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[Federal Register Volume 89, Number 225 (Thursday, November 21, 2024)]
[Notices]
[Pages 92128-92130]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-27085]

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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 Review; Guidance for Industry, Food and Drug 
Administration Staff, and Third Party Review Organizations; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance entitled ``510(k) Third Party

[[Page 92129]]

Review Program and Third Party Emergency Use Authorization (EUA) 
Review.'' This guidance provides FDA's current thinking regarding the 
510(k) Third Party (3P510k) Review Program and review of EUA requests 
by a third party review organization (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.

DATES: The announcement of the guidance is published in the Federal 
Register on November 21, 2024.

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-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 SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the 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 the ``510(k) Third Party 
Review Program and Third Party Emergency Use Authorization (EUA) 
Review'' guidance. This 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 conduct an initial review of EUA requests for all 
devices, including in vitro diagnostics, 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 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 review 
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 guidance also 
outlines FDA's current thinking on leveraging the International Medical 
Device Regulators Forum's documents for the 3P510k Review Program. This 
guidance supersedes ``510(k) Third Party Review Program; Guidance for 
Industry, Food and Drug Administration Staff, and Third Party Review 
Organizations'' issued on March 12, 2020 (85 FR 14489).
    A notice of availability of the draft guidance appeared in the 
Federal Register of December 21, 2023 (88 FR

[[Page 92130]]

88395). FDA considered comments received and revised the guidance as 
appropriate in response to the comments, including clarifying the 
relationship between 510k Review Organizations and EUA Third Party 
Review Organizations, and conflicts of interest requirements for 
personnel of Third Party Review Organizations.
    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 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 guidance may do so by 
downloading an electronic copy from the internet. A search capability 
for all Center for Devices and Radiological Health guidance documents 
is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also 
available at https://www.regulations.gov and 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 [email protected] 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:

------------------------------------------------------------------------
                                                            OMB control
21 CFR part; guidance; or FDA form          Topic               No.
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``510(k) Third Party Review         510(k) Third Party         0910-0375
 Program''.                          Review Program.
``Requests for Feedback on Medical  Q-submissions.......       0910-0756
 Device Submissions: The Pre-
 Submission Program and Meetings
 with Food and Drug Administration
 Staff''.
``Emergency Use Authorization of    Emergency Use              0910-0595
 Medical Products and Related        Authorization.
 Authorities; Guidance for
 Industry and Other Stakeholders''.
``Guidance for Industry and Food    CDRH Appeals               0910-0738
 and Drug Administration Staff;      Processes.
 Center for Devices and
 Radiological Health Appeals
 Processes''.
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    Dated: November 12, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-27085 Filed 11-20-24; 8:45 am]
BILLING CODE 4164-01-P
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