[Federal Register Volume 67, Number 66 (Friday, April 5, 2002)]
[Notices]
[Pages 16406-16407]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-8348]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0011]


Medical Devices: Draft Guidance on Class II Special Controls 
Guidance Document: Intraoral Devices for Snoring and/or Obstructive 
Sleep Apnea; Draft Guidance for Industry and FDA; Availability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availability of the draft guidance entitled ``Class II Special Controls 
Guidance Document: Intraoral Devices for Snoring and/or Obstructive 
Sleep Apnea; Draft Guidance for Industry and FDA.'' This draft guidance 
document was developed as a special control to support the 
classification of intraoral devices for snoring and intraoral devices 
for snoring and obstructive sleep apnea into class II and to provide 
guidance to manufacturers attempting to establish that their intraoral 
devices for snoring and obstructive sleep apnea are substantially 
equivalent to a predicate device. Elsewhere in this issue of the 
Federal Register, FDA is publishing a proposed rule to classify these 
devices. This draft guidance is neither final nor is it in effect at 
this time.

DATES: Submit written or electronic comments concerning this draft 
guidance by July 5, 2002.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diskette of the draft guidance document entitled ``Class II Special 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: Intraoral Devices for Snoring and/or 
Obstructive Sleep Apnea; Draft Guidance for Industry and FDA'' to the 
Division of Small Manufacturers, International and Consumer Assistance 
(HFZ-220), Center for Devices and Radiological Health (CDRH), 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concerning the draft guidance to the Dockets Management Branch (HFA-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 
information on electronic access to the guidance.

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

    FDA is announcing the availability of a draft guidance entitled 
``Class II Special Controls Guidance Document: Intraoral Devices for 
Snoring and/or Obstructive Sleep Apnea; Draft Guidance for Industry and 
FDA.'' Intraoral devices to treat snoring are removable medical devices 
that are fitted in the patient's mouth to reduce or eliminate snoring. 
In some cases the devices may also be used to treat obstructive sleep 
apnea. Currently, intraoral devices for snoring and/or sleep apnea are 
unclassified. FDA is proposing to classify these devices into class II. 
FDA intends that the draft guidance document, if finalized, will serve 
as the special control for intraoral devices for snoring and/or 
obstructive sleep apnea. The draft guidance document offers 
recommendations to the regulated industry and FDA staff about the 
content and format of a premarket notification submission (510(k)) for 
such devices in order to establish safety and effectiveness. The draft 
guidance document is intended to facilitate the assembly of necessary 
data, maintain consistency of reviews, and provide for a more efficient 
regulatory process.

II. Significance of Guidance

    The draft guidance represents the agency's current thinking on 
intraoral devices for snoring and 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

[[Page 16407]]

such approach satisfies the applicable statutes and regulations.
    The draft guidance document is being issued consistent with FDA's 
good guidance practices (GGPs) regulation (21 CFR 10.115). The draft 
guidance document is issued as a level 1 guidance in accordance with 
the GGP regulations.

III. Electronic Access

    In order to receive ``Class II Special Controls Guidance Document: 
Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; 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 1378 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' 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 on the Dockets Management 
Branch Internet site at http://www.fda.gov/ohrms/dockets/default.htm.

IV. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written or electronic comments regarding the draft 
guidance by July 5, 2002. Submit two copies of any comments, 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 document and received comments may be seen 
in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: February 28, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-8348 Filed 4-4-02; 8:45 am]
BILLING CODE 4160-01-S