1146 Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0053] 

Communications From Firms to Health 

Care Providers Regarding Scientific 

Information on Unapproved Uses of 

Approved/Cleared Medical Products: 

Questions and Answers; Guidance for 

Industry; Availability; Agency 

Information Collection Activities; 

Submission for Office of Management 

and Budget Review; Comment Request 

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 for industry entitled 

‘‘Communications From Firms to Health 

Care Providers Regarding Scientific 

Information on Unapproved Uses of 

Approved/Cleared Medical Products: 

Questions and Answers.’’ This guidance 

describes FDA’s enforcement policy 

regarding certain firm-initiated 

communications of scientific 

information on unapproved use(s) of the 

firm’s approved/cleared medical 

products to health care providers (HCPs) 

engaged in prescribing or administering 

medical products to individual patients. 

This guidance finalizes the revised draft 

guidance of the same title issued in 

October 2023. The October 2023 revised 

draft guidance revised and replaced the 

draft guidance entitled ‘‘Distributing 

Scientific and Medical Publications on 

Unapproved New Uses—Recommended 

Practices,’’ issued in March 2014, which 

itself revised the final guidance entitled 

‘‘Good Reprint Practices for the 

Distribution of Medical Journal Articles 

and Medical or Scientific Reference 

Publications on Unapproved New Uses 

of Approved Drugs and Approved or 

Cleared Medical Devices,’’ issued in 

January 2009. This guidance is not for 

current implementation, pending the 

Office of Management and Budget’s 

(OMB’s) decision on the collection of 

information. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on January 7, 2025. Submit 

written comments on the collection of 

information by February 21, 2025. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find the particular information 

collections by selecting ‘‘Currently 

under Review—Open for Public 

Comments’’ or by using the search 

function. The OMB control numbers 

that FDA is seeking to revise are 0910– 

0686 and 0910–0485. Also include the 

FDA docket number found in brackets 

in the heading of this document. 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– 

2008–D–0053 for ‘‘Communications 

From Firms to Health Care Providers 

Regarding Scientific Information on 

Unapproved Uses of Approved/Cleared 

Medical Products: Questions and 

Answers.’’ 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)). 

Submit written requests for single 

copies of this guidance to the Division 

of Drug Information, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002; the Office of Communication, 

Outreach and Development, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

3128, Silver Spring, MD 20993–0002; 

the Office of Policy, Center for Devices 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices 1147 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5431, Silver Spring, 

MD 20993–0002; or the Policy and 

Regulations Staff, Center for Veterinary 

Medicine, Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that 

office in processing your requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Regarding the guidance: Kathleen 

David, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Room 3203, Silver 

Spring, MD 20993–0002, 301–796–1200; 

James Myers, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911; Stephanie Philbin, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 5456, 

Silver Spring, MD 20993–0002, 301– 

837–7151; Kathryn Dennehy, Office of 

Surveillance and Compliance, Center for 

Veterinary Medicine, Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–402–7002; or 

Julie Finegan, Office of Policy, Office of 

the Commissioner, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 4252, Silver Spring, 

MD 20993–0002, 301–827–4830. 

Regarding the information collection: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Communications From Firms to Health 

Care Providers Regarding Scientific 

Information on Unapproved Uses of 

Approved/Cleared Medical Products: 

Questions and Answers.’’ This guidance 

describes FDA’s enforcement policy 

regarding certain firm-initiated 

communications of scientific 

information on unapproved use(s) of the 

firm’s approved/cleared medical 

products to HCPs engaged in prescribing 

or administering medical products to 

individual patients. FDA is issuing this 

guidance to provide reassurance to firms 

that, if they choose to provide 

communications consistent with the 

recommendations in this guidance, FDA 

does not intend to use the firm’s 

dissemination of such communication 

standing alone as evidence of a new 

intended use. Additionally, FDA does 

not expect a firm to submit such a 

communication to the Agency at the 

time the communication is initially 

shared with HCPs. We acknowledge that 

firms communicate in other ways and 

with other audiences, and this guidance 

neither speaks to nor intends to convey 

any views on communications that are 

not within the scope of the enforcement 

policy outlined in this guidance. 

The fact that a communication by a 

firm does not share all the 

characteristics of communications that 

are within the scope of this enforcement 

policy does not alone mean that FDA 

intends to rely on it to establish a new 

intended use. A key tenet underlying 

this enforcement approach is that, to 

promote the public health, any 

individual firm-initiated 

communication of scientific information 

about unapproved use(s) of that firm’s 

approved/cleared medical product(s) 

should be truthful and non-misleading, 

and provide and appropriately present 

all information necessary for HCPs to 

understand and evaluate the strengths 

and weaknesses, validity, and clinical 

utility of the scientific information on 

unapproved use(s) in that specific 

communication. Accordingly, the 

guidance provides recommendations 

consistent with those principles. The 

guidance also describes the 

characteristics of the specific source 

publications contained in firm-initiated 

communications that fall within the 

enforcement policy outlined in this 

guidance. 

Specifically, this guidance provides 

recommendations for firms initiating the 

sharing with HCPs of: 

• Source publications that are: 

—Published scientific or medical 

journal articles (reprints) 

—Published clinical reference 

resources, as follows: 

D Clinical practice guidelines (CPGs) 

D Scientific or medical reference texts 

(reference texts) 

D Materials from digital clinical practice 

resources 

• Firm-generated presentations of 

scientific information on unapproved 

use(s) provided with a source 

publication 

For the purposes of this guidance, 

these specific types of firm-initiated 

communications to HCPs, in 

combination with the disclosures 

recommended in this guidance, are 

referred to as scientific information on 

unapproved use(s) of approved/cleared 

medical product communications 

(hereafter referred to as ‘‘SIUU 

communications’’). 

This guidance finalizes the revised 

draft guidance of the same title issued 

in October 2023 (88 FR 73031). FDA 

considered comments received on the 

draft guidance as the guidance was 

finalized. Changes from the draft to the 

final guidance include (1) reorganizing 

the guidance to include dedicated 

glossary and policy sections; (2) revising 

the recommendations for source 

publications to provide additional 

specificity and examples to illustrate the 

recommendations; (3) refining language 

around presentational considerations to 

provide additional clarity and an 

additional example; and (4) updating 

the section on firm-generated 

presentations to specify that the 

recommendations apply to firmgenerated presentations of scientific 

information from any of the source 

publications addressed in the guidance. 

In addition, editorial changes were 

made for clarity. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Communications 

From Firms to Health Care Providers 

Regarding Scientific Information on 

Unapproved Uses of Approved/Cleared 

Medical Products: Questions and 

Answers.’’ 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. Paperwork Reduction Act of 1995 

In compliance with 44 U.S.C. 3507, 

FDA has submitted the following 

proposed collection of information for 

OMB review and clearance. This 

guidance is not for current 

implementation, pending OMB’s 

decision on the collection of 

information. 

Manufacturer Communications on 

Approved and Unapproved Uses of 

Drugs OMB Control Number 0910– 

0686—Revision; and Medical Device 

Labeling 

OMB Control No. 0910–0485—Revision 

The guidance document entitled 

‘‘Communications From Firms to Health 

Care Providers Regarding Scientific 

Information on Unapproved Uses of 

Approved/Cleared Medical Products: 

Questions and Answers’’ discusses 

third-party disclosure recommendations 

regarding information that we 

recommend firms include in SIUU 


ddrumheller on DSK120RN23PROD with NOTICES1
1148 Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices 

communications if the firms choose to 

publicly share such communications. 

In the Federal Register of October 24, 

2023 (88 FR 73031), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received in response to the four 

information collection topics solicited 

in the notice. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN—OMB CONTROL NO. 0910–0686 1

Information collection activity; guidance section Number of 

respondents 

Number of 

disclosures per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 

A statement that the unapproved use(s) of the medical product has not 

been approved by FDA and that the safety and effectiveness of the 

medical product for the unapproved use(s) has not been established; 

section V. Q2.

747 30 22,410 0.1 (6 minutes) ..... 2,241 

A statement disclosing the FDA-approved use(s) of the medical product, 

including any limitations of use specified in the FDA-required labeling; 

section V. Q2.

747 27 20,169 0.1 (6 minutes) ..... 2,016.9 

A statement disclosing any limitations, restrictions, cautions, warnings, 

or precautions described in the FDA-required labeling about the unapproved use(s); section V. Q2.

747 5 3,735 0.2 (12 minutes) ... 747 

A copy of the most current FDA-required labeling (or a mechanism for 

obtaining this labeling, as appropriate); section V. Q2.

747 27 20,169 0.1 (6 minutes) ..... 2,016.9 

A statement describing any contraindication(s) in the FDA-required labeling for the medical product; section V. Q2.747 3 2,241 0.1 (6 minutes) ..... 224.1 

A statement describing any serious, life-threatening, or fatal risks posed 

by the medical product that are in the FDA-required labeling for the 

medical product or known by the firm and that are relevant to the unapproved use(s). If a risk evaluation and mitigation strategy (REMS) 

has been established under 21 U.S.C. 355–1, the statement should 

disclose that fact and should describe the goal(s) of the REMS; section V. Q2.

747 25 18,675 0.2 (12 minutes) ... 3,735 

A statement identifying any authors, editors, or other contributors to publication(s) included in the SIUU communication who were employees 

of or consultants to or who received compensation from the firm at the 

time of writing, editing, or contributing to the publication, to the extent 

a firm acting reasonably would know of such relationship; section V. 

Q2.

747 20 14,940 0.2 (12 minutes) ... 2,988 

In the case of an SIUU communication that includes one or more source 

publications primarily focused on a particular scientific study or studies, for each such study where the following information is not included in the source publication, provide a description of:.

747 20 14,940 2.75 ...................... 41,085 

—All material aspects of study design, methodology, and results; 

—All material limitations related to the study design, methodology, 

and results; 

—Any conclusions—from other scientifically sound studies that 

evaluated the same or similar hypotheses or research questions—that are in conflict with the conclusions from the studies or 

analyses described in the source publication(s). The citations for 

any such studies should also be included; section V. Q2. 

The publication date of any referenced or included source publication (if 

not specified in the source publication or citation); section V. Q2.

747 3 2,241 0.1 (6 minutes) ..... 224.1 

When a firm shares an SIUU communication that does not include a 

firm-generated presentation, but does include an unabridged CPG or 

reference text in its entirety that discusses a wide range of medical 

products and that discussion is not primarily focused on one or more 

of a firm’s medical products, the firm should include, in lieu of some of 

the specific disclosures listed above, a more general statement in the 

SIUU communication, such as ‘‘This [CPG/reference text] describes 

some uses of medical products that are not approved by FDA, and 

the safety and effectiveness of any unapproved use(s) have not been 

established.’’; section V. Q4.

747 3 2,241 0.1 (6 minutes) ..... 224.1 

When a firm shares an SIUU communication that includes a firm-generated presentation of scientific information on unapproved use(s) provided with a source publication, that SIUU communication should 

clearly disclose what portions of the SIUU communication are firmgenerated; section V. Q5.

747 10 7,470 0.1 (6 minutes) ..... 747 

Total .................................................................................................... ........................ ............................ 129,231 ............................... 56,249.1 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Based on a current listing of firms 

promoting human and animal drug 

products in calendar year (CY) 2022, we 

assume 747 firms (‘‘number of 

respondents’’ in table 1) may each 

choose to publicly share 30 SIUU 

communications annually. Our estimate 

of the burden per disclosure (2.5 hours) 

reflects what we believe is the average 

burden based on the number and 

content and complexity of disclosures 

as recommended in the guidance. 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices 1149 

TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN—OMB CONTROL NO. 0910–0485 1

Information collection activity; guidance section Number of 

respondents 

Number of 

disclosures per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 

A statement that the unapproved use(s) of the medical product has not 

been approved by FDA and that the safety and effectiveness of the 

medical product for the unapproved use(s) has not been established; 

section V. Q2.

261 30 7,830 0.1 (6 minutes) ..... 783 

A statement disclosing the FDA-approved use(s) of the medical product, 

including any limitations of use specified in the FDA-required labeling; 

section V. Q2.

261 27 7,047 0.1 (6 minutes) ..... 704.7 

A statement disclosing any limitations, restrictions, cautions, warnings, 

or precautions described in the FDA-required labeling about the unapproved use(s); section V. Q2.

261 5 1,305 0.2 (12 minutes) ... 261 

A copy of the most current FDA-required labeling (or a mechanism for 

obtaining this labeling, as appropriate); section V. Q2.

261 27 7,047 0.1 (6 minutes) ..... 704.7 

A statement describing any contraindication(s) in the FDA-required labeling for the medical product; section V. Q2.261 3 783 0.1 (6 minutes) ..... 78.3 

A statement describing any serious, life-threatening, or fatal risks posed 

by the medical product that are in the FDA-required labeling for the 

medical product or known by the firm and that are relevant to the unapproved use(s). If a risk evaluation and mitigation strategy (REMS) 

has been established under 21 U.S.C. 355–1, the statement should 

disclose that fact and should describe the goal(s) of the REMS; section V. Q2.

261 25 6,525 0.2 (12 minutes) ... 1,305 

A statement identifying any authors, editors, or other contributors to publication(s) included in the SIUU communication who were employees 

of or consultants to or who received compensation from the firm at the 

time of writing, editing, or contributing to the publication, to the extent 

a firm acting reasonably would know of such relationship; section V. 

Q2.

261 20 5,220 0.2 (12 minutes) ... 1,044 

In the case of an SIUU communication that includes one or more source 

publications primarily focused on a particular scientific study or studies, for each such study where the following information is not included in the source publication, provide a description of:.

261 20 5,220 2.75 ...................... 14,355

—All material aspects of study design, methodology, and results 

—All material limitations related to the study design, methodology, 

and results 

—Any conclusions—from other scientifically sound studies that 

evaluated the same or similar hypotheses or research questions—that are in conflict with the conclusions from the studies or 

analyses described in the source publication(s). The citations for 

any such studies should also be included; section V. Q2 

The publication date of any referenced or included source publication (if 

not specified in the source publication or citation); section V. Q2.

261 3 783 0.1 (6 minutes) ..... 78.3 

When a firm shares an SIUU communication that does not include a 

firm-generated presentation, but does include an unabridged CPG or 

reference text in its entirety that discusses a wide range of medical 

products and that discussion is not primarily focused on one or more 

of a firm’s medical products, the firm should include, in lieu of some of 

the specific disclosures listed above, a more general statement in the 

SIUU communication, such as ‘‘This [CPG/reference text] describes 

some uses of medical products that are not approved by FDA and the 

safety and effectiveness of any unapproved use(s) have not been established.’’; section V. Q4.

261 3 783 0.1 (6 minutes) ..... 78.3 

When a firm shares an SIUU communication that includes a firm-generated presentation of scientific information on unapproved use(s) provided with a source publication, that SIUU communication should 

clearly disclose what portions of the SIUU communication are firmgenerated; section V. Q5.

261 10 2,610 0.1 (6 minutes) ..... 261 

Total .................................................................................................... ........................ ............................ 45,153 ............................... 19,653.3 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Based on an estimated number of 

device firms marketing products in 

calendar year (CY) 2022, we assume 261 

firms (‘‘number of respondents’’ in table 

1) may each choose to publicly share 30

SIUU communications annually. Our

estimate of the burden per disclosure

(2.5 hours) reflects what we believe is

the average burden based on the number

and content and complexity of

disclosures as recommended in the

guidance.

FDA is issuing this final guidance 

subject to OMB approval of the 

collection of information. Before 

implementing the guidance, FDA will 

publish a notice in the Federal Register 

announcing OMB’s decision to approve, 

modify, or disapprove the collection of 

information. 

III. Electronic Access

Persons with access to the internet

may obtain the guidance at https://

www.fda.gov/Drugs/ 

GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm, https://www.fda.gov/ 

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://

www.fda.gov/MedicalDevices/ 

DeviceRegulationandGuidance/ 

GuidanceDocuments/default.htm, 

https://www.fda.gov/animal-veterinary/ 

guidance-regulations/guidanceindustry, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 


ddrumheller on DSK120RN23PROD with NOTICES1
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