[Federal Register Volume 78, Number 42 (Monday, March 4, 2013)]
[Notices]
[Page 14097]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-04870]



[[Page 14097]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0205 (Formerly 2007D-0252)]


Pulse Oximeters--Premarket Notification Submissions [510(k)s]; 
Guidance for Industry and Food and Drug Administration Staff; 
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 guidance entitled ``Pulse Oximeters--Premarket 
Notification Submissions [510(k)s].'' This guidance document pertains 
to non-invasive pulse oximeters intended for prescription use to 
measure arterial blood oxygen saturation (SpO2) and pulse 
rate. This document supersedes the General Guidance Document entitled 
``Device: Non-Invasive Pulse Oximeter'' issued on September 7, 1992, 
and represents the Agency's current thinking in regards to information 
that should be included in a premarket submission for a non-invasive 
pulse oximeter.

DATES: Submit either electronic or written comments on this guidance at 
any time. General comments on Agency guidance documents are welcome at 
any time.

ADDRESSES: Submit written requests for single copies of the guidance 
document entitled ``Pulse Oximeters--Premarket Notification Submissions 
[510(k)s]'' to the Division of Small Manufacturers, International and 
Consumer Assistance, Center for Devices and Radiological Health, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, 
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to 
assist that office in processing your request, or fax your request to 
301-847-8149. See the SUPPLEMENTARY INFORMATION section for information 
on electronic access to the guidance.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Neel Patel, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2532, Silver Spring, MD 20993-0002, 301-796-6274.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA has developed this guidance document to assist industry in 
preparing a Premarket Notification (510(k)) for a pulse oximeter. The 
device is intended for non-invasive measurement of SpO2 and 
pulse rate. In the Federal Register of July 19, 2007 (72 FR 39631), FDA 
announced the availability of the draft guidance document. Interested 
persons were invited to comment by October 17, 2007. Two sets of 
comments were received with recommendations related to organization, 
terminology, references to standards, labeling, test recommendations, 
and data analysis. In response, FDA revised the guidance document to 
address the comments and clarify our recommendations as appropriate. 
This document supersedes the guidance document ``Non-Invasive Pulse 
Oximeter General Guidance Document,'' dated September 7, 1992.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on non-invasive pulse oximeters intended for 
prescription use to measure SpO2 and pulse rate. 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.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
using the Internet. A search capability for all CDRH guidance documents 
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov. To receive 
``Pulse Oximeters--Premarket Notification Submissions [510(k)s],'' you 
may either send an email request to [email protected] to receive an 
electronic copy of the document or send a fax request to 301-847-8149 
to receive a hard copy. Please use the document number 1605 to identify 
the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This 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; the collections of information in 21 CFR part 812 
have been approved under OMB control number 0910-0078; the collections 
of information in 21 CFR 56.115 have been approved under OMB control 
number 0910-0130.

V. Comments

    Interested persons may submit either written comments regarding 
this document to the Division of Dockets Management (see ADDRESSES) or 
electronic comments to http://www.regulations.gov. It is only necessary 
to send one set of comments. Identify comments 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, and will be posted to the docket at http://www.regulations.gov.

    Dated: February 26, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-04870 Filed 3-1-13; 8:45 am]
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