[Federal Register Volume 66, Number 221 (Thursday, November 15, 2001)]
[Rules and Regulations]
[Pages 57366-57368]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-28561]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 868

[Docket No. 99N-0035]


Medical Devices; Reclassification of Three Anesthesiology 
Preamendments Class III Devices into Class II

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is reclassifying three 
anesthesiology preamendments devices from class III (premarket

[[Page 57367]]

approval) into class II (special controls). FDA is also identifying the 
special controls that the agency believes will reasonably ensure the 
safety and effectiveness of the devices. This reclassification is 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 Safe Medical Devices Act of 1990 and the FDA Modernization Act of 
1997.

DATES: This rule is effective December 17, 2001.

FOR FURTHER INFORMATION CONTACT: Christy Foreman, Division of 
Cardiovascular and Respiratory Devices (HFZ-450), Center for Devices 
and Radiological Health, Food and Drug Administration, 9200 Corporate 
Blvd., Rockville, MD 20850, 301-443-8609.

SUPPLEMENTARY INFORMATION:

I. Background

    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. FDA invited interested persons to comment on the proposed rule 
by June 14, 1999. FDA had not made the guidance documents that were 
proposed as special controls for the three anesthesiology devices 
available for comment through FDA's good guidance practices (GGPs). In 
the Federal Register of November 22, 2000, FDA announced the 
availability of two guidance documents for these devices (65 FR 70357) 
and reopened the comment period on the reclassification of the three 
devices (65 FR 70325) until February 20, 2001. FDA received no comments 
on the proposed reclassification of these three devices.
    In this final rule, FDA is reclassifying the three devices into 
class II with a guidance document entitled ``Class II Special Controls 
Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for 
Industry and FDA'' as the special control. The guidance document 
combines and supersedes ``Guidance for Electrical Safety, 
Electromagnetic Compatibility and Mechanical Testing for Indwelling 
Blood Gas Analyzer Premarket Notification Submissions'' and ``Guidance 
for Indwelling Blood Gas Analyzer 510(k) Submissions,'' which in turn 
incorporated the special controls listed separately in the proposed 
rule to reclassify these devices.
    The devices that are being reclassified in this final rule are:
     Indwelling blood carbon dioxide partial pressure 
(Pco2) analyzer (21 CFR 868.1150),
     Indwelling blood hydrogen ion concentration (pH) analyzer 
(21 CFR 868.1170), and
     Indwelling blood oxygen partial pressure (Po2) 
analyzer (21 CFR 868.1200).

II. FDA's Conclusion

    FDA has concluded, based on a review of the available information, 
that the guidance document ``Special Controls Guidance Document: 
Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA,'' 
in conjunction with general controls, provides reasonable assurance of 
the safety and effectiveness of these three devices. Elsewhere in this 
issue of the Federal Register, FDA is announcing the availability of 
the final guidance document.

III. Environmental Impact

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

IV. Analysis of Impacts

    FDA has examined the impacts of the 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 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 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 (21 U.S.C. 360e). 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 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.

V. 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 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 order and, consequently, a federalism 
summary impact statement is not required.

VI. Paperwork Reduction Act of 1995

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

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.

[[Page 57368]]

    2. Section 868.1150 is amended by revising paragraph (b) and by 
removing paragraph (c) to read as follows:


Sec. 868.1150  Indwelling blood carbon dioxide partial pressure 
(Pco2) analyzer.

* * * * *
    (b) Classification. Class II (special controls). The special 
control for this device is FDA's ``Class II Special Controls Guidance 
Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry 
and FDA.''
    3. Section 868.1170 is amended by revising paragraph (b) and by 
removing paragraph (c) to read as follows:


Sec. 868.1170  Indwelling blood hydrogen ion concentration (pH) 
analyzer.

* * * * *
    (b) Classification. Class II (special controls). The special 
control for this device is FDA's ``Class II Special Controls Guidance 
Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry 
and FDA.''
    4. Section 868.1200 is amended by revising paragraph (b) and by 
removing paragraph (c) to read as follows:


Sec. 868.1200  Indwelling blood oxygen partial pressure 
(Po2) analyzer.

* * * * *
    (b) Classification. Class II (special controls). The special 
control for this device is FDA's ``Class II Special Controls Guidance 
Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry 
and FDA.''

    Dated: November 4, 2001.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 01-28561 Filed 11-14-01; 8:45 am]
BILLING CODE 4160-01-S