[Federal Register Volume 65, Number 43 (Friday, March 3, 2000)]
[Rules and Regulations]
[Pages 11464-11465]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-5160]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 868

[Docket No. 96P-0436]


Medical Devices; Anesthesiology Devices; Classification of Nitric 
Oxide Administration Apparatus, Nitric Oxide Analyzer, and Nitrogen 
Dioxide Analyzer

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the 
nitric oxide administration apparatus, nitric oxide analyzer, and 
nitrogen dioxide analyzer into class II (special controls). The special 
control that will apply to these devices is a guidance document. 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 amendments), the Safe Medical 
Devices Act of 1990, and the Food and Drug Administration Modernization 
Act of 1997. The agency is classifying these devices into class II 
(special controls) in order to provide a reasonable assurance of the 
safety and effectiveness of the devices.

DATES: This rule is effective April 3, 2000.

FOR FURTHER INFORMATION CONTACT: Joanna H. Weitershausen, Center for 
Devices and Radiological Health (HFZ-410), Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-
8609, ext. 164.

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 class 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.
    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 the issuance of an order classifying the 
device, FDA must publish a notice in the Federal Register announcing 
such classification.
    In accordance with section 513(f)(1) of the act, FDA issued an 
order on January 6, 2000, classifying the device 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 which was subsequently 
reclassified into class I or class II. On January 7, 2000, Datex-Ohmeda 
submitted a petition requesting classification of the nitric oxide 
administration apparatus, nitric oxide analyzer, and nitrogen dioxide 
analyzer under section 513(f)(2) of the act. This petition incorporated 
by reference a reclassification petition that Datex-Ohmeda had 
submitted previously. The manufacturer recommended that the device be 
classified into class II.
    After review of the information submitted in the original 
reclassification petition, the premarket notification submission 
(K974562), the panel recommendation of November 22, 1996, on the 
original reclassification petition, the automatic evaluation of class 
III designation petition, and the information developed by FDA to 
address concerns about delivery and monitoring of this drug, FDA 
determined that the INOvent Delivery System intended for use in 
administering nitric oxide, measuring nitric oxide, and measuring 
nitrogen dioxide can be classified in class II with

[[Page 11465]]

the establishment of special controls. FDA believes that class II 
special controls, in addition to the general controls, provide 
reasonable assurance of the safety and effectiveness of the device.
    The delivery system consists of three devices to which FDA assigns 
the generic names ``nitric oxide administration apparatus,'' ``nitric 
oxide analyzer,'' and ``nitrogen dioxide analyzer.'' The devices are 
identified as follows:
    1. Nitric oxide administration apparatus is a device used to add 
nitric oxide to gases that are to be breathed by a patient. The nitric 
oxide administration apparatus is to be used in conjunction with a 
ventilator or other breathing gas administration system.
    2. Nitric oxide analyzer is a device intended to measure the 
concentration of nitric oxide in respiratory gas mixtures during 
administration of nitric oxide.
    3. Nitrogen dioxide analyzer is a device intended to measure the 
concentration of nitrogen dioxide in respiratory gas mixtures during 
administration of nitric oxide.
    On January 11, 2000, FDA issued an order to the petitioner 
classifying the nitric oxide administration apparatus, nitric oxide 
analyzer, and nitrogen dioxide analyzer described previously into class 
II subject to the special controls described below. Additionally, FDA 
is codifying the classification of these devices by adding 
Secs. 868.2380, 868.2385, and 868.5165. In addition to the general 
controls of the act, the special control developed by the agency is a 
guidance document entitled ``Guidance Document for Premarket 
Notification Submissions for Nitric Oxide Administration Apparatus, 
Nitric Oxide Analyzer, and Nitrogen Dioxide Analyzer.'' This guidance 
document identifies the risks associated with these types of devices 
and contains information that will help manufacturers address those 
risks. This document is available on the Internet at http://www.fda.gov/cdrh/ode/1157.pdf.

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 impacts 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. 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 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.

IV. 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 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.

    2. Section 868.2380 is added to subpart C to read as follows:


Sec. 868.2380  Nitric oxide analyzer.

    (a) Identification. The nitric oxide analyzer is a device intended 
to measure the concentration of nitric oxide in respiratory gas 
mixtures during administration of nitric oxide.
    (b) Classification. Class II. The special control for this device 
is FDA's ``Guidance Document for Premarket Notification Submissions for 
Nitric Oxide Administration Apparatus, Nitric Oxide Analyzer, and 
Nitrogen Dioxide Analyzer.''

    3. Section 868.2385 is added to subpart C to read as follows:


Sec. 868.2385  Nitrogen dioxide analyzer.

    (a) Identification. The nitrogen dioxide analyzer is a device 
intended to measure the concentration of nitrogen dioxide in 
respiratory gas mixtures during administration of nitric oxide.
    (b) Classification. Class II. The special control for this device 
is FDA's ``Guidance Document for Premarket Notification Submissions for 
Nitric Oxide Administration Apparatus, Nitric Oxide Analyzer, and 
Nitrogen Dioxide Analyzer.''

    4. Section 868.5165 is added to subpart F to read as follows:


Sec. 868.5165  Nitric oxide administration apparatus.

    (a) Identification. The nitric oxide administration apparatus is a 
device used to add nitric oxide to gases that are to be breathed by a 
patient. The nitric oxide administration apparatus is to be used in 
conjunction with a ventilator or other breathing gas administration 
system.
    (b) Classification. Class II. The special control for this device 
is FDA's ``Guidance Document for Premarket Notification Submissions for 
Nitric Oxide Administration Apparatus, Nitric Oxide Analyzer, and 
Nitrogen Dioxide Analyzer.''

    Dated: February 24, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-5160 Filed 3-2-00; 8:45 am]
BILLING CODE 4160-01-F