[Federal Register Volume 66, Number 221 (Thursday, November 15, 2001)]
[Rules and Regulations]
[Pages 57366-57368]
From the Federal Register Online via the Government Printing 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