![[logo] US EPA](http://www.epa.gov/epafiles/images/logo_epaseal.gif){kind=logo}
Medical Devices; Apnea Monitor; Special Controls
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: July 17, 2002 (Volume 67, Number 137)]
[Rules and Regulations]
[Page 46851-46852]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17jy02-11]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 868
[Docket No. 00N-1457]
Medical Devices; Apnea Monitor; Special Controls
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule
to create a separate classification for the apnea monitor. The device
currently is included in the generic type of device called breathing
frequency monitors. The apnea monitor will remain in class II, but will
be subject to a special control. The special control is an FDA guidance
document that identifies minimum performance, testing, and labeling
recommendations for the device. Following the effective date of this
final classification rule, any firm submitting a 510(k) premarket
notification for a ``new'' apnea 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 that will serve as
the special control. FDA is taking these actions because it believes
that they are necessary to provide reasonable assurance of the safety
and effectiveness of the apnea monitor.
DATES: This rule is effective October 15, 2002.
FOR FURTHER INFORMATION CONTACT: Joanna H. Weithershausen, Center for
Devices and Radiological Health (HFZ-450), Food and Drug
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-
8609, ext. 164.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of September 22, 2000 (65 FR 57301), FDA
published a proposed rule to create a separate classification for the
apnea monitor. FDA proposed that the apnea monitor remain in class II,
but be subject to a special control. The proposed special control was
an FDA guidance document that identified minimum performance, testing,
and labeling recommendations for the device.
In the same edition of the Federal Register, FDA withdrew its
proposed mandatory standard for infant apnea monitors (65 FR 57303) and
announced the availability of the draft guidance that FDA intended to
serve as the special control for the device (65 FR 57355).
FDA invited interested persons to comment on the proposed rule by
December 21, 2000. FDA received no comments. Based on a review of the
available information, referenced in the preamble to the proposed rule
and placed on file in FDA's Dockets Management Branch, FDA concludes
that special controls, in conjunction with general controls, provide
reasonable assurance of the safety and effectiveness of this device.
FDA has made some revisions to the identification paragraphs in
Secs. 868.2375 and 868.2377 for clarity. Otherwise, FDA is finalizing
the rule as proposed. Elsewhere in this issue of the Federal Register,
FDA is announcing the availability of the special control guidance.
II. Environmental Impact
The agency has determined under 21 CFR 25.34(b) that this action 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.
III. Analysis of Impacts
FDA has examined the impact of the final 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. Following the effective date of this final classification rule,
any firm submitting a 510(k) premarket notification for a ``new'' apnea
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.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. In the past 10 years, the agency estimates that it
has received, on average, approximately four 510(k) submissions per
year for breathing frequency monitor devices. FDA estimates that only
one or two of these submissions per year pertained to apnea monitor
devices.
Based on its review of these 510(k) submissions, FDA believes that
presently marketed apnea monitors conform to the guidance and,
therefore, the manufacturers of these devices will not have to take
further action because of this rule. New manufacturers of apnea
monitors will only need to submit 510(k)s, as the statute now requires
them to do, and demonstrate that they meet the recommendations of the
guidance or in some other way provide equivalent assurances of safety
and effectiveness. Therefore, the agency certifies that this final rule
will not have a significant economic impact on a substantial number of
small entities. In addition, this reclassification action will
[[Page 46852]]
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.
IV. 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 Executive order and, consequently, a
federalism summary impact statement is not required.
V. 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 to read 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 868.2375(a) is revised to read as follows:
Sec. 868.2375 Breathing frequency monitor.
(a) Identification. A breathing (ventilatory) frequency monitor is
a device intended to measure or monitor a patient's respiratory rate.
The device may provide an audible or visible alarm when the respiratory
rate, averaged over time, is outside operator settable alarm limits.
This device does not include the apnea monitor classified in
Sec. 868.2377.
* * * * *
3. Section 868.2377 is added to subpart C to read as follows:
Sec. 868.2377 Apnea monitor.
(a) Identification. An apnea monitor is a complete system intended
to alarm primarily upon the cessation of breathing timed from the last
detected breath. The apnea monitor also includes indirect methods of
apnea detection such as monitoring of heart rate and other
physiological parameters linked to the presence or absence of adequate
respiration.
(b) Classification. Class II (special controls). The special
control for this device is the FDA guidance document entitled ``Class
II Special Controls Guidance Document: Apnea Monitors; Guidance for
Industry and FDA.''
Dated: July 5, 2002.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-17957 Filed 7-16-02; 8:45 am]
BILLING CODE 4160-01-S