Notice2025-10885
Agency Information Collection Activities; Proposed Collection; 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
June 16, 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 requirements for postmarket surveillance of medical devices.
Full Text
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<title>Federal Register, Volume 90 Issue 114 (Monday, June 16, 2025)</title>
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[Federal Register Volume 90, Number 114 (Monday, June 16, 2025)]
[Notices]
[Pages 25318-25319]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-10885]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-1210]
Agency Information Collection Activities; Proposed Collection;
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 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 requirements for
postmarket surveillance of medical devices.
DATES: Either electronic or written comments on the collection of
information must be submitted by August 15, 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 August 15, 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-1210] for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Postmarket Surveillance of
Medical Devices.'' 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 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#66363427351207000026000207480e0e1548010910"><span class="__cf_email__" data-cfemail="5d0d0f1c0e293c3b3b1d3b393c7335352e733a322b">[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
[[Page 25319]]
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.
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.
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. 822.9 and 822.10; PS 3 1 3 120 360
submission...........................
Sec. 822.21; Changes to PS plan 8 1 8 40 320
after approval.......................
Sec. 822.28; Changes to PS plan for 1 1 1 8 8
a device that is no longer marketed..
Sec. 822.29; Waiver................. 1 1 1 40 40
Sec. 822.30; Exemption request...... 1 1 1 40 40
Sec. 822.38; Periodic reports....... 35 3 105 40 4,200
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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. 822.31; Manufacturer records... 3 1 3 20 60
Sec. 822.32; Investigator records... 9 1 9 5 45
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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.
Dated: June 9, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-10885 Filed 6-13-25; 8:45 am]
BILLING CODE 4164-01-P
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