[Federal Register Volume 72, Number 38 (Tuesday, February 27, 2007)]
[Notices]
[Pages 8757-8758]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-3254]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007D-0020]


Draft Guidance for Industry and Food and Drug Administration 
Staff; Class II Special Controls Guidance Document; Oxygen Pressure 
Regulators and Oxygen Conserving Devices; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry and FDA staff entitled 
``Class II Special Controls Guidance Document: Oxygen Pressure 
Regulators and Oxygen Conserving Devices.'' The draft guidance document 
is intended to assist manufacturers in complying with minimum 
performance, testing, and labeling recommendations that are being 
proposed for these devices. Elsewhere in this issue of the Federal 
Register, FDA is publishing a proposed rule to reclassify pressure 
regulators for use with medical oxygen into class II, subject to 
special controls. The proposal would also establish separate 
identification classifications for both oxygen pressure regulators and 
oxygen conserving devices, and would make those oxygen conserving 
devices that incorporate a built-in oxygen pressure regulator subject 
to special controls. This draft guidance is not final nor is it in 
effect at this time.

DATES: Submit written or electronic comments on the draft guidance by 
May 29, 2007.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Class II Special Controls Guidance 
Document: Oxygen Pressure Regulators and Oxygen Conserving Devices'' to 
the Division of Small Manufacturers, International, and Consumer 
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 1-800-638-2041. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the draft 
guidance document. Submit written comments on the draft guidance to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 101, Rockville, MD 20852. Submit electronic 
comments to http://www.fda.gov/dockets/ecomments. Identify comments 
with the docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: Christy Foreman, Center for Devices 
and Radiological Health (HFZ-340), Food and Drug Administration, 2094 
Gaither Rd., Rockville, MD 20850, 240-276-0120.

SUPPLEMENTARY INFORMATION:

I. Background

    This draft guidance provides FDA's recommendations to manufacturers 
for labeling and for determining ignition sensitivity and fault 
tolerance for oxygen pressure regulators. These devices are intended to 
convert medical oxygen pressure from a high variable pressure to a 
lower, more constant working pressure. The device is affixed to a 
pressurized container of oxygen and the regulator controls the gas 
flow. These devices are currently regulated as class I devices. 
However, FDA has received reports of fires and explosions associated 
with the use of oxygen pressure regulators resulting in serious injury 
to a number of equipment operators, including one fatality. The draft 
guidance, if finalized, would serve as the special control for these 
devices. FDA believes that conformance with the draft special controls 
guidance, when combined with the general controls of the Federal Food, 
Drug, and Cosmetic Act (the act), would address the risks associated 
with oxygen pressure regulators and provide reasonable assurance of 
their safety and effectiveness.
    The draft guidance would also serve as a special control for oxygen 
conserving devices with a built-in oxygen pressure regulator; a device 
type already classified into class II under the generic device type 
noncontinuous ventilator (21 CFR 868.5905). FDA believes that 
conformance with the draft special controls guidance, when combined 
with the general controls of the act, will provide reasonable assurance 
of the safety and effectiveness of oxygen conserving devices with a 
built-in oxygen pressure regulator.
    In the Federal Register of May 27, 2003 (68 FR 30214), FDA 
announced its intention to reclassify oxygen pressure regulators in its 
semi-annual regulatory agenda. FDA received one comment supporting the 
establishment of a proposed rule to reclassify these devices.

[[Page 8758]]

II. Significance of the Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on oxygen 
pressure regulators and oxygen conserving devices with a built-in 
oxygen pressure regulator. It does not create or confer any rights for 
or on any person and would not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
requirements of the applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by using the Internet. To receive ``Class II Special Controls 
Guidance Document: Pressure Regulators For Use With Medical Oxygen and 
Oxygen Conserving Devices,'' you may either send an e-mail request to 
[email protected] to receive an electronic copy of the document, or 
send a fax request to 240-276-3151 to receive a hard copy. Please use 
the document number 1227 to identify the guidance you are requesting.
    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 device safety alerts, Federal 
Register reprints, information on premarket submissions (including 
lists of approved applications and manufacturers' addresses), small 
manufacturer's assistance, information on video conferencing and 
electronic submissions, Mammography Matters, and other device-oriented 
information. The CDRH Web site may be accessed at http://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available 
at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also 
available on the Division of Dockets Management Internet site at http://www.fda.gov/ohrms/dockets.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-
3520). The collections of information in 21 CFR part 807, subpart E 
(premarket notification procedures) have been approved under OMB 
Control number 0910-0120. The labeling statements that would be 
required by this regulation are ``public disclosure[s] of information 
originally supplied by the Federal government to the recipient for the 
purpose of disclosure to the public * * *'' (5 CFR 1320.3(c)(2)). 
Accordingly, FDA concludes that the labeling requirements in this 
proposed rule are not subject to review by OMB under the PRA.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES), written or electronic comments regarding this 
document. Submit a single copy of electronic comments or two paper 
copies of any mailed comments, except that individuals may submit one 
paper copy. Comments are to be identified with the docket number found 
in brackets in the heading of this document. The draft guidance and 
received comments may be seen in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: February 8, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E7-3254 Filed 2-26-07; 8:45 am]
BILLING CODE 4160-01-S