[Federal Register Volume 67, Number 137 (Wednesday, July 17, 2002)]
[Rules and Regulations]
[Pages 46851-46852]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-17957]


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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.

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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