Notice2025-14945
Agency Information Collection Activities; Proposed Collection; 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
August 7, 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 related to humanitarian use devices (HUDs) and humanitarian device exemption (HDE).
Full Text
<html>
<head>
<title>Federal Register, Volume 90 Issue 150 (Thursday, August 7, 2025)</title>
</head>
<body><pre>
[Federal Register Volume 90, Number 150 (Thursday, August 7, 2025)]
[Notices]
[Pages 38151-38154]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-14945]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-2195]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Devices; Humanitarian Use Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 related to
humanitarian use devices (HUDs) and humanitarian device exemption
(HDE).
DATES: Either electronic or written comments on the collection of
information must be submitted by October 6, 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 6, 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-2195 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Medical Devices; Humanitarian Use
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#1d4d4f5c4e697c7b7b5d7b797c3375756e337a726b"><span class="__cf_email__" data-cfemail="19494b584a6d787f7f597f7d783771716a377e766f">[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.
[[Page 38152]]
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.
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 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 https://www.fda.gov/
medical-
[[Page 38153]]
devices/how-study-and-market-your-device/ecopy-medical-device-
submissions 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>).
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\ \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity/21 CFR part/form Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Humanitarian Use Devices; 21 CFR Part 814
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
---------------------------------------------------------------------------------------------------------
Total..................................... .............. .............. .............. ........................................ 22,040
--------------------------------------------------------------------------------------------------------------------------------------------------------
Information to Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
---------------------------------------------------------------------------------------------------------
Total..................................... .............. .............. .............. ........................................ 360
---------------------------------------------------------------------------------------------------------
Reporting Total....................... .............. .............. .............. ........................................ 22,400
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity/21 CFR part Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Humanitarian Use Devices; 21 CFR Part 814
--------------------------------------------------------------------------------------------------------------------------------------------------------
HDE Records--814.126(b)(2)......................................... 81 1 81 2 162
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity/21 CFR section Number of disclosures per Total annual Average burden Total hours
respondents respondent disclosures per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Humanitarian Use Devices; 21 CFR Part 814
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notification of emergency use--814.124(a).......................... 22 1 22 1 22
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
[[Page 38154]]
Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub.
L. 112-144), which amended section 520(m) of the FD&C Act.
Dated: July 31, 2025.
Grace R. Graham
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-14945 Filed 8-6-25; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on August 7, 2025.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.