[Federal Register Volume 65, Number 15 (Monday, January 24, 2000)]
[Notices]
[Pages 3723-3724]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-1535]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D-5297]


Medical Devices; Guidance Document for Premarket Notification 
Submissions for the Nitric Oxide Delivery Apparatus, Nitric Oxide 
Analyzer, and Nitrogen Dioxide Analyzer; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of a guidance document entitled ``Guidance Document for 
Premarket Notification Submissions for the Nitric Oxide Delivery 
Apparatus, Nitric Oxide Analyzer, and Nitrogen Dioxide Analyzer.'' This 
guidance will serve as a special control for nitric oxide delivery 
apparatus; nitric oxide analyzer; and nitrogen dioxide analyzer. FDA's 
Center for Devices and Radiological Health (CDRH) believes that this 
guidance is necessary to provide reasonable assurance of the safety and 
effectiveness of these devices. The guidance document includes material 
specific for the devices, consensus standards for electrical safety, 
electromagnetic compatibility, software and hardware documentation, and 
resistance to environmental effects.

DATES:  Written comments concerning this guidance document must be 
received by April 24, 2000.

ADDRESSES:  See the SUPPLEMENTARY INFORMATION section for information 
on electronic access to the guidance document. Submit written requests 
for single copies of the guidance document entitled ``Guidance Document 
for Premarket Notification Submissions for Nitric Oxide Delivery 
Apparatus, Nitric Oxide Analyzer, and Nitrogen Dioxide Analyzer'' to 
the Division of Small Manufacturers Assistance (HFZ-220), Center for 
Devices and Radiological Health, Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive 
labels to assist that office in processing your request, or fax your 
request to 301-443-8818. By April 24, 2000, written comments concerning 
this guidance document must be submitted to the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852. Comments should be identified with the 
docket number found in brackets in the heading of this document. After 
April 24, 2000, comments must be submitted to the contact person 
identified below.

FOR FURTHER INFORMATION CONTACT:  Michael G. Bazaral, Center for 
Devices and Radiological Health (HFZ-450), Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-
8609.

SUPPLEMENTARY INFORMATION:

I. Background

    On January 11, 2000, FDA issued an order to Datex-Ohmeda, Inc., 
under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act 
(the act) (21 U.S.C. 360c(f)(2)) classifying the nitric oxide 
administration apparatus, the nitric oxide gas analyzer, and the nitric 
dioxide analyzer into class II (special controls). This guidance 
document is intended to serve as the special control for these devices.
    FDA is making this guidance document effective immediately

[[Page 3724]]

because these devices are necessary for the administration of a drug 
that provides a significant public health benefit. The drug, which was 
approved by FDA on December 23, 1999, is used for the treatment of 
neonates with hypoxic respiratory failure associated with clinical or 
echocardiographic evidence of pulmonary hypertension. The drug improves 
oxygenation and reduces the need for extracorporeal membrane 
oxygenation.
    The guidance document is intended to set forth the controls and 
testing that FDA believes ensure the safety and effectiveness of the 
nitric oxide administration apparatus, nitric oxide gas analyzer, and 
nitrogen dioxide gas analyzer. It also intends to provide comprehensive 
directions to enable a manufacturer to submit a 510(k) premarket 
notification demonstrating substantial equivalence for any or all three 
device types.
    The guidance document identifies the risks associated with these 
types of devices and contains information that will help manufacturers 
address those risks. The guidance outlines the controls that should be 
incorporated in the devices for controlling risks, testing that should 
be completed for each device, and suggested methods for developing 
preclinical criteria. Other elements of the guidance document include: 
(1) General device description; (2) specific description of the 
information to support applications for each device; and (3) general 
considerations for each device, such as software and hardware testing.

II. Significance of Guidance

    This guidance document represents the agency's current thinking on 
the premarket notification submissions for the nitric oxide delivery 
apparatus, nitric oxide analyzer, and nitrogen dioxide analyzer. It 
does not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. An alternative approach may be used 
if such approach satisfies the applicable statute, regulations, or 
both.
    The agency has adopted good guidance practices (GGP's), which set 
forth the agency's policies and procedures for the development, 
issuance, and use of guidance documents (62 FR 8961, February 27, 
1997). This guidance document is issued as a Level 1 guidance 
consistent with GGP's.

III. Electronic Access

    In order to receive the ``Guidance Document for Premarket 
Notification Submissions for Nitric Oxide Delivery Apparatus, Nitric 
Oxide Analyzer, and Nitrogen Dioxide Analyzer'' via your fax machine, 
call the CDRH Facts-On-Demand (FOD) system at 800-899-0381 or 301-827-
0111 from a touch-tone telephone. At the first voice prompt press 1 to 
access DSMA Facts, at second voice prompt press 2, and then enter the 
document number (1157) followed by the pound sign (#). Then follow the 
remaining voice prompts to complete your request.
    Persons interested in obtaining a copy of the guidance document 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 access to the Internet. 
Updated on a regular basis, the CDRH home page includes the ``Guidance 
Document for Premarket Notification Submissions for Nitric Oxide 
Delivery Apparatus, Nitric Oxide Analyzer, and Nitrogen Dioxide 
Analyzer,'' 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. The ``Guidance Document for Premarket Notification Submissions 
for Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer, and 
Nitrogen Dioxide Analyzer'' will be available at http://www.fda.gov/cdrh/ggpmain.html.

IV. Comments

    Interested persons may, on or before April 24, 2000, submit to the 
Dockets Management Branch (address above) written comments regarding 
this immediately in effect guidance document. 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.

    Dated: January 13, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-1535 Filed 1-21-00; 8:45 am]
BILLING CODE 4160-01-F