[Federal Register Volume 65, Number 185 (Friday, September 22, 2000)]
[Notices]
[Pages 57355-57356]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-24336]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1458]


Draft Guidance for Infant/Child Apnea Monitor 510(k) Submissions; 
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availability of the draft guidance entitled ``Guidance for Infant/Child 
Apnea Monitor 510(k) Submissions.'' This guidance is not final nor is 
it in effect at this time. This draft guidance describes minimum 
performance, testing, labeling, and clinical criteria for the infant/
child monitor. Upon considering comments on the draft document, FDA 
will modify the

[[Page 57356]]

guidance so that it is applicable to apnea monitors for patients of all 
ages. Elsewhere in this issue of the Federal Register, FDA is proposing 
to classify the apnea monitor into class II with this guidance document 
as the special control. FDA is issuing this draft guidance because the 
agency believes it is necessary to provide reasonable assurance of the 
safety and effectiveness of the apnea monitor.

DATES: Submit written comments on the draft guidance by December 21, 
2000.

ADDRESSES: Submit written requests for single copies on a 3.5" diskette 
of the draft guidance document entitled ``Guidance for Infant/Child 
Apnea Monitor 510(k) Submissions'' to the Division of Small 
Manufacturers 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 your request to 301-443-8818. Submit 
written comments on the draft guidance to the Dockets Management Branch 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. See the 
SUPPLEMENTARY INFORMATION section for information on electronic access 
to the guidance.

FOR FURTHER INFORMATION CONTACT: Joanna H. Weitershausen, Center for 
Devices and Radiological Health (HFZ-450), Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-
8609, ext. 164.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of February 21, 1995 (60 FR 9762), FDA 
issued a proposed rule setting forth requirements for a mandatory 
performance standard for the infant apnea monitor (hereinafter referred 
to as the 1995 proposal). Elsewhere in this issue of the Federal 
Register, FDA is withdrawing the 1995 proposal. Because of reduced 
mortality rates for infants at risk for death due to apparent life-
threatening events, and after considering other factors, FDA no longer 
believes that a mandatory performance standard is needed for this class 
II device.
    In conjunction with the withdrawal of the 1995 proposal, FDA is 
proposing also to create a separate classification for the apnea 
monitor device. This proposal, which also appears elsewhere in this 
issue of the Federal Register, will remove apnea monitors from their 
current classification within the generic type of device known as the 
breathing (ventilatory) frequency monitor (21 CFR 868.2375). The 
proposed rule will classify the apnea monitor as a group in class II 
(special controls), with an industry guidance document issued by FDA as 
the special control. The generic apnea monitor will include devices 
used to monitor apnea, i.e., the cessation of breathing, in all patient 
populations. The infant/child apnea monitor used on infants and 
children under 3 years of age will fall within the generic type of 
device proposed for classification as the apnea monitor.
    The draft guidance describes minimum performance characteristics, 
testing procedures and criteria, labeling, and, as appropriate, 
clinical testing recommendations for infant/child apnea monitors. After 
considering comments on this draft guidance and further evaluating 
appropriate clinical study parameters, FDA intends to modify the 
guidance so that the final guidance document is applicable as the 
special control for the apnea monitor used on patients in other age 
groups, as well as infants and children.

II. Significance of Guidance

    This guidance document represents the agency's current thinking on 
infant/child apnea monitor 510(k) submissions. 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 applicable statute, regulations, or both. As noted above, 
the agency believes the performance, testing, labeling, and clinical 
criteria in this draft guidance are applicable as well to apnea 
monitors used on patients of other ages. FDA intends to modify the 
final guidance document accordingly. FDA invites comments on how this 
guidance may be adapted to apply to apnea monitors used on patients 
other than infants and children.
    The agency has adopted good guidance practices (GGP's), which set 
forth the agency's policies and procedures for the development, 
issuance, and use of guidance documents (62 FR 8961, February 27, 
1997). This guidance document is issued as a Level 1 guidance 
consistent with GGP's.

III. Electronic Access

    In order to receive the draft guidance entitled ``Guidance for 
Infant/Child Apnea Monitor 510(k) Submissions'' 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 and enter the 
document number (1178) followed by the pound sign (#). 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 access to the Internet. Updated 
on a regular basis, the Center for Devices and Radiological Health 
(CDRH) home page includes ``Guidance for Infant/Child Apnea Monitor 
510(k) Submissions,'' 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 for Infant/Child Apnea Monitor 510(k) Submissions'' is 
available at http://www.fda.gov/cdrh/ode.

IV. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments regarding this draft guidance by 
December 21, 2000. 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 heading of 
this document. The draft guidance and received comments may be seen in 
the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.

    Dated: September 1, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-24336 Filed 9-21-00; 8:45 am]
BILLING CODE 4160-01-F