[Federal Register: February 12, 2002 (Volume 67, Number 29)]
[Notices]
[Page 6544-6545]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12fe02-83]
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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(PcO2) Monitors; Draft Guidance for Industry and FDA;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availability of the draft guidance entitled ``Class II Special Controls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Oxygen (PcO2) Monitors; Draft Guidance for Industry and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 This draft guidance will serve as a special control for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 This draft guidance is neither final nor is it in effect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diskette of the draft guidance document entitled ``Class II Special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and Oxygen (PcO2) Monitors; Draft Guidance for Industry and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