Notice2025-22278
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Humanitarian Use 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 9, 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 234 (Tuesday, December 9, 2025)</title>
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[Federal Register Volume 90, Number 234 (Tuesday, December 9, 2025)]
[Notices]
[Pages 57067-57070]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-22278]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-2195]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Devices;
Humanitarian Use 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 8, 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 0910-0332. 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#f8a8aab9ab8c999e9eb89e9c99d690908bd69f978e"><span class="__cf_email__" data-cfemail="316163706245505757715755501f5959421f565e47">[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.
Medical Devices; Humanitarian Use Devices--21 CFR part 814
OMB Control Number 0910-0332--Extension
This collection of information implements the humanitarian use
devices (HUDs) provision of section 520(m) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 360j(m)) and part 814, subpart H
(21 CFR part 814, subpart H). Under section 520(m) of the FD&C Act, FDA
is authorized to exempt an HUD from the
[[Page 57068]]
effectiveness requirements of sections 514 and 515 of the FD&C Act (21
U.S.C. 360d and 360e) provided that the device: (1) is designed to
treat or diagnose a disease or condition that affects no more than
8,000 individuals in the United States; (2) would not be available to a
person with a disease or condition unless an exemption is granted and
there is no comparable device other than another HUD approved under
this exemption that is available to treat or diagnose such disease or
condition; and (3) will not expose patients to an unreasonable or
significant risk of illness or injury and the probable benefit to
health from the use of the device outweighs the risk of injury or
illness from its use, taking into account the probable risks and
benefits of currently available devices or alternative forms of
treatment.
Respondents may submit a humanitarian device exemption (HDE)
application seeking exemption from the effectiveness requirements of
sections 514 and 515 of the FD&C Act as authorized by section 520(m)(2)
of the FD&C Act. The information collected will assist FDA in making
determinations on the following: (1) whether to grant HUD designation
of a medical device; (2) whether to exempt an HUD from the
effectiveness requirements under sections 514 and 515 of the FD&C Act,
provided that the device meets requirements set forth under section
520(m) of the FD&C Act; and (3) whether to grant marketing approval(s)
for the HUD. Failure to collect this information would prevent FDA from
making a determination on the factors listed previously in this
document. Further, the collected information would also enable FDA to
determine whether the holder of an HUD is in compliance with the HUD
provisions under section 520(m) of the FD&C Act.
HUDs approved under a HDE cannot be sold for an amount that exceeds
the costs of research and development, fabrication, and distribution of
the device (i.e., for profit), except in narrow circumstances. Section
520(m)(6)(A)(i) of the FD&C Act, provides that a HUD approved under an
HDE is eligible to be sold for profit if the device meets certain
criteria: The device is intended for the treatment or diagnosis of a
disease or condition that occurs in pediatric patients or in a
pediatric subpopulation, and such device is labeled for use in
pediatric patients or in a pediatric subpopulation in which the disease
or condition occurs; or the device is intended for the treatment or
diagnosis of a disease or condition that does not occur in pediatric
patients, or that occurs in pediatric patients in such numbers that the
development of the device for such patients is impossible, highly
impracticable, or unsafe.
Section 520(m)(6)(A)(ii) provides that the Secretary of Health and
Human Services (the Secretary) will assign an annual distribution
number (ADN) for devices that meet the eligibility criteria to be
permitted to be sold for profit. The ADN is defined as the number of
devices ``reasonably needed to treat, diagnose, or cure a population of
8,000 individuals in the United States,'' and therefore shall be based
on the following information in a HDE application: the number of
devices reasonably necessary to treat such individuals.
Section 520(m)(6)(A)(iii) provides that an HDE holder immediately
notify the agency if the number of devices distributed during any
calendar year exceeds the ADN. Section 520(m)(6)(C) provides that an
HDE holder may petition to modify the ADN if additional information
arises.
The FDA issued guidance entitled ``Humanitarian Device Exemption
(HDE) Program (September 2019) (<a href="http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm110203.pdf">http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm110203.pdf</a>), which addresses commonly asked questions about HDEs and
HUDs, including FDA actions on HDE applications, post-approval
requirements, and special considerations for devices marketed under the
HDE Program. The guidance document reflects changes in the HDE Program
resulting from statutory amendments made by the 21st Century Cures Act
(Cures Act) and explains the criteria FDA considers to determine if
``probable benefit'' has been demonstrated as part of the Agency's
decision-making process regarding marketing authorization for a HUD.
This guidance document also reflects amendments made to the HDE
provision of the FD&C Act by the FDA Reauthorization Act of 2017
(FDARA).
Section 402(j)(5)(B) (42 U.S.C. 282(j)(5)(b)) of the Public Health
Service Act (PHS Act), requires a certification to accompany human
drug, biological, and device product submissions made to FDA.
Specifically, at the time of submission of an application under
sections 505, 515, or 520(m) of the FD&C Act (21 U.S.C. 354, 360e, or
360j(m)), or under section 351 of the PHS Act (42 U.S.C. 262), or
submission of a report under section 510(k) of the FD&C Act (21 U.S.C.
360(k)), such application or submission must be accompanied by a
certification that all applicable requirements of section 402(j) of the
PHS Act have been met. Relevant regulations are found in 21 CFR parts
814, subpart H (humanitarian use devices--HUDs), and discussed in FDA's
notice of implementation of the certification on December 12, 2007 (72
FR 70599). Certification is made via form FDA 3674, ``Certification of
Compliance (<a href="https://www.fda.gov/media/134964/download">https://www.fda.gov/media/134964/download</a>)--Under 42 U.S.C.
282(j)(5)(B), with Requirements of <a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> Data Bank.''
HUDs are subject to the general restriction that no profit may be
made on their use. For HUDs labeled for use in certain populations, FDA
exempts a certain number of these devices each year from the
prohibition on profit. This number is known as the annual distribution
number (ADN). The information gathered by this collection enables FDA
to set this number. Failure to collect this information would prevent
FDA from assigning an ADN.
The information is submitted to FDA as an ``eCopy'' via FDA's
Center for Devices and Radiological Health (CDRH) Customer
Collaboration Portal (<a href="https://www.fda.gov/medical-devices/industry-medical-devices/send-and-track-medical-device-premarket-submissions-online-cdrh-portal">https://www.fda.gov/medical-devices/industry-medical-devices/send-and-track-medical-device-premarket-submissions-online-cdrh-portal</a>). Instructions and information regarding eCopy
submission are available on FDA's website at <a href="https://www.fda.gov/medical-devices/how-study-and-market-your-device/ecopy-medical-device-submissions">https://www.fda.gov/medical-devices/how-study-and-market-your-device/ecopy-medical-device-submissions</a> and in the FDA guidance document, ``eCopy Program for
Medical Device Submissions'' (<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/ecopy-program-medical-device-submissions">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/ecopy-program-medical-device-submissions</a>).
In the Federal Register of August 7, 2025 (90 FR 38151) 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:
[[Page 57069]]
Table 1--Estimated Annual Reporting Burden 1 2
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Number of
Activity/21 CFR Part/Form Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
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Humanitarian Use Devices; 21 CFR Part 814
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Request for HUD designation--814.102.......... 23 1 23 40...................................... 920
Certification of Compliance (form FDA 3674) 4 1 4 .75 (45 minutes)........................ 3
\2\.
HDE Application--814.104...................... 3 1 3 328..................................... 984
HDE Amendments and resubmitted HDEs--814.106.. 3 3 9 50...................................... 450
HDE Supplements--814.108...................... 30 1 30 80...................................... 2,400
Procedures for review of an HDE, including a 1 1 1 1....................................... 1
request for withdrawal--814.116.
Notification of withdrawal of institutional 1 1 1 2....................................... 2
review board approval--814.124(b).
Periodic reports--814.126(b)(1)............... 36 4 144 120..................................... 17,280
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Total..................................... .............. .............. .............. ........................................ 22,040
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Information to Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements
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Pediatric Subpopulation and Patient 1 1 1 100..................................... 100
Information--515A(a)(2) of the FD&C Act.
Exemption from Profit Prohibition Information-- 1 1 1 50...................................... 50
520(m)(6)(A)(i) and (ii) of the FD&C Act.
Request for Determination of Eligibility 1 1 1 10...................................... 10
Criteria--613(b) of FDASIA.
ADN Notification--520(m)(6)(A)(iii) of the 1 1 1 100..................................... 100
FD&C Act.
ADN Modification--520(m)(6)(C) of the FD&C Act 1 1 1 100..................................... 100
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Total..................................... .............. .............. .............. ........................................ 360
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Reporting Total....................... .............. .............. .............. ........................................ 22,400
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Form FDA 3674 is approved under OMB Control No. 0910-0120. This ICR includes burden only for HUD submissions.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of Average burden
Activity/21 CFR Part Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
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Humanitarian Use Devices; 21 CFR Part 814
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HDE Records--814.126(b)(2)......................................... 81 1 81 2 162
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
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Number of
Activity/21 CFR Section Number of disclosures per Total annual Average burden Total hours
respondents respondent disclosures per disclosure
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Humanitarian Use Devices; 21 CFR Part 814
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Notification of emergency use--814.124(a)........................ 22 1 22 1 22
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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 decrease of 321 hours and a corresponding decrease of 63
responses. The total hour burden for this information collection is
estimated to be 22,584 hours. In a nonmaterial/non-substantive change
request (83-C), approved 3/24/2023, we consolidated the information
collection activity previously approved under OMB control number 0910-
0661 into this information collection. This includes information
collection associated with the annual distribution number reporting
requirements related to pediatric patients and pediatric populations
under section 613 of the Food and Drug Administration Safety and
Innovation Act (FDASIA) (Pub. L. 112-144), which amended section 520(m)
of the FD&C Act. The consolidation also included FDA guidance entitled
``Guidance for HDE Holders, Institutional Review Boards (IRBs),
Clinical Investigators, and Food and Drug Administration Staff--
Humanitarian Device Exemption (HDE) Regulation: Questions and Answers''
(HDE guidance) (July 2010, updated September 2019) (<a href="http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm110203.pdf">http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm110203.pdf</a>). The guidance does not affect the
[[Page 57070]]
estimated burden estimates in this extension.
Lowell M. Zeta,
Acting, Deputy Commissioner for Policy, Legislation, and International
Affairs.
[FR Doc. 2025-22278 Filed 12-8-25; 8:45 am]
BILLING CODE 4164-01-P
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