Federal Register / Vol. 88, No. 244 / Thursday, December 21, 2023 / Notices 88395 

++ TCT’s agreement to provide us 

with a copy of the most current 

accreditation survey together with any 

other information related to the survey 

as we may require (including corrective 

action plans). 

IV. Collection of Information 

Requirements 

This document does not impose 

information collection requirements, 

that is, reporting, recordkeeping or 

third-party disclosure requirements. 

Consequently, there is no need for 

review by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501 et seq.). 

V. Response to Comments 

Because of the large number of public 

comments we normally receive on 

Federal Register documents, we are not 

able to acknowledge or respond to them 

individually. We will consider all 

comments we receive by the date and 

time specified in the ‘‘DATES’’ section 

of this preamble, and when we proceed 

with a subsequent document, we will 

respond to the comments in the 

preamble to that document. 

The Administrator of the Centers for 

Medicare & Medicaid Services (CMS), 

Chiquita Brooks-LaSure, having 

reviewed and approved this document, 

authorizes Trenesha Fultz-Mimms, who 

is the Federal Register Liaison, to 

electronically sign this document for 

purposes of publication in the Federal 

Register. 

Trenesha Fultz-Mimms, 

Federal Register Liaison, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2023–28111 Filed 12–20–23; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–D–2565] 

510(k) Third Party Review Program and 

Third Party Emergency Use 

Authorization (EUA) Review; Draft 

Guidance for Industry, Food and Drug 

Administration Staff, and Third Party 

Review Organizations; 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 ‘‘510(k) Third Party 

Review Program and Third Party 

Emergency Use Authorization (EUA) 

Review.’’ This draft guidance provides 

FDA’s current thinking regarding the 

510(k) Third Party (3P510k) Review 

Program and review of Emergency Use 

Authorizations (EUA) requests by a 

third party review organizations 

(3PEUA review). The 3P510k Review 

Program and 3PEUA review create an 

alternative process for manufacturers to 

seek review of 510(k) submissions and 

EUA requests to assist FDA in reviewing 

in a timely manner. 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 February 20, 2024 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– 

2016–D–2565 for ‘‘510(k) Third Party 

Review Program and Third Party 

Emergency Use Authorization (EUA) 

Review.’’ 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 


khammond on DSKJM1Z7X2PROD with NOTICES
88396 Federal Register / Vol. 88, No. 244 / Thursday, December 21, 2023 / Notices 

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 ‘‘510(k) Third Party 

Review Program and Third Party 

Emergency Use Authorization (EUA) 

Review’’ to the Office of Policy, Center 

for Devices and Radiological Health, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 66, Rm. 

5431, Silver Spring, MD 20993–0002. 

Send one self-addressed adhesive label 

to assist that office in processing your 

request. 

FOR FURTHER INFORMATION CONTACT: 

Joshua Nipper, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 2438, Silver Spring, 

MD 20993–0002, 301–796–6524. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance entitled ‘‘510(k) Third 

Party Review Program and Third Party 

Emergency Use Authorization (EUA) 

Review.’’ This draft guidance updates 

the previously issued ‘‘510(k) Third 

Party Review Program’’ guidance to 

further clarify the 3P510k Review 

Program and outline how FDA may use 

third party review organizations to 

review EUA requests under section 564 

of the Federal Food, Drug, and Cosmetic 

Act (FD&C Act) (21 U.S.C. 360bbb–3) 

and consistent with section 565(i) of the 

FD&C Act (21 U.S.C. 360bbb–4(i)). 

This draft guidance distinguishes 

FDA’s expectations for the 3P510k 

Review Program and for 3PEUA review; 

describes the factors FDA will use in 

determining device type eligibility for 

review by 3P510k Review 

Organizations; describes FDA’s 

expectations for third party 

organizations when conducting 

substantial reviews of 510(k) 

submissions and EUA requests; outlines 

FDA’s process for the recognition, 

rerecognition, suspension, and 

withdrawal of recognition for 3P510k 

Review Organizations; and describes the 

expectations regarding compensation to 

third party review organizations. This 

draft guidance, when final, will also 

outline FDA’s current thinking on 

leveraging the International Medical 

Device Regulators Forum’s documents 

for the 3P510k Review Program. When 

finalized, this guidance will supersede 

the final guidance entitled ‘‘510(k) 

Third Party Review Program; Guidance 

for Industry, Food and Drug 

Administration Staff, and Third Party 

Review Organizations’’ published in the 

Federal Register of March 12, 2020 (85 

FR 14489). 

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 510(k) Third Party Review Program 

and Third Party Emergency Use 

Authorization (EUA) Review. 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 https:// 

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents. 

Persons unable to download an 

electronic copy of ‘‘510(k) Third Party 

Review Program and Third Party 

Emergency Use Authorization (EUA) 

Review’’ may send an email request to 

CDRH-Guidance@fda.hhs.gov to receive 

an electronic copy of the document. 

Please use the document number 

GUI01500013 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; guidance; or FDA form Topic OMB control 

No. 

‘‘510(k) Third-Party Review Program’’ ......................................................................... 510(k) Third-Party Review Program ......... 0910–0375 

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

‘‘Requests for Feedback and Meetings for Medical Device Submissions: The QSubmission Program’’.Q-submissions and Early Payor Feedback Request Programs for Medical 

Devices.

0910–0756 

‘‘Emergency Use Authorization of Medical Products and Related Authorities; Guidance for Industry and Other Stakeholders’’.Emergency Use Authorization .................. 0910–0595 

‘‘Guidance for Industry and Food and Drug Administration Staff; Center for Devices 

and Radiological Health Appeals Processes’’.

Appeals Process ....................................... 0910–0738 

Dated: December 18, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–28095 Filed 12–20–23; 8:45 am] 

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