[Federal Register Volume 67, Number 29 (Tuesday, February 12, 2002)]
[Notices]
[Pages 6544-6545]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-3280]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0577]


Medical Devices; Class II Special Controls Guidance Document: 
Cutaneous Carbon Dioxide (PcCO2) and Oxygen 
(PcO2) Monitors; Draft Guidance for Industry and FDA; 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availability of the draft guidance entitled ``Class II Special Controls 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: Cutaneous Carbon Dioxide (PcCO2) and 
Oxygen (PcO2) Monitors; Draft Guidance for Industry and 
FDA.'' This draft guidance will serve as a special control for 
cutaneous carbon dioxide (PcCO2) and cutaneous oxygen 
(PcO2) monitor devices. Elsewhere in this issue of the 
Federal Register, FDA is publishing a proposed rule to reclassify these 
device types. This draft guidance is neither final nor is it in effect 
at this time.

DATES: Submit written or electronic comments on this guidance by May 
13, 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diskette of the draft guidance document entitled ``Class II Special 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: Cutaneous Carbon Dioxide (PcCO2) 
and Oxygen (PcO2) Monitors; Draft Guidance for Industry and 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 your request to 301-443-8818. See the 
SUPPLEMENTARY INFORMATION section for information on electronic 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. Submit electronic comments to 
http://www.fda.gov/dockets/ecomments. Comments should be identified 
with the docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: William A. Noe, Center for Devices and 
Radiological Health (HFZ-450), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-443-8609, ext. 174.

SUPPLEMENTARY INFORMATION:

I. Background

    This draft guidance document describes a means by which cutaneous 
carbon dioxide (PcCO2) and cutaneous oxygen 
(PcO2) monitor devices may comply with the requirement of 
special controls for class II devices. Designation of this guidance 
document as a special control means that manufacturers attempting to 
establish that their device is substantially equivalent to a predicate 
carbon dioxide (PcCO2) or oxygen (PcO2) monitor 
device must demonstrate that the proposed device complies with either 
the specific recommendations of this guidance or some alternate control 
that provides equivalent assurances of safety and effectiveness.

II. Significance of Guidance

    This draft 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: Cutaneous Carbon Dioxide (PcCO2) and Oxygen (PcO2) 
Monitors; Draft 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 ``Class II Special Controls Guidance Document: 
Cutaneous Carbon Dioxide (PcCO2) and Oxygen 
(PcO2) Monitors; 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 (1335) 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.

[[Page 6545]]

 Updated on a regular basis, the CDRH Web site 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 Web site 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.

IV. Comments

    Interested persons may submit to Dockets Management Branch (address 
above) written or electronic comments on the draft guidance by May 13, 
2002. Submit two copies of any comments, except individuals may submit 
one copy. Identify comments with the docket number found in brackets in 
the heading of this document. The guidance document and comments 
received may be seen in the Dockets Management Branch between 9 a.m. 
and 4 p.m., Monday through Friday.

    Dated: January 29, 2002.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-3280 Filed 2-11-02; 8:45 am]
BILLING CODE 4160-01-S