[Federal Register Volume 67, Number 240 (Friday, December 13, 2002)]
[Notices]
[Pages 76749-76750]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-31441]


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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 and Oxygen Monitors; 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: Cutaneous Carbon Dioxide (PcCO2) and 
Oxygen (PcO2) Monitors; Guidance for Industry and FDA.'' 
This guidance document describes a means by which PcCO2 
monitors and the PcO2 monitor 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 
reclassifying the PcCO2 monitor from class II (performance 
standards) into class II (special controls), the PcO2 
monitor for an infant

[[Page 76750]]

patient who is not under gas anesthesia from class II (performance 
standards) into class II (special controls), and the PcO2 
monitor for all other uses from class III (premarket approval) into 
class II (special controls).

DATES: Submit written or electronic comments on this guidance at any 
time. General comments on agency guidances are welcome at any time.

ADDRESSES: Submit written requests for single copies on a 3.5'' 
diskette of the guidance document entitled ``Class II Special Controls 
Guidance Document: Cutaneous Carbon Dioxide (PcCO2) and Oxygen (PcO2) 
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 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. 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.

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

    In the Federal Register of February 12, 2002 (67 FR 6444), FDA 
published a proposed rule to reclassify the PcCO2 monitor 
from class II (performance standards) into class II (special controls), 
the PcO2 monitor for an infant patient who is not under gas 
anesthesia from class II (performance standards) into class II (special 
controls), and the PcO2 monitor for all other uses from 
class III (premarket approval) into class II (special controls).
    In the Federal Register of February 12, 2002 (67 FR 6544), FDA also 
identified the document ``Class II Special Controls Guidance Document: 
Cutaneous Carbon Dioxide (PcCO2) and Oxygen 
(PcO2) Monitors; Draft Guidance for Industry and FDA'' as 
the special control capable of providing reasonable assurance of safety 
and effectiveness for these devices. This guidance document describes a 
means by which PcCO2 and PcO2 monitors may comply 
with the requirement of special controls for class II devices. 
Designation of this guidance document as a special control means that a 
manufacturer attempting to establish that its device is substantially 
equivalent to a predicate class II monitor 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.
    Interested persons were invited to comment on the draft guidance by 
May 13, 2002. FDA received two comments on the draft guidance document. 
The comments, from manufacturers, suggested that the draft guidance 
does not cite current voluntary consensus standards applicable to the 
devices subject to this guidance. FDA considered the comments and 
revised the guidance where we believe appropriate. FDA also clarified 
the description of the risks to health, in order to relate the risks 
more directly to the recommended mitigation measures.

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: Cutaneous Carbon Dioxide (PcCO2) and Oxygen 
(PcO2) 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 ``Class II Special Controls Guidance Document: 
Cutaneous Carbon Dioxide (PcCO2) and Oxygen 
(PcO2) Monitors; 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 ([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 on the Dockets Management Branch 
Internet site at http://www.fda.gov/ohrms/dockets.

IV. Paperwork Reduction Act of 1995

    The premarket notification information collections addressed in the 
guidance have been approved by the Office of Management and Budget 
(OMB) under the Paperwork Reduction Act of 1995 (PRA) under OMB control 
number 0910-0120. The labeling provisions addressed in the guidance 
have been approved by OMB under the PRA under OMB control number 0910-
0485.

V. Comments

    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written or electronic comments on the guidance. 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 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: December 2, 2002.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-31441 Filed 12-12-02; 8:45 am]
BILLING CODE 4160-01-S