Notice2025-12416
Agency Information Collection Activities; Proposed Collection; Comment Request; 510(k) Third-Party Review Program
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 3, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with the 510(k) Third-Party Review Program.
Full Text
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<title>Federal Register, Volume 90 Issue 126 (Thursday, July 3, 2025)</title>
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[Federal Register Volume 90, Number 126 (Thursday, July 3, 2025)]
[Notices]
[Pages 29552-29554]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-12416]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-1108]
Agency Information Collection Activities; Proposed Collection;
Comment Request; 510(k) Third-Party Review Program
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on information collection associated with the
510(k) Third-Party Review Program.
DATES: Either electronic or written comments on the collection of
information must be submitted by September 2, 2025.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of September 2, 2025. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2025-N-1108] for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; 510(k) Third-Party Review
Program.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts
[[Page 29553]]
and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
<a href="/cdn-cgi/l/email-protection#613133203215000707210705004f0909124f060e17"><span class="__cf_email__" data-cfemail="5b0b091a082f3a3d3d1b3d3f3a75333328753c342d">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Agency Information Collection Activities; Proposed Collection; Comment
Request; 510(k) Third-Party Review Program
OMB Control Number 0910-0375--Revision
Section 523 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 360m), directs FDA to accredit persons in the private sector
to review certain premarket notifications (510(k)s; see 21 U.S.C.
360(k)). Participation in the 510(k) third party (3P510k) review
program by accredited persons is entirely voluntary. A third party
wishing to participate will submit a request for accreditation to FDA.
Accredited third-party reviewers have the ability to review a
manufacturer's 510(k) submission for selected devices. After reviewing
a submission, the reviewer will forward a copy of the 510(k)
submission, along with the reviewer's documented review and
recommendation, to FDA. Third-party reviewers should maintain records
of their 510(k) reviews and a copy of the 510(k) for a reasonable
period of time, usually 3 years. The 3P510k review program is intended
to allow review of devices by third-party 510k review organizations
(3PROs) to provide manufacturers of these devices an alternative review
process that allows FDA to best utilize our resources on higher risk
devices.
Respondents to this information collection are businesses or
government and can be for-profit or not-for-profit organizations, such
as third party review organizations.
The guidance ``510(k) Third-Party Review Program, Guidance for
Industry, Food and Drug Administration Staff and Third Party Review
Organizations'' (March 2020) was intended to provide a comprehensive
look into FDA's current thinking regarding the 3P510k program and third
party review of Emergency Use Authorization (EUA) requests by
describing FDA's expectations for the review of 510(k) submissions and
EUA requests by third party review organizations. This guidance
document also reflects section 523 of the FD&C Act, which directs FDA
to issue guidance on the factors that will be used in determining
whether a class I or class II device type, or subset of such device
types, is eligible for review by an accredited person. This guidance
was superseded on November 21, 2024, when FDA issued the final guidance
``510(k) Third Party Review Program and Third Party Emergency Use
Authorization (EUA) Review; Guidance for Industry, Food and Drug
Administration Staff, and Third Party Review Organizations'' (November
2024) (available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-third-party-review-program-and-third-party-emergency-use-authorization-eua-review">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-third-party-review-program-and-third-party-emergency-use-authorization-eua-review</a>). The guidance also includes new
content that outlines how FDA may contract with third party review
organizations to perform reviews of EUA requests (3PEUA review) when
appropriate emergency declaration authorities are active under section
564 of the FD&C Act. (See OMB Control Number 0910-0595.)
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of Total
Activity; guidance document Number of responses per annual Average burden per Total hours
section respondents respondent responses response
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Requests for accreditation 1 1 1 40...................... 40
(initial); Section V.D.
Requests for accreditation 3 1 3 24...................... 72
(re-recognition); Section
V.D.
510(k) reviews conducted by 9 14 126 40...................... 5,040
3PROs; Section V.B.
Complaints; Section V.C..... 1 1 1 0.25 (15 minutes)....... 0.25
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Total................... .............. .............. ........... ........................ 5,152.25
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of Total Average burden
Activity; guidance document section Number of records per annual per Total hours
recordkeepers recordkeeper records recordkeeping
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510(k) reviews conducted by 3PROs; 9 14 126 10 1,260
Section V.B.........................
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Records regarding qualifications to 9 1 9 1 9
receive FDA recognition as a 3PRO;
Section V.C.........................
Recordkeeping system regarding 9 1 9 2 18
complaints; Section V.C.............
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Total............................ .............. .............. ........... ............... 1,287
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Upon review of this information collection, we have adjusted our
burden estimate for the average burden hours required per response for
initial requests for accreditation from 24 to 40 hours to more
accurately reflect the time required based on recent experience of FDA
program staff. This adjustment has resulted in an increase of 15 hours
to the currently approved burden.
Dated: June 26, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-12416 Filed 7-2-25; 8:45 am]
BILLING CODE 4164-01-P
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