[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Recommendations; Draft Guidance for Industry and Food and Drug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the availability of the draft guidance entitled ``Pulse Oximeters for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 This draft
guidance document, when finalized, will provide recommendations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 Among other topics, the draft guidance also proposes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 This draft
guidance is not final nor is it for implementation at this time.
DATES: Submit either electronic or written comments on the draft
guidance by March 10, 2025 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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:
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OMB control
21 CFR part or guidance Topic No.
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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