1150 Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices 

Dated: December 27, 2024. 

Kimberlee Trzeciak, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs. 

[FR Doc. 2024–31539 Filed 1–6–25; 8:45 am] 

BILLING CODE 4164–01–P 

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Recommendations; Draft Guidance for 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. 

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 This draft guidance 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draft guidance also proposes 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 This draft guidance is not final 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written comments on the draft guidance 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draft guidance before it begins work on 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 selfaddressed 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 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices 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 layusers 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 overthe-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-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This 

guidance document is also available at 

https://www.regulations.gov and at 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments. 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 CDRH-Guidance@fda.hhs.gov 

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: 

21 CFR part or guidance Topic OMB control 

No. 

807, subpart E ................................................................................................................................... Premarket notification .......... 0910–0120 

814, subparts A through E ................................................................................................................ Premarket approval .............. 0910–0231 

812 .................................................................................................................................................... Investigational Device Exemption.0910–0078 

860, subpart D .................................................................................................................................. De Novo classification process.0910–0844 

‘‘Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program’’.Q-submissions and Early 

Payor Feedback Request 

Programs for Medical Devices.

0910–0756 

800, 801, 809, and 830 .................................................................................................................... Medical Device Labeling 

Regulations; Unique Device Identification.

0910–0485 


ddrumheller on DSK120RN23PROD with NOTICES1
1152 Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices 

21 CFR part or guidance Topic OMB control 

No. 

820 .................................................................................................................................................... Current Good Manufacturing 

Practice (CGMP); Quality 

System (QS) Regulation.

0910–0073 

50, 56 ................................................................................................................................................ Protection of Human Subjects and Institutional Review Boards.0910–0130 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–D–0053] 

Notifying the Food and Drug 

Administration of a Permanent 

Discontinuance or Interruption in 

Manufacturing of a Device Under 

Section 506J of the Federal Food, 

Drug, and Cosmetic Act; Guidance for 

Industry and Food and Drug 

Administration Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance entitled ‘‘Notifying FDA of a 

Permanent Discontinuance or 

Interruption in Manufacturing of a 

Device Under Section 506J of the FD&C 

Act.’’ This guidance updates the 

previous version of the guidance, of the 

same title, issued on November 17, 

2023, and finalizes the concurrently 

issued draft guidance entitled ‘‘Select 

Updates for the 506J Guidance: 506J 

Device List and Additional 

Notifications.’’ This guidance finalizes a 

list of device product codes for which 

a manufacturer of such devices is 

required to notify FDA in accordance 

with the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) (hereafter 

referred to as the ‘‘506J Device List’’) 

and clarifies that manufacturers may 

submit voluntary notifications regarding 

supply chain issues at any time, 

unrelated to the declaration or potential 

declaration of a public health 

emergency (PHE). 

DATES: The announcement of the 

guidance is published in the Federal 

Register on January 7, 2025. 

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– 

2022–D–0053 for ‘‘Notifying FDA of a 

Permanent Discontinuance or 

Interruption in Manufacturing of a 

Device Under Section 506J of the FD&C 

Act.’’ 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)). 


ddrumheller on DSK120RN23PROD with NOTICES1