Notice2025-16066
Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational Device Exemptions Reports and Records
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
August 22, 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 investigational device exemptions.
Full Text
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<title>Federal Register, Volume 90 Issue 161 (Friday, August 22, 2025)</title>
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[Federal Register Volume 90, Number 161 (Friday, August 22, 2025)]
[Notices]
[Pages 41087-41089]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-16066]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-2549]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Investigational Device Exemptions Reports and Records
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
investigational device exemptions.
DATES: Either electronic or written comments on the collection of
information must be submitted by October 21, 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 October 21, 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.
[Insert docket number xxxxx] for ``Agency Information Collection
Activities; Proposed Collection; Comment Request; Investigational
Device Exemptions Reports and Records''. 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
[[Page 41088]]
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#90c0c2d1c3e4f1f6f6d0f6f4f1bef8f8e3bef7ffe6"><span class="__cf_email__" data-cfemail="87d7d5c6d4f3e6e1e1c7e1e3e6a9efeff4a9e0e8f1">[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.
Investigational Device Exemptions Reports and Records--21 CFR Part 812
OMB Control Number 0910-0078--Extension
This information collection supports implementation of section
520(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 360j(g)), which governs exemption for devices for
investigational use. An investigational device exemption (IDE) allows a
device to be used in investigations involving human subjects in which
the safety and effectiveness of the device is being studied. For more
information regarding IDE, please visit our website at <a href="https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/investigational-device-exemption-ide">https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/investigational-device-exemption-ide</a>.
FDA has promulgated regulations in part 812 (21 CFR part 812)
intended to encourage the discovery and development of useful devices
intended for human use. The regulations set forth the scope and
applicability of exemption requirements for devices for investigational
use, as well as establish application procedures, corresponding
instruction, and provisions for emergency research. The regulations
also provide for requesting waivers from the requirements; and explain
sponsor responsibilities, including requirements for institutional
review board (IRB) review and approval. Finally, the regulations in
part 812, subpart G (21 CFR 812.140, 812.145, and 812.150) provide for
required recordkeeping, the inspection of records, and the preparation
and submission of reports to FDA and/or IRBs that oversee medical
device investigations.
We estimate the burden of this collection of information as
follows:
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity/21 CFR section Number of responses per Total annual Average burden per Total hours
respondents respondent responses response
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812.10; waivers................ 1 1 1 1 1
812.20, 812.25, and 812.27; 288 1 288 80 23,040
applications, investigational
plans, and supplements........
812.27(b)(4)(i); prior 504 1 504 1 504
investigations within the
United States.................
812.27(b)(4)(ii); prior 126 1 126 0.25 32
investigations outside the (15 minutes)
United States.................
812.28; acceptance of data from 1,500 1 1,500 10.25 15,375
clinical investigations
conducted outside the United
States, and supporting
information...................
812.28(c); waivers............. 10 1 10 1 10
812.35 and 812.150; application 824 5 4,120 6 24,720
supplements...................
812.36(c); treatment IDE 1 1 1 120 120
applications..................
812.36(f); treatment IDE 1 1 1 20 20
reports.......................
812.150; non-significant risk 1 1 1 6 6
study reports to third parties
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Total...................... .............. .............. 6,552 .................. 63,828
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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
Activity/21 CFR section Number of records per Total annual Average burden per Total hours
recordkeepers recordkeeper records recordkeeping
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812.2(c)(3); records regarding 700 1 700 4 2,800
leftover specimens not
individually identifiable used
in certain studies............
812.28(d); records for clinical 1,500 1 1,500 1 1,500
investigations conducted
outside United States.........
812.140; retention of records.. 1,249 3.09 3,859 1.9937 7,694
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[[Page 41089]]
Total...................... .............. .............. 6,059 .................. 11,994
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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
overall increase of 9,919 hours and a corresponding increase of 1,033
responses. We attribute this adjustment to an increase in the number of
submissions we received over the last few years.
Dated: August 15, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-16066 Filed 8-21-25; 8:45 am]
BILLING CODE 4164-01-P
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