[Federal Register Volume 72, Number 138 (Thursday, July 19, 2007)]
[Notices]
[Pages 39631-39632]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-14012]


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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Draft Guidance for Industry and Food and Drug Administration 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availability of the draft guidance entitled ``Pulse Oximeters--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 The draft guidance 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this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 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ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Pulse Oximeters--Premarket Notification 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    Submit written comments concerning this draft guidance to the 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 [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 (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