[Federal Register Volume 67, Number 218 (Tuesday, November 12, 2002)]
[Notices]
[Pages 68675-68676]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-28550]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0011]


Medical Devices; Class II Special Controls Guidance Document: 
Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance 
for Industry and FDA; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``Class II Special Controls 
Guidance Document: Intraoral Devices for Snoring and/or Obstructive 
Sleep Apnea; Guidance for Industry and FDA.'' This document provides 
recommendations for complying with the premarket notification 
requirements for these devices. Elsewhere in this issue of the Federal 
Register, FDA is publishing a final rule to classify these devices.

DATES: Submit written or electronic comments on the 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 entitled ``Class II Special Controls Guidance 
Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; 
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 you request to 
301-443-8818. See the SUPPLEMENTARY INFORMATION section for information 
on electric access to the guidance.
    Submit written comments concerning this guidance to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. Comments should be identified with 
the docket number found in the brackets in the heading of this 
document. Submit electronic comments to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Susan 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

    In the Federal Register of April 5, 2002 (67 FR 16406), FDA 
announced the availability of this draft guidance document and invited 
interested persons to comment on it by July 5, 2002. Also in the 
Federal Register of April 5, 2002 (67 FR 16338), FDA proposed to 
classify intraoral devices used to control or treat simple snoring and/
or obstructive sleep apnea into class II with this guidance document as 
the special control. This guidance supersedes the draft guidance 
entitled ``Class II Special Controls Guidance Document: Intraoral 
Devices for Snoring and Obstructive Sleep Apnea; Guidance for Industry 
and FDA.''
    FDA received one comment on the draft guidance from the National 
Association of Dental Laboratories. We considered this comment and 
agree that the guidance does not change the regulatory requirements for 
dental laboratories. We also revised the guidance to clarify how a 
manufacturer may submit an abbreviated 510(k) when relying on a class 
II special controls guidance document.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). This guidance represents the 
agency's current thinking on 510(k) submissions for intraoral devices 
for snoring and/or obstructive sleep apnea. 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.

III. Electronic Access

    In order to receive ``Class II Special Controls Guidance Document: 
Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; 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 (1378) followed 
by the pound sign ([numsign]). Follow the remaining voice prompts to 
complete your request.

[[Page 68676]]

    Persons interested in obtaining a copy of the 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 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. The CDRH home page 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 Dockets Management Branch 
Internet site at http://www.fda.gov/ohrms/dockets.

IV. Comments

    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written or electronic comments regarding this guidance at 
any time. Two copies of any comments are to be submitted, except that 
individuals may submit one copy. Identify comments with the docket 
number found in brackets in the heading of this document. The guidance 
document and received comments may be seen in the Dockets Management 
Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: October 28, 2002.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-28550 Filed 11-8-02; 8:45 am]
BILLING CODE 4160-01-S