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[Federal Register Volume 90, Number 4 (Tuesday, January 7, 2025)]
[Notices]
[Pages 1150-1152]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31540]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-4976]

Pulse Oximeters for Medical Purposes--Non-Clinical and Clinical 
Performance Testing, Labeling, and Premarket Submission 
Recommendations; Draft Guidance for Industry and Food and Drug 
Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the draft guidance entitled ``Pulse Oximeters for 
Medical Purposes--Non-Clinical and Clinical Performance Testing, 
Labeling, and Premarket Submission Recommendations.'' This draft 
guidance document, when finalized, will provide recommendations 
regarding non-clinical and clinical performance testing of certain 
pulse oximeters for medical purposes, including devices with a pulse 
oximeter function that estimates the amount of oxygen in arterial blood 
and pulse rate. These recommendations are being proposed based in part 
on concerns that the accuracy of pulse oximeters can be affected by, 
among other factors, a person's skin pigmentation. The recommendations 
are being proposed to inform the performance evaluation for these 
devices, to support premarket submissions, regardless of submission 
type, and to promote consistency and facilitate efficient review of 
these submissions. Among other topics, the draft guidance also proposes 
recommendations for labeling, which are intended to promote the safe 
and effective use of pulse oximeters and help users understand the 
benefits and risks associated with the use of the device. This draft 
guidance is not final nor is it for implementation at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by March 10, 2025 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2023-N-4976 for ``Pulse Oximeters for Medical Purposes--Non-
Clinical and Clinical Performance Testing, Labeling, and Premarket 
Submission Recommendations.'' Received comments will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    An electronic copy of the guidance document is available for 
download from the internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the draft guidance document entitled 
``Pulse Oximeters for Medical Purposes--Non-Clinical and Clinical 
Performance Testing, Labeling, and Premarket Submission 
Recommendations'' to the Office of Policy, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5441, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your 
request.

FOR FURTHER INFORMATION CONTACT: Kumudhini Hendrix, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire

[[Page 1151]]

Ave., Bldg. 66, Rm. 1259, Silver Spring, MD 20993-0002, 240-402-5262.

SUPPLEMENTARY INFORMATION:

I. Background

    This draft guidance document proposes recommendations regarding 
non-clinical and clinical performance testing of certain pulse 
oximeters for medical purposes, including devices with a pulse oximeter 
function that estimates the amount of oxygen in arterial blood and 
pulse rate. Pulse oximeters are widely used by many types of healthcare 
providers and lay-users to obtain an indirect measure of arterial blood 
oxygen saturation. These recommendations are being proposed based in 
part on concerns that the accuracy of pulse oximeters can be affected 
by, among other factors, a person's skin pigmentation. The 
recommendations are being proposed to inform the performance evaluation 
for these devices, to support premarket submissions, regardless of 
submission type, and to promote consistency and facilitate efficient 
review of these submissions. Among other topics, the draft guidance 
also proposes recommendations for labeling that are intended to promote 
the safe and effective use of pulse oximeters and help users understand 
the benefits and risks associated with the use of the device.
    In recent years, FDA has engaged interested parties regarding how 
the Agency can help to ensure patients have access to high-quality, 
safe, and effective pulse oximeters intended for medical purposes. 
Current scientific evidence from laboratory desaturation studies 
suggests that there are accuracy differences in some pulse oximeters, 
especially in lower arterial blood oxygen saturations, between lightly 
and darkly pigmented individuals. On November 1, 2022, FDA convened the 
Anesthesiology and Respiratory Therapy Devices Panel (2022 Panel) of 
the Medical Devices Advisory Committee. The 2022 Panel indicated that 
clinical evidence for prescription pulse oximeters showed disparate 
performance in patients with dark skin pigmentation (as compared to 
patients with light skin pigmentation), which causes increased risk for 
the patient for their given disease outcome. The 2022 Panel also 
indicated that factors other than skin pigmentation, including but not 
limited to low perfusion, explain some of the disparate performance. 
The 2022 Panel recommended standardization of skin pigmentation 
assessment and that overall, pulse oximeters for clinical use should be 
more accurate. In a discussion paper issued on November 16, 2023, FDA 
requested public comment on a series of questions related to an 
approach to improve the quality of premarket studies and associated 
methods used to evaluate the performance of pulse oximeters (Docket No. 
FDA-2023-N-4976), taking into consideration a participant's skin 
pigmentation and participant-reported race and ethnicity. On February 
2, 2024, FDA reconvened the Panel (``2024 Panel'') to discuss a 
proposed approach for these issues. The 2024 Panel was also asked to 
discuss the type and amount of data that should be provided by 
manufacturers to FDA to evaluate the performance of pulse oximeters 
submitted for premarket review, including prescription and over-the-
counter indications, and labeling considerations. After discussing the 
advantages and challenges, the 2024 Panel was in general agreement with 
the proposed approach. FDA considered comments from the discussion 
paper and Panel meetings and incorporated the feedback as appropriate 
in developing this draft guidance. FDA strongly encourages interested 
persons to submit comments regarding this topic, including any clinical 
studies or information that may be relevant for consideration.
    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 current thinking of FDA on ``Pulse 
Oximeters for Medical Purposes--Non-Clinical and Clinical Performance 
Testing, Labeling, and Premarket Submission Recommendations.'' It does 
not establish any rights for any person and is not binding on FDA or 
the public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.

II. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by downloading an electronic copy from the internet. A search 
capability for all Center for Devices and Radiological Health guidance 
documents is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also 
available at https://www.regulations.gov and at https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to 
download an electronic copy of ``Pulse Oximeters for Medical Purposes--
Non-Clinical and Clinical Performance Testing, Labeling, and Premarket 
Submission Recommendations'' may send an email request to [email protected] to receive an electronic copy of the document. 
Please use the document number GUI00001605 and complete title to 
identify the guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no new collection of information, it 
does refer to previously approved FDA collections of information. The 
previously approved collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information 
in the following table have been approved by OMB:

------------------------------------------------------------------------
                                                            OMB control
      21 CFR part or guidance               Topic               No.
------------------------------------------------------------------------
807, subpart E....................  Premarket                  0910-0120
                                     notification.
814, subparts A through E.........  Premarket approval..       0910-0231
812...............................  Investigational            0910-0078
                                     Device Exemption.
860, subpart D....................  De Novo                    0910-0844
                                     classification
                                     process.
``Requests for Feedback and         Q-submissions and          0910-0756
 Meetings for Medical Device         Early Payor
 Submissions: The Q-Submission       Feedback Request
 Program''.                          Programs for
                                     Medical Devices.
800, 801, 809, and 830............  Medical Device             0910-0485
                                     Labeling
                                     Regulations; Unique
                                     Device
                                     Identification.

[[Page 1152]]

 
820...............................  Current Good               0910-0073
                                     Manufacturing
                                     Practice (CGMP);
                                     Quality System (QS)
                                     Regulation.
50, 56............................  Protection of Human        0910-0130
                                     Subjects and
                                     Institutional
                                     Review Boards.
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    Dated: December 26, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-31540 Filed 1-6-25; 8:45 am]
BILLING CODE 4164-01-P
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