[Federal Register: July 17, 2002 (Volume 67, Number 137)]
[Notices]
[Page 46992-46993]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17jy02-94]
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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announced the availability of this draft guidance document and invited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