Notice2025-20772
Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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
November 24, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Full Text
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<title>Federal Register, Volume 90 Issue 224 (Monday, November 24, 2025)</title>
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[Federal Register Volume 90, Number 224 (Monday, November 24, 2025)]
[Notices]
[Pages 52971-52972]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-20772]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-1108]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by December 24, 2025.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0375. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Amber Barrett, 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#732321322007121515331517125d1b1b005d141c05"><span class="__cf_email__" data-cfemail="451517041631242323052321246b2d2d366b222a33">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Third-Party Review Program
OMB Control Number 0910-0375--Extension
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
[[Page 52972]]
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.)
In the Federal Register of July 3, 2025 (90 FR 29552), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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No. of
Activity; guidance document section No. of responses per Total annual Average burden per response Total hours
respondents respondent responses
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Requests for accreditation (initial); Section 1 1 1 40....................................... 40
V.D.
Requests for accreditation (re-recognition); 3 1 3 24....................................... 72
Section V. D.
510(k) reviews conducted by 3PROs; Section V. 9 14 126 40....................................... 5,040
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 Average burden
Activity; guidance document Number of records per Total annual per Total hours
section recordkeepers recordkeeper records recordkeeping
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510(k) reviews conducted by 9 14 126 10 1,260
3PROs; Section V. B.........
Records regarding 9 1 9 1 9
qualifications to receive
FDA recognition as a 3PRO;
Section V. C................
Recordkeeping system 9 1 9 2 18
regarding 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.
Lowell M. Zeta,
Acting, Deputy Commissioner for Policy, Legislation, and International
Affairs.
[FR Doc. 2025-20772 Filed 11-21-25; 8:45 am]
BILLING CODE 4164-01-P
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