[Federal Register: December 2, 2003 (Volume 68, Number 231)]
[Notices]               
[Page 67458-67459]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02de03-76]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2002D-0306]

 
Guidance for Industry and FDA Staff; Class II Special Controls 
Guidance Document: Dental Sonography and Jaw Tracking Devices; 
Availability

AGENCY: Food and Drug Administration, HHS.

[[Page 67459]]


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: Dental Sonography and Jaw Tracking Devices.'' This 
guidance document describes a means by which certain dental sonography 
and jaw tracking 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 classify certain types of 
these devices into class II (special controls).

DATES: Submit written or electronic comments on this guidance at any 
time. General comments on agency guidance documents are welcome 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: Dental Sonography and Jaw Tracking Devices'' 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. 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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: Mary S. Runner, Center for Devices and 
Radiological Health (HFZ-480), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850301-827-5283.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of August 14, 2002 (67 FR 52901), FDA 
published a proposed rule to classify certain dental sonography and jaw 
tracking devices into class II. In the Federal Register of August 14, 
2002 (67 FR 53005), FDA also identified the document ``Class II Special 
Controls Guidance Document: Dental Sonography and Jaw Tracking Devices; 
Draft Guidance for Industry and FDA Reviewers'' as the special control, 
which in conjunction with general controls, is capable of providing 
reasonable assurance of safety and effectiveness for these devices. 
This guidance document describes a means by which certain dental 
sonography and jaw tracking devices may comply with the requirement of 
special controls for class II devices.
    Following the effective date of the final classification rule, any 
firm submitting a 510(k) premarket notification for the class II 
devices described in that final rule 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.
    Interested persons were invited to comment on the draft guidance by 
November 12, 2002. FDA received no comments on the draft guidance 
document. FDA made minor revisions to the guidance to improve clarity 
and provide more detailed descriptions of our recommendations for 
electromagnetic compatibility testing and labeling.

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 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 statutes and regulations.

III. 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 PRA). 
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.

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 to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://wwww.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. 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 
Sonography and Jaw Tracking Devices'' by 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 ([numsign]). Follow the remaining voice 
prompts to complete your request.
    Persons interested in obtaining a copy of the guidance may also 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 manufacturer's 
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 guidance documents is available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/guidance.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: October 23, 2003.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 03-29864 Filed 12-1-03; 8:45 am]

BILLING CODE 4160-01-S