[Federal Register: November 12, 2002 (Volume 67, Number 218)]
[Notices]
[Page 68675-68676]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12no02-102]
-----------------------------------------------------------------------
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