Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Pulse Oximeters, 80312-80314 [2023-25475]

Download as PDF 80312 Federal Register / Vol. 88, No. 221 / Friday, November 17, 2023 / Notices and what additional information is helpful to FDA. Additionally, FDA provided additional transparency regarding how FDA uses information from 506J notifications. These guidances are being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, ‘‘Select Updates for the 506J Guidance: 506J Device List and Additional Notifications,’’ when finalized, will represent the current thinking of FDA on ‘‘Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act.’’ These guidances do 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 Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the internet.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-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This guidance document is also available at https://www.regulations.gov, https:// www.fda.gov/regulatory-information/ search-fda-guidance-documents or https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics. Persons unable to download an electronic copy of ‘‘Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Guidance Dated: November 14, 2023. Lauren K. Roth, Associate Commissioner for Policy. BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES The meeting will be held on February 2, 2024, from 9 a.m. to 6:30 p.m. Eastern Time. DATES: Food and Drug Administration [Docket No. FDA–2023–N–4916] Food and Drug Administration, HHS. Notice; establishment of a public docket; request for comments. ACTION: The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The Committee will discuss an approach to improve the quality of premarket studies and associated methods used to evaluate the khammond on DSKJM1Z7X2PROD with NOTICES 18:57 Nov 16, 2023 Jkt 262001 All meeting participants will be heard, viewed, captioned, and recorded for this advisory committee meeting via an online teleconferencing and/or video conferencing platform. Answers to commonly asked questions about FDA advisory committee meetings may be accessed at: https:// www.fda.gov/AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm408555.htm. FDA is establishing a docket for public comment on this meeting. The docket number is FDA–2023–N–4916. The docket will close on March 4, 2024. Please note that late, untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of March 4, 2024. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date. ADDRESSES: Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments—Pulse Oximeters VerDate Sep<11>2014 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: PO 00000 Frm 00044 OMB control No. Shortages Data Collection ...................................................... performance of pulse oximeters submitted for premarket review, taking into consideration a patient’s skin pigmentation, and patient-reported race and ethnicity. The meeting will be open to the public. FDA is establishing a docket for public comment on this document. [FR Doc. 2023–25458 Filed 11–16–23; 8:45 am] SUMMARY: III. Paperwork Reduction Act of 1995 Topic ‘‘Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act’’. AGENCY: Device Under Section 506J of the FD&C Act’’ or ‘‘Select Updates for the 506J Guidance: 506J Device List and Additional Notifications’’ may send an email request to CDRH-Guidance@ fda.hhs.gov to receive an electronic copy of the document. Please use the document number GUI00021003 and complete title to identify the guidance you are requesting. Fmt 4703 Sfmt 4703 0910–0491 Comments received on or before January 19, 2024, will be provided to the Committee. Comments received after that date will be taken into consideration by FDA. In the event that the meeting is canceled, FDA will continue to evaluate any relevant applications or information, and consider any comments submitted to the docket, as appropriate. You may submit comments 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. E:\FR\FM\17NON1.SGM 17NON1 Federal Register / Vol. 88, No. 221 / Friday, November 17, 2023 / Notices khammond on DSKJM1Z7X2PROD with NOTICES • 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–4916 for ‘‘Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.’’ Received comments, those filed in a timely manner (see ADDRESSES), 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.’’ FDA 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 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 the information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 VerDate Sep<11>2014 18:57 Nov 16, 2023 Jkt 262001 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-201509-18/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. FOR FURTHER INFORMATION CONTACT: Candace Nalls, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5216, Silver Spring, MD 20993–0002, 301–636–0510, Candace.Nalls@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last-minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check FDA’s website at https://www.fda.gov/ AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before the meeting. SUPPLEMENTARY INFORMATION: Agenda: The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing and/or video conferencing platform. On February 2, 2024, the Committee will discuss ongoing concerns that pulse oximeters may be less accurate in individuals with darker skin pigmentation. The Committee will discuss an approach to improve the quality of premarket studies and associated methods used to evaluate the performance of pulse oximeters submitted for premarket review, taking into consideration a patient’s skin pigmentation, and patientreported race and ethnicity. The Committee will 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-thecounter indications, and labeling considerations. PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 80313 FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available on FDA’s website at the time of the advisory committee meeting. Background material and the link to the online teleconference and/or video conference meeting will be available at https:// www.fda.gov/AdvisoryCommittees/ Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link. The meeting will include slide presentations with audio and video components to allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the Committee. All electronic and written submissions submitted to the Docket (see ADDRESSES) on or before January 19, 2024, will be provided to the Committee. Oral presentations from the public will be scheduled between approximately 1:30 p.m. and 3:30 p.m. Eastern Time. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before January 16, 2024. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by January 17, 2024. For press inquiries, please contact the Office of Media Affairs at fdaoma@ fda.hhs.gov or 301–796–4540. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Ann Marie Williams, at Annmarie.Williams@ fda.hhs.gov or 301–796–5966 at least 7 days in advance of the meeting. E:\FR\FM\17NON1.SGM 17NON1 80314 Federal Register / Vol. 88, No. 221 / Friday, November 17, 2023 / Notices FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at https://www.fda.gov/ AdvisoryCommittees/AboutAdvisory Committees/ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. 1001 et seq.). This meeting notice also serves as notice that, pursuant to 21 CFR 10.19, the requirements in 21 CFR 14.22(b), (f), and (g) relating to the location of advisory committee meetings are hereby waived to allow for this meeting to take place using an online meeting platform. This waiver is in the interest of allowing greater transparency and opportunities for public participation, in addition to convenience for advisory committee members, speakers, and guest speakers. No participant will be prejudiced by this waiver, and the ends of justice will be served by allowing for this modification to FDA’s advisory committee meeting procedures. Dated: November 14, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–25475 Filed 11–16–23; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–D–0980] Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ‘‘Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions; Guidance for Industry and Food and Drug Administration Staff.’’ Computational modeling and simulation (CM&S) can be used in a variety of ways in medical device applications, including to perform ‘‘in silico’’ device testing or as part of software embedded in a device. This guidance provides a risk-informed framework for credibility assessment of CM&S used in medical khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:57 Nov 16, 2023 Jkt 262001 device regulatory submissions. The guidance is intended to promote consistency and facilitate efficient review of medical device submissions, to increase confidence in the use of CM&S in regulatory submissions, and to facilitate improved interpretation of CM&S credibility evidence submitted in regulatory submissions. DATES: The announcement of the guidance is published in the Federal Register on November 17, 2023. ADDRESSES: You may submit either electronic or written comments on Agency guidances 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– 2021–D–0980 for ‘‘Assessing the Credibility of Computational Modeling PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 and Simulation in Medical Device Submissions.’’ 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-201509-18/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 guidance document entitled ‘‘Assessing the Credibility of Computational Modeling and Simulation in Medical Device E:\FR\FM\17NON1.SGM 17NON1

Agencies

[Federal Register Volume 88, Number 221 (Friday, November 17, 2023)]
[Notices]
[Pages 80312-80314]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-25475]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-4916]


Anesthesiology and Respiratory Therapy Devices Panel of the 
Medical Devices Advisory Committee; Notice of Meeting; Establishment of 
a Public Docket; Request for Comments--Pulse Oximeters

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming 
public advisory committee meeting of the Anesthesiology and Respiratory 
Therapy Devices Panel of the Medical Devices Advisory Committee (the 
Committee). The general function of the Committee is to provide advice 
and recommendations to FDA on regulatory issues. The Committee will 
discuss an approach to improve the quality of premarket studies and 
associated methods used to evaluate the performance of pulse oximeters 
submitted for premarket review, taking into consideration a patient's 
skin pigmentation, and patient-reported race and ethnicity. The meeting 
will be open to the public. FDA is establishing a docket for public 
comment on this document.

DATES: The meeting will be held on February 2, 2024, from 9 a.m. to 
6:30 p.m. Eastern Time.

ADDRESSES: All meeting participants will be heard, viewed, captioned, 
and recorded for this advisory committee meeting via an online 
teleconferencing and/or video conferencing platform. Answers to 
commonly asked questions about FDA advisory committee meetings may be 
accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    FDA is establishing a docket for public comment on this meeting. 
The docket number is FDA-2023-N-4916. The docket will close on March 4, 
2024. Please note that late, untimely filed comments will not be 
considered. The https://www.regulations.gov electronic filing system 
will accept comments until 11:59 p.m. Eastern Time at the end of March 
4, 2024. Comments received by mail/hand delivery/courier (for written/
paper submissions) will be considered timely if they are received on or 
before that date.
    Comments received on or before January 19, 2024, will be provided 
to the Committee. Comments received after that date will be taken into 
consideration by FDA. In the event that the meeting is canceled, FDA 
will continue to evaluate any relevant applications or information, and 
consider any comments submitted to the docket, as appropriate.
    You may submit comments 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.

[[Page 80313]]

     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-4916 for ``Anesthesiology and Respiratory Therapy Devices 
Panel of the Medical Devices Advisory Committee; Notice of Meeting; 
Establishment of a Public Docket; Request for Comments.'' Received 
comments, those filed in a timely manner (see ADDRESSES), 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.'' FDA 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 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 the 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.

FOR FURTHER INFORMATION CONTACT: Candace Nalls, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5216, Silver Spring, MD 20993-0002, 301-636-0510, 
[email protected], or FDA Advisory Committee Information Line, 
1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in 
the Federal Register about last-minute modifications that impact a 
previously announced advisory committee meeting cannot always be 
published quickly enough to provide timely notice. Therefore, you 
should always check FDA's website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate 
advisory committee meeting link, or call the advisory committee 
information line to learn about possible modifications before the 
meeting.

SUPPLEMENTARY INFORMATION: 
    Agenda: The meeting presentations will be heard, viewed, captioned, 
and recorded through an online teleconferencing and/or video 
conferencing platform. On February 2, 2024, the Committee will discuss 
ongoing concerns that pulse oximeters may be less accurate in 
individuals with darker skin pigmentation. The Committee will discuss 
an approach to improve the quality of premarket studies and associated 
methods used to evaluate the performance of pulse oximeters submitted 
for premarket review, taking into consideration a patient's skin 
pigmentation, and patient-reported race and ethnicity. The Committee 
will 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.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its website prior to the meeting, the 
background material will be made publicly available on FDA's website at 
the time of the advisory committee meeting. Background material and the 
link to the online teleconference and/or video conference meeting will 
be available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting 
link. The meeting will include slide presentations with audio and video 
components to allow the presentation of materials in a manner that most 
closely resembles an in-person advisory committee meeting.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the Committee. 
All electronic and written submissions submitted to the Docket (see 
ADDRESSES) on or before January 19, 2024, will be provided to the 
Committee. Oral presentations from the public will be scheduled between 
approximately 1:30 p.m. and 3:30 p.m. Eastern Time. Those individuals 
interested in making formal oral presentations should notify the 
contact person and submit a brief statement of the general nature of 
the evidence or arguments they wish to present, the names and addresses 
of proposed participants, and an indication of the approximate time 
requested to make their presentation on or before January 16, 2024. 
Time allotted for each presentation may be limited. If the number of 
registrants requesting to speak is greater than can be reasonably 
accommodated during the scheduled open public hearing session, FDA may 
conduct a lottery to determine the speakers for the scheduled open 
public hearing session. The contact person will notify interested 
persons regarding their request to speak by January 17, 2024.
    For press inquiries, please contact the Office of Media Affairs at 
[email protected] or 301-796-4540.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
disabilities. If you require accommodations due to a disability, please 
contact Ann Marie Williams, at [email protected] or 301-
796-5966 at least 7 days in advance of the meeting.

[[Page 80314]]

    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. 1001 et seq.). This meeting notice also serves 
as notice that, pursuant to 21 CFR 10.19, the requirements in 21 CFR 
14.22(b), (f), and (g) relating to the location of advisory committee 
meetings are hereby waived to allow for this meeting to take place 
using an online meeting platform. This waiver is in the interest of 
allowing greater transparency and opportunities for public 
participation, in addition to convenience for advisory committee 
members, speakers, and guest speakers. No participant will be 
prejudiced by this waiver, and the ends of justice will be served by 
allowing for this modification to FDA's advisory committee meeting 
procedures.

    Dated: November 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-25475 Filed 11-16-23; 8:45 am]
BILLING CODE 4164-01-P

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