[Federal Register Volume 67, Number 137 (Wednesday, July 17, 2002)]
[Notices]
[Pages 46992-46993]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-17958]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1458]


Medical Devices: Class II Special Controls Guidance Document: 
Apnea Monitors; 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 guidance entitled ``Class II Special Controls 
Guidance Document: Apnea Monitors; Guidance for Industry and FDA.'' 
This document describes a means by which apnea monitors may comply with 
the requirement of special controls for class II devices. Elsewhere in 
this issue of the Federal Register, FDA is publishing a final rule 
classifying apnea monitors into class II (special controls).

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 Document: 
Apnea Monitors; 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 labels to assist that office in processing your request, or 
fax your request to 301-443-8818.
    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 brackets in the heading of this document. 
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: William Noe, Center for Devices and 
Radiological Health (HFZ-450), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-443-8609.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of September 22, 2000 (65 FR 57355), FDA 
announced the availability of this draft guidance document and invited 
interested persons to comment on it by December 21, 2000. FDA also 
announced in that notice its intention to modify the guidance so that 
it would apply to apnea monitors for patients of all ages. In that same 
issue of the Federal Register (65 FR 57301), FDA proposed to classify 
the apnea monitor into class II with this guidance document as the 
special control. This guidance supersedes the draft guidance entitled 
``Guidance for Infant/Child Apnea Monitor 510(k) Submissions.''
    FDA received comments on the draft guidance from one manufacturer. 
We considered this manufacturer's comments and included some of its 
suggestions in our revised guidance. We revised the guidance to make it 
applicable to devices intended for adults as well as infants and 
children, added information concerning industry's option to submit an 
abbreviated 510(k) when relying on a class II special controls guidance 
document, and retitled the guidance to reflect these changes.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on ``Class II Special Controls Guidance 
Document: Apnea Monitors; Guidance for Industry and FDA.'' 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 the guidance entitled ``Class II Special 
Controls Guidance Document: Apnea Monitors; Guidance for Industry and 
FDA'' via your fax machine, call the Center for Devices and 
Radiological Health (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 (1178) followed by the pound sign ([numsign]). Follow 
the remaining voice prompts to complete your request.
    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 at http://www.fda.gov/ohrms/dockets.

IV. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collection of information in the labeling section of this guidance 
discussing labeling under 21 CFR 807.87(e) was approved under OMB 
control number 0910-0120. The collection of information in the labeling 
section of this guidance discussing labeling under 21 CFR 801.109 was 
approved under OMB control number 0910-0485.

V. 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. Comments are to be identified with the 
docket number found in brackets in the

[[Page 46993]]

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: July 5, 2002.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-17958 Filed 7-16-02; 8:45 am]
BILLING CODE 4160-01-S