Food and Drug Administration, HHS.
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.
Submit written or electronic comments on the guidance at any time. General comments on agency guidance documents are welcome at any time.
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.Start Further Info
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.End Further Info End Preamble Start Supplemental Information
In the Federal Register of April 5, 2002 (67 FR 16406), FDA announced the availability of this draft guidance document and invited interested persons to comment on it by July 5, 2002.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 This guidance supersedes the draft guidance entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and Obstructive Sleep Apnea; Guidance for Industry and FDA.”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 (#). Follow the remaining voice prompts to complete your request.Start Printed 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.
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.Start Signature
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