[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]
BILLING CODE 4160-01-P