[Federal Register: February 27, 2007 (Volume 72, Number 38)]
[Notices]
[Page 8757-8758]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27fe07-96]
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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Draft Guidance for Industry and Food and Drug Administration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.
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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availability of a draft guidance for industry and FDA staff entitled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 The draft guidance document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 This draft guidance is not final nor is it in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DATES: Submit written or electronic comments on the draft guidance by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ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Class II Special Controls Guidance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SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document. Submit written comments on the draft guidance to the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
dsmica@fda.hhs.gov 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