[Federal Register Volume 67, Number 240 (Friday, December 13, 2002)]
[Rules and Regulations]
[Pages 76678-76681]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-31442]


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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 
and the Cutaneous Oxygen Monitor

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is reclassifying the 
cutaneous carbon dioxide (PcCO2) monitor from class II 
(performance standards) into class II (special controls). FDA is also 
reclassifying 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 
reclassifying 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 guidance document entitled ``Class 
II

[[Page 76679]]

Special Controls Guidance Document: Cutaneous Carbon Dioxide 
(PcCO2) and Oxygen (PcO2) Monitors; Guidance for 
Industry and FDA'' that will serve as the special control for the 
devices. These reclassifications are taken on the agency's own 
initiative based on new information. These actions are being taken 
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 (the SMDA), the Food and Drug 
Administration Modernization Act of 1997 (FDAMA), and the Medical 
Device User Fee and Modernization Act.

DATES: This rule is effective January 13, 2003.

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

    The act (21 U.S.C. 301 et. seq.), as amended by the 1976 amendments 
(Public Law 94-295), the SMDA (Public Law 101-629), and FDAMA (Public 
Law 105-115), established a comprehensive system for the regulation of 
medical devices intended for human use. Section 513 of the act (21 
U.S.C. 360c) established three categories (classes) of devices, 
depending on the regulatory controls needed to provide reasonable 
assurance of their safety and effectiveness. The three categories of 
devices are class I (general controls), class II (special controls), 
and class III (premarket approval).
    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. The 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 appropriate actions the agency deems 
necessary (section 513(a)(1)(B) of the act).
    It is the agency's position that it is not necessary to obtain a 
new classification recommendation from a panel that had recommended 
classification into class II prior to the SMDA. If a panel recommended 
that a device be classified into class II under the 1976 definition of 
class II, which included only performance standards as a class II 
control, clearly the Panel's recommendation for class II status would 
not change if controls, in addition to performance standards, could be 
added.
    Under section 513 of the act, devices that were in commercial 
distribution before May 28, 1976 (the date of enactment of the 1976 
amendments), generally referred to as preamendments devices, are 
classified after FDA has: (1) Received a recommendation from a device 
classification panel (an FDA advisory committee); (2) published the 
panel's recommendation for comment, along with a proposed regulation 
classifying the device; and (3) published a final regulation 
classifying the device. FDA has classified most preamendments devices 
under these procedures.
    Devices that were not in commercial distribution prior to May 28, 
1976, generally referred to as postamendments devices, are classified 
automatically by statute (section 513(f) of the act) into class III 
without any FDA rulemaking process. Those devices remain in class III 
and require premarket approval, unless and until: (1) The device is 
reclassified into class I or II; (2) FDA issues an order classifying 
the device into class I or II in accordance with section 513(f)(2) of 
the act, as amended by FDAMA; or (3) FDA issues an order finding the 
device to be substantially equivalent, in accordance with section 
513(i) of the act, to a predicate device that does not require 
premarket approval. The agency determines whether new devices are 
substantially equivalent to previously offered devices by means of 
premarket notification procedures in section 510(k) of the act (21 
U.S.C. 360(k)) and part 807 of the regulations (21 CFR part 807).
    A preamendments device that has been classified into class III may 
be marketed, by means of premarket notification procedures, without 
submission of a premarket approval application (PMA) until FDA issues a 
final regulation under section 515(b) of the act (21 U.S.C. 360e(b)) 
requiring premarket approval.
    Reclassification of classified preamendments devices is governed by 
section 513(e) of the act. This section provides that FDA may, by 
rulemaking, reclassify a device (in a proceeding that parallels the 
initial classification proceeding) based upon ``new information.'' The 
reclassification can be initiated by FDA or by the petition of an 
interested person. The term ``new information,'' as used in section 
513(e) of the act, includes information developed as a result of a 
reevaluation of the data before the agency when the device was 
originally classified, as well as information not presented, not 
available, or not developed at that time. (See, e.g., Holland Rantos v. 
United States Department of Health, Education, and Welfare, 587 F.2d 
1173, 1174 n.1 (D.C. Cir. 1978); Upjohn v. Finch, 422 F.2d 944 (6th 
Cir. 1970); Bell v. Goddard, 366 F.2d 177 (7th Cir. 1966).)
    Reevaluation of the data previously before the agency is an 
appropriate basis for subsequent regulatory action where the 
reevaluation is made in light of newly available regulatory authority 
(see Bell v. Goddard, supra, 366 F.2d at 181; Ethicon, Inc. v. FDA, 762 
F. Supp. 382, 389-91 (D.D.C. 1991)), or in light of changes in 
``medical science.'' (See Upjohn v. Finch, supra, 422 F.2d at 951.) 
Regardless of whether data before the agency are past or new data, the 
``new information'' on which any reclassification is based is required 
to consist of ``valid scientific evidence,'' as defined in section 
513(a)(3) of the act and 21 CFR 860.7(c)(2). (See, e.g., General 
Medical Co. v. FDA, 770 F.2d 214 (D.C. Cir. 1985); Contact Lens Assoc. 
v. FDA, 766 F.2d 592 (D.C. Cir.), cert. denied, 474 U.S. 1062 (1985). 
FDA relies upon ``valid scientific evidence'' in the classification 
process to determine the level of regulation for devices. For the 
purpose of reclassification, the valid scientific evidence upon which 
the agency relies must be publicly available. Publicly available 
information excludes trade secret and/or confidential commercial 
information, e.g., the contents of a pending premarket approval 
application (PMA). (See section 520(c) of the act (21 U.S.C. 360j(c).)
    In accordance with section 513(e) of the act and 21 CFR 
860.130(b)(1), based on new information with respect to the device, 
FDA, on its own initiative, is reclassifying the PcCO2 
monitor from class II (performance standards) into class II (special 
controls). FDA is also reclassifying 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).
    FDAMA added a new section 510(m) to the act. Section 510(m) of the 
act provides that a class II device may be

[[Page 76680]]

exempted from the premarket notification requirements under section 
510(k), if the agency determines that premarket notification is not 
necessary to assure the safety and effectiveness of the device. FDA has 
determined that premarket notification is necessary to assure the 
safety and effectiveness of the PcCO2 monitor and the 
PcO2 monitor.

II. Regulatory History of the Device

    In the Federal Register of February 12, 2002 (67 FR 6444), FDA 
published a proposed rule reclassifying 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), on the 
agency's own initiative based on new information.
    FDA also identified the document ``Class II Special Controls 
Guidance Document: Cutaneous Carbon Dioxide (PcCO2) and 
Oxygen (PcO2) Monitors; Guidance for Industry and FDA'' as 
the special control applicable to these devices.
    Interested persons were invited to comment on the proposed rule by 
April 15, 2002, and on the draft special control guidance document by 
May 13, 2002. FDA received no comments on the proposed rule. FDA 
received two comments on the draft guidance document and they are 
discussed in the notice of availability for the guidance published 
elsewhere in this issue of the Federal Register.
    Based on a review of the available information, FDA concludes that 
the guidance document ``Class II Special Controls Guidance Document: 
Cutaneous Carbon Dioxide (PcCO2) and Oxygen 
(PcO2) Monitors; Guidance for Industry and FDA,'' in 
conjunction with general controls, provides reasonable assurance of the 
safety and effectiveness of these devices. Following the effective date 
of this final rule, any firm submitting a 510(k) premarket notification 
for the PcCO2 monitor or the PcO2 monitor will 
need to address the issues covered in the special control guidance. 
However, the firm need only show that its device meets the 
recommendations of the guidance or in some other way provides 
equivalent assurances of safety and effectiveness. Elsewhere in this 
issue of the Federal Register, FDA is announcing the availability of 
the guidance document.

III. Summary of Final Rule

    FDA is adopting the assessment of the risks to public health stated 
in the proposed rule published on February 12, 2002. Furthermore, FDA 
is issuing a final rule that revises Sec. Sec.  868.2480 and 868.2500, 
thereby reclassifying the generic type of device, PcCO2 
monitor, from class II (performance standards) into class II (special 
controls) and the generic type of device, PcO2 monitor, for 
an infant patient who is not under gas anesthesia from class II 
(performance standards) into class II (special controls), and for all 
other uses, from class III (premarket approval) into class II (special 
controls). The special control capable of providing reasonable 
assurance of safety and effectiveness for these devices is a guidance 
document 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 and 
PcO2 monitor devices may comply with the requirement of 
special controls for class II devices. Following the effective date of 
this final rule, any firm submitting a premarket notification (510(k)) 
for a PcCO2 monitor or PcO2 monitor will need to 
address the issues covered in the special control guidance. However, 
the firm need only show that its device meets the recommendations of 
the guidance or in some other way provides equivalent assurances of 
safety and effectiveness.
    For the convenience of the reader, FDA is adding new Sec.  868.1(e) 
to inform the reader where to find guidance documents referenced in 21 
CFR part 868.

IV. 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.

V. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866, the Regulatory Flexibility Act (5 U.S.C 601-612), and the 
Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1501 et. seq.). 
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 final 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 the cutaneous oxygen monitor 
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. Furthermore, this rule may permit small potential 
competitors to enter the marketplace by lowering their costs.
    Compliance with special controls for the cutaneous oxygen monitor 
and the cutaneous carbon dioxide monitor will not impose significant 
new costs on affected manufacturers because most of these devices 
already comply with the special controls. Based upon its review of the 
information submitted in premarket notifications for these devices, FDA 
believes that manufacturers presently marketing these devices are in 
conformance with the guidance document. The guidance document assures 
that, in the future, these generic types of devices will be at least as 
safe and effective as the presently marketed devices. These devices are 
already subject to premarket notification and labeling requirements. 
The guidance document advises manufacturers on appropriate means of 
complying with these requirements.
    The agency, therefore, certifies that this final rule will not have 
a significant economic impact on a substantial number of small 
entities. In addition, this 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.

VI. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and

[[Page 76681]]

responsibilities among the various levels of government. Accordingly, 
the agency has concluded that the rule does not contain policies that 
have federalism implications as defined in the Executive order and, 
consequently, a federalism summary impact statement is not required.

VII. Paperwork Reduction Act of 1995

    The final rule contains no collections of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) (the PRA) is not 
required.
    The information collections addressed in the special control 
guidance document identified by this rule have been approved by OMB in 
accordance with the PRA under the regulations governing premarket 
notification submissions (part 807, subpart E, OMB control number 0910-
0120). The labeling provisions addressed in the guidance have been 
approved by OMB in accordance with the PRA under OMB control number 
0910-0485.

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, 21 CFR part 
868 is amended as follows:

PART 868--ANESTHESIOLOGY DEVICES

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

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

    2. Section 868.1 is amended by adding paragraph (e) to read as 
follows:


Sec.  868.1  Scope.

* * * * *
    (e) Guidance documents referenced in this part are available on the 
Internet at http://www.fda.gov/cdrh/guidance.html.

    3. 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; Guidance for Industry and FDA.'' See Sec.  
868.1(e) for the availability of this guidance document.
    4. Section 868.2500 and the section heading 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.'' See Sec.  
868.1(e) for the availability of this guidance document.

    Dated: December 2, 2002.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-31442 Filed 12-12-02; 8:45 am]
BILLING CODE 4160-01-S