[Federal Register: July 19, 2007 (Volume 72, Number 138)]
[Notices]
[Page 39631-39632]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19jy07-51]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D-0252]
Draft Guidance for Industry and Food and Drug Administration
Staff; Pulse Oximeters--Premarket Notification Submissions [510(k)s];
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availability of the draft guidance entitled ``Pulse Oximeters--
Premarket Notification Submissions [510(k)s].'' The draft guidance
describes FDA's recommendations about the content of premarket
notification submissions (510(k)s) for pulse oximeter devices.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115 (g)(5)), to ensure that the agency considers your comment on
this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by October 17, 2007.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Pulse Oximeters--Premarket Notification
Submissions [510(k)s]'' 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 one self-addressed adhesive label to
assist that office in processing your request, or fax your request to
240-276-3151. See the SUPPLEMENTARY INFORMATION section for information
on electronic access to the guidance.
Submit written comments concerning this draft guidance to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, 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: Neel J. Patel, Center for Devices and
Radiological Health (HFZ-480), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 240-276-3700.
SUPPLEMENTARY INFORMATION:
I. Background
A pulse oximeter is a device intended for the non-invasive
measurement of arterial blood oxygen saturation and pulse rate. It is a
class II device in accordance with 21 CFR 870.2700. The draft guidance
describes FDA's recommendations about the accuracy, performance,
biocompatibility, safety, and labeling of pulse oximeters. In
particular, the draft guidance incorporates the recommendations of the
Anesthesiology and Respiratory Therapy Devices Panel (the Panel). At
the open public meeting held on May 13, 2005, the Panel made
recommendations regarding general issues for pulse oximeters, including
reflectance sensor technology and the clinical validation of accuracy
when the device is intended for neonatal use. FDA agreed and
incorporated these recommendations into the draft guidance.
(Transcripts of the May 13, 2005, meeting are available at http://www.fda.gov/ohrms/dockets/ac/05/transcripts/2005-4141T1.htm.
)
II. Significance of 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 ``Pulse
Oximeters--Premarket Notification Submissions [510(k)s].'' 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 requirements of the applicable statute and
regulations.
[[Page 39632]]
III. Electronic Access
Persons interested in obtaining a copy of the draft guidance may do
so by using the Internet. To receive ``Pulse Oximeters--Premarket
Notification Submissions [510(k)s],'' 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 (1605) 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 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 807, subpart E, have been
approved under OMB control number 0910-0120; and the collections of
information in 21 CFR part 801 have been approved under OMB control
number 0910-0485.
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. Received 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 Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
Dated: July 3, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E7-14012 Filed 7-18-07; 8:45 am]
BILLING CODE 4160-01-S