[Federal Register: August 14, 2002 (Volume 67, Number 157)]
[Notices]
[Page 53005-53006]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14au02-119]
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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Dental Sonography and Jaw Tracking Devices; Draft Guidance for Industry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availability of the draft guidance entitled ``Class II Special Controls
Guidance Document: Dental Sonography and Jaw Tracking Devices; Draft
Guidance for Industry and FDA Reviewers.'' This draft guidance document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DATES: Submit written or electronic comments on the draft guidance by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diskette of the draft guidance document entitled ``Class II Special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Draft Guidance for Industry and FDA Reviewers'' to the Division of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Submit written comments concerning this draft guidance to the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