guidance entitled ``Class II Special 
Controls Guidance Document: Dental Sonography and Jaw Tracking Devices; 
Draft Guidance for Industry and FDA Reviewers'' 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 
(1393) 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. The Center for Devices and Radiological 
Health (CDRH) maintains an entry on the Internet for easy access to 
information including text, graphics, and files that you may download 
to a personal computer. 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 manufacturers' assistance, information 
on video conferencing and electronic submissions, Mammography Matters, 
and other device-oriented information. You may access the CDRH home 
page at http://www.fda.gov/cdrh. You may search for all CDRH guidance 
documents at http://www.fda.gov/cdrh/guidance.html. Guidance documents 
are also available 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 (44 U.S.C. 3501-3520). The burden 
hours associated with 21 CFR part 807, subpart E were approved under 
OMB control number 0910-0120.

V. Comments

    You may submit to the Dockets Management Branch (see ADDRESSES) 
written comments regarding this draft guidance by November 12, 2002. 
You should submit two copies of any comments. Individuals may submit 
one copy. You must identify comments with the docket number found in 
brackets in the heading of this document. You may see the guidance 
document and any

[[Page 53006]]

comments FDA receives in the Dockets Management Branch between 9 a.m. 
and 4 p.m., Monday through Friday.

    Dated: August 1, 2002.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-20500 Filed 8-13-02; 8:45 am]
BILLING CODE 4160-01-S