[Federal Register: December 13, 2002 (Volume 67, Number 240)]
[Rules and Regulations]
[Page 76678-76681]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13de02-5]
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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