Document ID: FDA-2016-D-2565-0029
Agency: fda
Document Type: Notice
Title: 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Authorization (EUA) Review; Draft Guidance for Industry, Food and Drug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
Posted Date: 2023-12-21T05:00Z

[Federal Register Volume 88, Number 244 (Thursday, December 21, 2023)]
[Notices]
[Pages 88395-88396]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-28095]

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

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Authorization (EUA) Review; Draft Guidance for Industry, Food and Drug 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the availability of the draft guidance entitled ``510(k) Third Party 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 This draft guidance provides FDA's current thinking regarding 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 This draft guidance is not final nor is it for implementation 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DATES: Submit either electronic or written comments on the draft 
guidance by February 20, 2024 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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

[[Page 88396]]

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-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.
------------------------------------------------------------------------
``510(k) Third-Party Review         510(k) Third-Party         0910-0375
 Program''.                          Review Program.
807, subpart E....................  Premarket                  0910-0120
                                     notification.
``Requests for Feedback and         Q-submissions and          0910-0756
 Meetings for Medical Device         Early Payor
 Submissions: The Q-Submission       Feedback Request
 Program''.                          Programs for
                                     Medical Devices.
``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    Appeals Process.....       0910-0738
 and Drug Administration Staff;
 Center for Devices and
 Radiological Health Appeals
 Processes''.
------------------------------------------------------------------------

    Dated: December 18, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-28095 Filed 12-20-23; 8:45 am]
BILLING CODE 4164-01-P