[Federal Register Volume 68, Number 129 (Monday, July 7, 2003)]
[Rules and Regulations]
[Pages 40125-40127]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-16953]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 862

[Docket No. 2003D-0209]


Medical Devices; Clinical Chemistry and Clinical Toxicology 
Devices; Classification of the Breath Nitric Oxide Test System

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the 
breath nitric oxide test system into class II (special controls). The 
agency is taking this action in response to a petition submitted under 
the Federal Food, Drug, and Cosmetic Act (the act) as amended by the 
Medical Device Amendments of 1976 (the 1976 amendments), the Safe 
Medical Devices Act of 1990 (the SMDA), and the Food and Drug 
Administration Modernization Act of 1997 (FDAMA). The agency is 
classifying this device into class II (special controls) in order to 
provide a reasonable assurance of safety and effectiveness of the 
device. Elsewhere in this issue of the Federal Register, FDA is 
announcing the availability of a guidance document that will serve as 
the special control for the device.

DATES: This rule is effective August 6, 2003.

FOR FURTHER INFORMATION CONTACT: Jean Cooper, Center for Devices and 
Radiological Health (HFZ-440), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, 301-594-1243.

SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of the act (21 U.S.C. 
360c(f)(1)), devices that were not in commercial distribution before 
May 28, 1976, the date of enactment of the amendments, generally 
referred to as postamendments devices, are classified automatically by 
statute into class III without any FDA rulemaking process. These 
devices remain in class III and require premarket approval, unless and 
until the device is classified or reclassified into class I or II, or 
FDA issues an order finding the device to be substantially equivalent, 
in accordance with section 513(i) of the act, to a predicate device 
that does not require premarket approval. The agency determines whether 
new devices are substantially equivalent to previously marketed devices 
by means of premarket notification procedures in section 510(k) of the 
act (21 U.S.C. 360(k)) and 21 CFR part 807 of the FDA regulations.
    Section 513(f)(2) of the act provides that any person who submits a 
premarket notification under section 510(k) of the act for a device 
that has not previously been classified may, within 30 days after 
receiving an order classifying the device in class III under section 
513(f)(1) of the act, request FDA to classify the device under the 
criteria set forth in section 513(a)(1) of the act. FDA shall, within 
60 days of receiving such a request, classify the device by written 
order. This classification shall be the initial classification of the 
device. Within 30 days after issuing an order classifying the device, 
FDA must publish a notice in the Federal Register announcing the 
classification.
    On March 17, 2003, FDA received a petition submitted under section 
513(f)(2) of the act by Aerocrine AB, through Certified Software 
Solutions, Inc., seeking an evaluation of the automatic class III 
designation of its NIOX BREATH NITRIC OXIDE TEST SYSTEM. In accordance 
with section 513(f)(1) of the act, FDA issued an order automatically 
classifying the NIOX BREATH NITRIC OXIDE TEST SYSTEM in class III 
because it was not substantially equivalent to a device that was 
introduced or delivered for introduction into interstate commerce for 
commercial distribution before May 28, 1976, or a device that was 
subsequently reclassified into class I or II. After reviewing 
information submitted in the petition, FDA determined that the NIOX 
BREATH NITRIC OXIDE TEST SYSTEM can be classified in class II with the 
establishment of special controls. This device is intended to aid in 
evaluating an asthma patient's response to anti-inflammatory therapy by 
measuring changes in fractional exhaled nitric oxide concentration in 
asthma patients, as an adjunct to established clinical and laboratory 
assessments of asthma. FDA believes that class II special controls, in 
addition to the general controls, will provide reasonable assurance of 
the safety and effectiveness of the device.
    FDA has identified the risk to health associated specifically with 
this type of device as improper patient management. Therefore, in 
addition to the general controls of the act, the device is subject to a 
special controls guidance document entitled ``Class II Special Controls 
Guidance Document: Breath Nitric Oxide Test System.''
    The class II special controls guidance provides information on how 
to meet

[[Page 40126]]

premarket (510(k)) submission requirements for the device, including 
recommendations for labeling and performance studies. FDA believes that 
adherence to the class II special controls addresses the potential risk 
to health identified in the previous paragraph and provides a 
reasonable assurance of the safety and effectiveness of the device.
    Following the effective date of this final classification rule, any 
firm submitting a 510(k) premarket notification for a breath nitric 
oxide test system will need to address the issues covered in the 
special controls guidance document. 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.
    Section 510(m) of the act provides that FDA may exempt a class II 
device from the premarket notification requirement under section 510(k) 
of the act, if FDA determines that premarket notification is not 
necessary to provide reasonable assurance of the safety and 
effectiveness of the device. For this type of device, FDA has 
determined that premarket notification is necessary to provide 
reasonable assurance of safety and effectiveness and, therefore, the 
device is not exempt from the premarket notification requirements. The 
device is used as an aid in evaluating an asthma patient's response to 
anti-inflammatory therapy by measuring changes in fractional exhaled 
nitric oxide concentration in asthma patients, as an adjunct to 
established clinical and laboratory assessments of asthma. FDA review 
of performance characteristics and labeling will ensure that acceptable 
levels of performance for both safety and effectiveness are addressed 
before marketing clearance. Thus, persons who intend to market this 
device must submit to FDA a premarket notification submission 
containing information on the breath nitric oxide test system before 
marketing the device.
    On April 30, 2003, FDA issued an order classifying the NIOX BREATH 
NITRIC OXIDE TEST SYSTEM and substantially equivalent devices of this 
generic type into class II under the generic name, breath nitric oxide 
test system. FDA identifies this generic type of device as a breath 
nitric oxide test system, which is intended to aid in evaluating an 
asthma patient's response to anti-inflammatory therapy by measuring 
changes in fractional exhaled nitric oxide concentration in asthma 
patients, as an adjunct to established clinical and laboratory 
assessments of asthma.
    FDA is codifying this device by adding Sec.  862.3080. The order 
also identifies a special control applicable to this device, a guidance 
document entitled ``Class II Special Controls Guidance Document: Breath 
Nitric Oxide Test System.''

II. Electronic Access

    In order to receive the guidance entitled ``Class II Special 
Controls Guidance Document: Breath Nitric Oxide Test System'' via your 
fax machine, call the CDRH Facts-on-Demand system at 800-899-0381 or 
301-827-0111 from a touch-tone telephone. At the first voice prompt, 
press 1 to enter the system. At the second voice prompt, press 1 to 
order a document. Enter the document number (1211) followed by the 
pound sign ([numsign]). Follow the remaining voice prompts to complete 
your request.
    Persons interested in obtaining a copy of the guidance may also do 
so using the Internet. CDRH maintains an entry on the Internet for easy 
access to information including text, graphics, and files that may be 
downloaded to a personal computer with Internet access. Updated on a 
regular basis, the CDRH home page includes the civil money penalty 
guidance documents package, device safety alerts, Federal Register 
reprints, information on premarket submissions (including lists of 
approved applications and manufacturers' addresses), small 
manufacturers' assistance, information on video conferencing and 
electronic submissions, Mammography Matters, and other device-oriented 
information. The CDRH home page may be accessed at http://www.fda.gov/cdrh.

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 final rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), 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 it 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. FDA knows of only one manufacturer of this type of 
device. Classification of these devices from class III to class II will 
relieve manufacturers of the device of the cost of complying with the 
premarket approval requirements of section 515 of the act (21 U.S.C. 
360e), and may permit small potential competitors to enter the 
marketplace by lowering their costs. The agency, therefore, certifies 
that the final rule will not have a significant impact on a substantial 
number of small entities. In addition, this final 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 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 Executive order and, consequently, a 
federalism summary impact statement is not required.

VI. Paperwork Reduction Act of 1995

    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 862

    Medical devices.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
862 is amended as follows:

[[Page 40127]]

PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

    1. The authority citation for 21 CFR part 862 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. Section 862.3080 is added to subpart D to read as follows:


Sec.  862.3080  Breath nitric oxide test system.

    (a) Identification. A breath nitric oxide test system is a device 
intended to measure fractional nitric oxide in human breath. 
Measurement of changes in fractional nitric oxide concentration in 
expired breath aids in evaluating an asthma patient's response to anti-
inflammatory therapy, as an adjunct to established clinical and 
laboratory assessments of asthma. A breath nitric oxide test system 
combines chemiluminescence detection of nitric oxide with a 
pneumotachograph, display, and dedicated software.
    (b) Classification. Class II (special controls). The special 
control is FDA's guidance entitled ``Class II Special Controls Guidance 
Document: Breath Nitric Oxide Test System.'' See Sec.  862.1(d) for the 
availability of this guidance document.

    Dated: June 23, 2003.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 03-16953 Filed 7-3-03; 8:45 am]
BILLING CODE 4160-01-S