Notice2025-23630
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarket Surveillance of Medical Devices
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
December 23, 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 244 (Tuesday, December 23, 2025)</title>
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[Federal Register Volume 90, Number 244 (Tuesday, December 23, 2025)]
[Notices]
[Pages 60106-60107]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-23630]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-1210]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Postmarket
Surveillance of Medical Devices
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 January 21, 2026.
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 0910-0449. 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#6f3f3d2e3c1b0e09092f090b0e4107071c41080019"><span class="__cf_email__" data-cfemail="a9f9fbe8faddc8cfcfe9cfcdc887c1c1da87cec6df">[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.
[[Page 60107]]
Postmarket Surveillance of Medical Devices--21 CFR Part 822
OMB Control Number 0910-0449--Extension
This information collection supports FDA regulations. Section 522
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360l) authorizes
FDA to require a manufacturer to conduct postmarket surveillance (PS)
of any device that meets the criteria set forth in the statute. The PS
regulation establishes procedures that FDA uses to approve and
disapprove PS plans. The regulation provides instructions to
manufacturers, so they know what information is required in a PS plan
submission. FDA reviews PS plan submissions in accordance with 21 CFR
822.15 through 822.19 of the regulation, which describe the grounds for
approving or disapproving a PS plan. In addition, the PS regulation
provides instructions to manufacturers to submit interim and final
reports in accordance with 21 CFR 822.38. To assist respondents with
understanding the applicable statutory and regulatory requirements, we
also developed the interpretive agency guidance entitled, ``Postmarket
Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic
Act'' (October 2022) (available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/postmarket-surveillance-under-section-522-federal-food-drug-and-cosmetic-act">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/postmarket-surveillance-under-section-522-federal-food-drug-and-cosmetic-act</a>). Respondents to
this collection of information are those manufacturers that require PS
of their products.
In the Federal Register of June 6, 2025 (90 FR 25318) 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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Number of Total
21 CFR part/activity Number of responses per annual Average burden Total hours
respondents respondent responses per response
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Sec. Sec. [thinsp]822.9 and 3 1 3 120 360
822.10; PS submission...............
Sec. [thinsp]822.21; Changes to PS 8 1 8 40 320
plan after approval.................
Sec. [thinsp]822.28; Changes to PS 1 1 1 8 8
plan for a device that is no longer
marketed............................
Sec. [thinsp]822.29; Waiver........ 1 1 1 40 40
Sec. [thinsp]822.30; Exemption 1 1 1 40 40
request.............................
Sec. [thinsp]822.38; Periodic 35 3 105 40 4,200
reports.............................
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Total............................ .............. ............... ........... .............. 4,968
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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
21 CFR part/activity Number of records per annual per Total hours
recordkeepers recordkeeper records recordkeeping
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Sec. [thinsp]822.31; Manufacturer 3 1 3 20 60
records.............................
Sec. [thinsp]822.32; Investigator 9 1 9 5 45
records.............................
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Total............................ 105 .............. ........... ............... ...........
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Our estimated burden for the information collection reflects an
increase of 1,890 total burden hours and a corresponding increase 45
total annual responses. This increase is based on internal FDA tracking
data. The number of respondents varies annually, subject to the number
of original plans, plan changes, and interim and final reports (which
are dependent on enrollment progress for each study) received by FDA.
Brian Fahey,
Associate Commissioner for Legislation.
[FR Doc. 2025-23630 Filed 12-22-25; 8:45 am]
BILLING CODE 4164-01-P
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