[Federal Register: April 5, 2002 (Volume 67, Number 66)]
[Notices]
[Page 16406-16407]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05ap02-72]
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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Medical Devices: Draft Guidance on Class II Special Controls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Sleep Apnea; Draft Guidance for Industry and FDA; Availability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.
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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availability of the draft guidance entitled ``Class II Special Controls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: 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Sleep Apnea; Draft Guidance for Industry and FDA.'' This draft guidance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 This draft guidance is neither final nor is it in effect at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DATES: Submit written or electronic comments concerning this draft
guidance by July 5, 2002.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diskette of the draft guidance document entitled ``Class II Special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Obstructive Sleep Apnea; Draft Guidance for Industry and FDA'' to the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concerning the draft guidance to the Dockets Management Branch (HFA-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