[Federal Register Volume 67, Number 29 (Tuesday, February 12, 2002)]
[Proposed Rules]
[Pages 6444-6447]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-3281]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 868

[Docket No. 01N-0576]


Medical Devices; Reclassification of the Cutaneous Carbon Dioxide 
(PcCO2) and the Cutaneous Oxygen (PcO2) Monitor

AGENCY: Food and Drug Administration, HHS.

[[Page 6445]]


ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to 
reclassify the cutaneous carbon dioxide (PcCO2) monitor from 
class II (performance standards) into class II (special controls). FDA 
is also proposing to reclassify the cutaneous oxygen (PcO2) 
monitor for an infant patient who is not under gas anesthesia from 
class II (performance standards) into class II (special controls) and 
is reproposing the reclassification of the cutaneous oxygen 
(PcO2) monitor for all other uses from class III (premarket 
approval) into class II (special controls). Elsewhere in this issue of 
the Federal Register, FDA is announcing the availability of the draft 
guidance document entitled ``Class II Special Controls Guidance 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(PcO2) Monitors; Draft Guidance for Industry and FDA'' which 
would serve as the special control if this proposal becomes final.
    These reclassifications are being undertaken on the agency's own 
initiative based on new information under the Federal Food, Drug, and 
Cosmetic Act (the act), as amended by the Medical Device Amendments of 
1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 
(SMDA), and the Food and Drug Administration Modernization Act of 1997.

DATES: Submit written or electronic comments on the proposed rule by 
April 15, 2002. See section IV of this document for the proposed 
effective date of a final rule based on this document.

ADDRESSES: Submit written comments to the Docket 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.

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

A. Cutaneous Carbon Dioxide (PcCO2) Monitor

    In the Federal Register of July 25, 1988 (53 FR 27878), FDA issued 
for public comment the recommendation of the Anesthesiology and 
Respiratory Therapy Devices Panel that FDA reclassify the cutaneous 
carbon dioxide (PcCO2) monitor from class III into class II. 
On December 9, 1988, FDA sent to all known manufacturers of the device 
a letter (order) that classified the cutaneous carbon dioxide monitor, 
and substantially equivalent devices of this generic type, from class 
III to class II. In the Federal Register of June 28, 1989 (54 FR 
27160), FDA published a final rule reclassifying the cutaneous carbon 
dioxide monitor from class III (premarket approval) into class II 
(performance standards) and added new 21 CFR 868.2480 Cutaneous carbon 
dioxide (PcCO2) monitor.

B. Cutaneous Oxygen (PcO2) Monitor

    In the Federal Register of November 2, 1979 (44 FR 63292), FDA 
published a proposal to classify 149 anesthesiology devices, including 
the cutaneous oxygen monitor (Sec. 868.2500). In the Federal Register 
of July 16, 1982 (47 FR 31130), FDA published a final rule classifying 
the cutaneous oxygen monitor into either class II or class III, 
depending on the intended use of the device. The cutaneous oxygen 
monitor intended for use in monitoring infant patients who are not 
under gas anesthesia was classified as class II (performance 
standards). This action was based on FDA's belief that there was 
sufficient data to show the device is safe and effective for this use 
and that a performance standard would provide reasonable assurance of 
safety and effectiveness of the device. The final rule also classified 
into class III the cutaneous oxygen monitor intended for all other 
uses, that is, in a noninfant patient or in any patient, including an 
infant, who is under gas anesthesia
    In the Federal Register of August 14, 1995 (60 FR 41984 and 41986), 
FDA published two orders for certain class III devices requiring the 
submission of safety and effectiveness information in accordance with 
the preamendments class III strategy for implementing section 515(i) of 
the act (21 U.S.C. 360e(i)), and providing deadlines for submission of 
the information. In response to that notice, on October 21, 1996, 
Radiometer Medical A/S submitted a request for reclassification of the 
cutaneous oxygen monitor for use in noninfant patients not under gas 
anesthesia.
    In the Federal Register of March 15, 1999 (64 FR 12774), FDA 
published a proposed rule to reclassify 38 preamendments class III 
devices into class II and to establish special controls for these 
devices. Among the 38 preamendments devices was the cutaneous oxygen 
monitor intended for all uses other than in an infant patient who is 
not under gas anesthesia. An American Society for Testing and Materials 
standard was proposed as the special control. FDA invited interested 
persons to comment on the proposed rule by June 14, 1999. FDA received 
six comments and two requests for extension of the comment period for 
certain devices. One of the requests for extension of the comment 
period was from a manufacturer of the cutaneous oxygen monitor. The 
manufacturer recently withdrew this request. None of the comments 
addressed the cutaneous oxygen monitor.
    In the Federal Register of March 31, 2000 (63 FR 17138), FDA 
published a final rule reclassifying 28 of the 38 devices for which it 
had proposed reclassification. FDA reopened the comment period for 6 of 
the 38 devices (Vascular graft prosthesis of less than 6 millimeters 
diameter, 21 CFR 870.3450; Pacemaker lead adapter, 21 CFR 870.3620; 
Annuloplasty ring, 21 CFR 870.3800; Cardiopulmonary bypass defoamer, 21 
CFR 870.4230; Cardiopulmonary bypass arterial blood line filter, 21 CFR 
870.4260; and Cardiopulmonary bypass oxygenator, 21 CFR 870.4350) for 
which it had proposed reclassification and intends to reopen the 
comment period for 3 other devices in the near future. The remaining of 
the 38 preamendments devices is the cutaneous oxygen monitor. FDA is, 
in this notice, reproposing the reclassification of the cutaneous 
oxygen monitor for all other uses from class III (premarket approval) 
into class II (special controls).

II. Proposed Rule

    FDA is proposing to reclassify the cutaneous carbon dioxide 
(PcCO2) monitor and the cutaneous oxygen (PcO2) 
monitor intended for use in monitoring infant patients who are not 
under gas anesthesia, from class II (performance standards) into class 
II (special controls).
    Under the 1976 amendments, class II devices were defined as those 
devices for which there is insufficient information to show that 
general controls themselves will assure safety and effectiveness, but 
for which there is sufficient information to establish performance 
standards to provide such assurance. SMDA broadened the definition of 
class II devices to mean those devices for which there is insufficient 
information to show that general controls themselves will assure safety 
and effectiveness, but for which there is sufficient information to 
establish special controls to provide such assurance, including 
performance standards, postmarket surveillance, patient registries, 
development and dissemination of guidelines, recommendations, and any 
other

[[Page 6446]]

appropriate actions the agency deems necessary (section 513(a)(1)(B) of 
the act (21 U.S.C. 360c(a)(1)(B)). At the time the cutaneous carbon 
dioxide (PcCO2) monitor and the cutaneous oxygen 
(PcO2) monitor intended for use in monitoring infant 
patients who are not under gas anesthesia were classified, 1987 and 
1982 respectively, special controls were not a regulatory option. FDA 
has now developed a draft guidance and is proposing to make it the 
special control for these products.
    FDA is also reproposing the reclassification of the cutaneous 
oxygen monitor for all other uses from class III (premarket approval) 
into class II (special controls). In the original March 15, 1999, 
proposal, FDA had announced its tentative determination that 
classification into class II with four consensus standards as the 
special controls would provide reasonable assurance of the safety and 
effectiveness of the cutaneous oxygen monitor. The agency received no 
comments on the proposed reclassification of the cutaneous oxygen 
monitor. Under the SMDA authority, FDA is now proposing a guidance 
document as the special controls.
    FDA is identifying the guidance document entitled ``Class II 
Special Controls Guidance Document: Cutaneous Carbon Dioxide 
(PcCO2) and Oxygen (PcO2) Monitors; Draft 
Guidance for Industry and FDA'' that would serve as the special control 
for the cutaneous oxygen (PcO2) monitor for both intended 
uses and for the cutaneous carbon dioxide (PcCO2) monitor, 
if this proposal becomes final.
    The draft guidance document sets forth the information FDA believes 
should be included in a 510(k) for these devices. FDA has identified 
the following as the risks to health presented by these devices (first 
column of the table below). The second column identifies the portions 
of the guidance document that address these risks to health. FDA 
believes that addressing these risks to health in a 510(k) in the 
manner identified in the guidance document, or an acceptable 
alternative, is necessary to provide reasonable assurance of the safety 
and effectiveness of these devices.

                                Table 1.
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          Identified Risk              Recommended Mitigation Measures
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Electrical Shock                     Electrical Safety Standards
Electromagnetic Interference         Electromagnetic Compatibility
                                      Standards
Toxicity Tissue Reactivity           Biocompatibility and Sterility
                                      Guidance
Burns                                Biocompatibility and Sterility
                                      Guidance
Inaccurate Measurement               Performance Testing Requirements
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III. Special Controls

    The proposed special control for these devices is FDA's ``Class II 
Special Controls Guidance Document: Cutaneous Carbon Dioxide 
(PcCO2) and Oxygen (PcO2) Monitors; Draft 
Guidance for Industry and FDA.'' FDA is announcing the public 
availability of the draft guidance in a notice published elsewhere in 
this issue of the Federal Register and invites interested persons to 
comment.

IV. Proposed Dates

    FDA proposes that any final rule that may issue based on this 
proposal become effective 30 days after its date of publication in the 
Federal Register.

V. Environmental Impact

    The agency has determined under 21 CFR 25.34(b) that these 
classification actions are of a type that do not individually or 
cumulatively have a significant effect on the human environment. 
Therefore, neither an environmental assessment nor an environmental 
impact statement is required.

VI. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612) (as 
amended by subtitle D of the Small Business Regulatory Fairness Act of 
1996 (Public Law 104-121), and the Unfunded Mandates Reform Act of 1995 
(Public Law 104-4)). Executive Order 12866 directs agencies to assess 
all costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety, and other advantages; distributive impacts; and 
equity). The agency believes that this proposed rule is consistent with 
the regulatory philosophy and principles identified in the Executive 
order. In addition, the final rule is not a significant regulatory 
action as defined by the Executive order and so is not subject to 
review under the Executive order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Reclassification of these devices from class III 
will relieve all manufacturers of these devices of the cost of 
complying with the premarket approval requirements in section 515 of 
the act. Moreover, compliance with special controls proposed for these 
devices will not impose significant new costs on affected manufacturers 
because most of these devices already comply with the proposed special 
controls. Because reclassification will reduce regulatory costs with 
respect to these devices, it will impose no significant economic impact 
on any small entities, and it may permit small potential competitors to 
enter the marketplace by lowering their costs. The agency therefore 
certifies that this rule will not have a significant economic impact on 
a substantial number of small entities. In addition, this proposed rule 
will not impose costs of $100 million or more on either the private 
sector or State, local, and tribal governments in the aggregate, and 
therefore a summary statement of analysis under section 202(a) of the 
Unfunded Mandates Reform Act of 1995 is not required.

VII. Paperwork Reduction Act of 1995

    FDA concludes that this proposed rule contains no collection of 
information. Therefore, clearance by the Office of Management and 
Budget under the Paperwork Reduction Act of 1995 is not required.

VIII. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written or electronic comments regarding this proposed 
rule by April 15, 2002. Submit two copies of any comments, except 
individuals may submit one copy. Comments are to be identified with the 
docket number found in brackets in the heading of this document. The 
proposed rule and received comments may be seen in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

List of Subjects in 21 CFR Part 868

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR part 868 be amended as follows:

PART 868--ANESTHESIOLOGY DEVICES

    1. The authority citation for 21 CFR part 868 continues to read as 
follows:


[[Page 6447]]


    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    2. Section 868.2480 is amended by revising paragraph (b) to read as 
follows:


Sec. 868.2480  Cutaneous carbon dioxide (PcCO2) monitor.

* * * * *
    (b) Classification. Class II (special controls). The special 
control for this device is FDA's ``Class II Special Controls Guidance 
Document: Cutaneous Carbon Dioxide (PcCO2) and Oxygen 
(PcO2) Monitors; Final Guidance for Industry and FDA.''
    3. Section 868.2500 is revised to read as follows:


Sec. 868.2500  Cutaneous oxygen (PcO2) monitor.

    (a) Identification. A cutaneous oxygen (PcO2) monitor is 
a noninvasive, heated sensor (e.g., a Clark-type polargraphic 
electrode) placed on the patient's skin that is intended to monitor 
relative changes in the cutaneous oxygen tension.
    (b) Classification. Class II (special controls). The special 
control for this device is FDA's ``Class II Special Controls Guidance 
Document: Cutaneous Carbon Dioxide (PcCO2) and Oxygen 
(PcO2) Monitors; Guidance for Industry and FDA.''

    Dated: January 29, 2002.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-3281 Filed 2-11-02; 8:45 am]
BILLING CODE 4160-01-S