[Federal Register Volume 65, Number 185 (Friday, September 22, 2000)]
[Proposed Rules]
[Pages 57301-57303]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-24334]


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

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: Proposed rule.

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

SUMMARY: The Food and Drug Administration (FDA) is publishing a 
proposed 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. Elsewhere in this 
issue of the Federal Register, FDA is withdrawing a proposed mandatory 
standard for infant apnea monitors and is announcing the availability 
of a draft guidance document that will serve as the special control.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: Submit written comments by December 21, 2000.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Joanna H. Weitershausen, 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 10, 1982 (47 FR 39816), FDA 
classified devices intended to measure or monitor a patient's 
respiratory rate into class II (performance standards) as part of the 
generic group of devices known as breathing (ventilatory) frequency 
monitors (Sec. 868.2375 (21 CFR 868.2375)). Under the classification 
scheme set forth in section 513 of the Federal Food, Drug, and Cosmetic 
Act (the act) (21 U.S.C. 360c), as amended by the Medical Device 
Amendments of 1976 (the 1976 amendments) (Public Law 94-295), the 
agency determined that performance standards were necessary to provide 
reasonable assurance of the safety and effectiveness of these devices.
    After several initial steps, described in the notice published 
elsewhere in this issue of the Federal Register announcing the 
withdrawal of the proposed rule to establish a performance standard for 
the infant apnea monitor (withdrawal), FDA issued a proposed rule 
setting forth requirements for a performance standard for the infant 
apnea monitor (60 FR 9762, February 21, 1995). For the reasons 
discussed in the withdrawal, FDA determined that it is not necessary to 
establish a mandatory performance standard for the device.
    In its place, FDA has developed a draft industry guidance document 
setting forth the agency's current position regarding minimum 
performance characteristics, test procedures and criteria, labeling, 
and, as appropriate, clinical testing for certain apnea monitors, i.e., 
the infant/child apnea monitor. The current draft guidance identifies 
the monitor used on this population because infants and children under 
3 years old are particularly subject to the pathophysiological 
consequences of prolonged apneas lasting over 20 seconds in duration. 
The current draft guidance includes basic concepts set out in the 
proposed standard for the infant apnea monitor, but updates, 
consolidates, or eliminates certain

[[Page 57302]]

elements of the proposed standard on the basis of comments received on 
the proposal and the continuing development and FDA's recognition of 
appropriate consensus standards.
    FDA is announcing the public availability of this draft guidance 
document in a notice published elsewhere in this issue of the Federal 
Register. Though the draft guidance currently represents the agency's 
position with regard to the infant/child apnea monitor, the agency 
believes the performance, testing, labeling, and, as appropriate, 
clinical criteria in the guidance are applicable as well to the apnea 
monitor used on patients of other ages. In the Federal Register notice 
announcing the public availability of this draft guidance, the agency 
invites comment on these specific issues.
    FDA intends to modify the current guidance in the next draft, 
including the development of minimum clinical study parameters, so that 
it represents the agency's current thinking with regard to the apnea 
monitor used on any age group. The final industry guidance document 
will describe the minimum performance, testing, labeling, and clinical 
testing criteria that the agency believes will provide, in conjunction 
with the general controls of the act, reasonable assurance of the 
safety and effectiveness of the apnea monitor.

II. Proposed Rule

    In this rule, FDA is proposing to revise current Sec. 868.2375(a) 
to state that the section does not apply to the apnea monitor. This 
proposed change is stated in the last sentence.
    To identify operational parameters in conformance with technology, 
FDA proposes revising the second sentence of Sec. 868.2375(a) from 
``when the respiratory rate is outside predetermined limits'' to ``when 
the respiratory rate, averaged over time, is outside operator settable 
limits.'' Including ``averaged over time'' distinguishes the 
differences between a breathing frequency monitor and an apnea monitor. 
The breathing frequency monitor averages the breath rate over a given 
time (i.e., 30 seconds, 1 minute) and, then, alarms at the settings the 
operator has made. The limits are set by the operator and, therefore, 
are not predetermined. In contrast, the apnea monitor alarms when the 
next breath is not detected in a set time.
    FDA also proposes adding Sec. 868.2377 to classify the apnea 
monitor in class II and designate the guidance document entitled 
``Guidance for Apnea Monitor 510(k) Submissions'' as a special control 
for the device. The apnea monitor identified in proposed 
Sec. 868.2377(a) includes, but is not limited to, the infant/child 
apnea monitor intended for use on infants under 1 year old and children 
under 3 years old.
    FDA will issue the final guidance document identified as the 
special control in proposed Sec. 868.2377(b) upon considering comments 
received on the draft guidance currently entitled ``Guidance for 
Infant/Child Apnea Monitor 510(k) Submissions.'' As noted above, FDA 
believes the recommendations it makes in this guidance regarding apnea 
monitors used for infants and children are applicable as well to apnea 
monitors used for patients in other age groups. Thus, FDA will modify 
the final guidance document so that it represents the agency's current 
thinking regarding the performance characteristics, test procedures and 
criteria, labeling recommendations, and clinical study parameters that 
are needed, in conjunction with general controls, to reasonably assure 
the safety and effectiveness of the apnea monitor.

III. 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.

IV. Analysis of Impacts

    FDA has examined the impacts of the proposed 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 proposed rule is consistent 
with the regulatory philosophy and principles identified in the 
Executive Order. This proposal to classify the apnea monitor in class 
II as a type of device that is separate from the breathing frequency 
monitor, and subject to the special control of industry guidance issued 
by FDA, will not require any firm that currently is legally 
distributing an apnea monitor to comply with guidance recommendations 
issued by FDA for the devices. Subsequent to FDA issuance of the final 
classification rule and the final industry guidance document, a firm 
submitting a 510(k) premarket notification for a ``new'' apnea monitor 
will need to address guidance recommendations. However, the firm need 
only show that its device is as safe and effective as a device that 
meets guidance recommendations. The firm may use alternative approaches 
if those approaches meet the performance, testing, labeling, and 
clinical study parameters described in the guidance.
    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. In addition, in November 1993, the agency issued a guidance 
document,\1\ made available to industry, which described evaluation 
criteria used by reviewers in FDA's Center for Devices and Radiological 
Health to review 510(k) submissions for apnea monitors. Many criteria 
in the November 1993 document correspond to performance, testing, and 
labeling recommendations in the draft industry guidance for infant/
child apnea monitors. The latter guidance, as noted previously, will be 
modified and become the special control guidance referenced in this 
apnea monitor classification proposal.
---------------------------------------------------------------------------

    \1\ ``Reviewer Guidance for Premarket Notification Submissions 
November 1993, Anesthesiology and Respiratory Devices Branch, 
Division of Cardiovascular, Respiratory, and Neurological Devices.''
---------------------------------------------------------------------------

    Based on the above, FDA believes that, on average, no more than two 
510(k)'s per year will be submitted for ``new'' apnea monitors by firms 
that must address performance, testing, and labeling parameters 
recommended in the special control guidance document issued by the 
agency as final guidance after considering comments on the draft 
guidance. The agency believes that the final guidance document 
constituting the special control will not set out performance, testing, 
or labeling criteria of a type not previously recommended for apnea 
monitor devices. FDA also believes that, under normal business 
practices in response to competitive market forces over the past 10 
years, the manufacturer of an apnea monitor will have in place designs 
and procedures that meet any updated

[[Page 57303]]

recommendations in FDA's final guidance document.
    Because of the above factors, FDA believes apnea monitor 
manufacturers will incur no costs other than those associated with the 
submission of 510(k) premarket notifications for ``new'' monitors. FDA 
has estimated this cost to be $6,000 per submission on the basis that 
it takes device firms approximately 80 hours to complete a 510(k) 
package (exclusive of preparing clinical data, research, etc.) and 
costs an average of $75.00 per hour to perform this type of work. Thus, 
FDA estimates the cost to industry of this classification proposal to 
be approximately $12,000 per year ($6,000 per 510(k) submission x 2 
submissions per year). Therefore, the agency certifies that this 
proposal, if finalized, will not have a significant economic impact on 
a substantial number of small businesses.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 (Public 
Law 104-4) requires that agencies prepare a written statement of 
anticipated costs and benefits before proposing any rule that may 
result in an expenditure by State, local, and tribal governments, in 
the aggregate, or by the private sector, of $100 million in any one 
year (adjusted annually for inflation). The Unfunded Mandates Reform 
Act of 1995 does not require FDA to prepare a statement of costs and 
benefits for the proposed rule, because the proposed rule is not 
expected to result in any 1-year expenditure that would exceed $100 
million adjusted for inflation.

V. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
burden hours required for proposed Sec. 868.2377 are reported and 
approved under OMB Control No. 0910-0120.

VI. Federalism

    FDA has analyzed this proposed 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.

VII. Submission of Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments regarding this proposal by December 
21, 2000. Two copies of any comments are to be submitted, except that 
individuals may submit one copy. Comments are to be identified with the 
docket number found in brackets in the heading of this document. 
Received comments may be seen in the Dockets Management Branch between 
9 a.m. and 4 p.m., Monday through Friday.

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, it is 
proposed that 21 CFR part 868 be 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 868.2375(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 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 includes a secondary modality, such 
as heart rate monitoring, that will alarm in response to the 
physiological consequences of apnea.
    (b) Classification. Class II (special controls) (Guidance document: 
``Guidance for Apnea Monitor 510(k) Submissions'').

    Dated: September 1, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-24334 Filed 9-21-00; 8:45 am]
BILLING CODE 4160-01-F