Notice2026-03857
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
February 26, 2026
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 91 Issue 38 (Thursday, February 26, 2026)</title>
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[Federal Register Volume 91, Number 38 (Thursday, February 26, 2026)]
[Notices]
[Pages 9622-9624]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-03857]
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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) 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 March 30, 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 0910-0078.
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#c595978496b1a4a3a385a3a1a4ebadadb6eba2aab3"><span class="__cf_email__" data-cfemail="efbfbdaebc9b8e8989af898b8ec187879cc1888099">[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.
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 https://
[[Page 9623]]
www.fda.gov/medical-devices/premarket-submissions-selecting-and-
preparing-correct-submission/investigational-device-exemption-ide.
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. The information collection also includes
recommended recordkeeping discussed in the document, ``Guidance on
Informed Consent for In Vitro Diagnostic Device Studies Using Leftover
Human Specimens that are Not Individually Identifiable'' (April 2006),
available for download at GFI IVD Leftover Specimens April 2006, and
previously approved under OMB control no. 0910-0582. The guidance
document explains that FDA does not intend to object to the use,
without informed consent, of leftover human specimens--remnants of
specimens collected for routine clinical care or analysis that would
otherwise have been discarded--in investigations that meet the criteria
for exemption in 21 CFR 812.2(c)(3), as long as subject privacy is
protected by using only specimens that are not individually
identifiable. The guidance document was developed and issued in
accordance with our Good Guidance Practice regulations (21 CFR 10.115),
which provide for public comment at any time.
Table 1--Estimated Annual Reporting Burden \1\ \2\
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Number of
Activity/21 CFR section Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
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812.10; waivers............................. 1 1 1 1......................................... 1
812.20, 812.25, and 812.27; applications, 288 1 288 80........................................ 23,040
investigational plans, and supplements.
812.27(b)(4)(i); prior investigations within 504 1 504 1......................................... 504
the United States.
812.27(b)(4)(ii); prior investigations 126 1 126 0.25 (15 minutes)......................... 32
outside the United States.
812.28; acceptance of data from clinical 1,500 1 1,500 10.25..................................... 15,375
investigations conducted outside the United
States, and supporting information.
812.28(c); waivers.......................... 10 1 10 1......................................... 10
812.35 and 812.150; application supplements. 824 5 4,120 6......................................... 24,720
812.36(c); treatment IDE applications....... 1 1 1 120....................................... 120
812.36(f); treatment IDE reports............ 1 1 1 20........................................ 20
812.150; non-significant risk study reports 1 1 1 6......................................... 6
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.
\2\ Numbers have been rounded.
In the Federal Register of August 22, 2025 (90 FR 41087) 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 2--Estimated Annual Recordkeeping Burden \1\ \2\
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Number of Average burden
Activity/21 CFR section Number of records per Total annual 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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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.
\2\ Numbers have been rounded.
[[Page 9624]]
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.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-03857 Filed 2-25-26; 8:45 am]
BILLING CODE 4164-01-P
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