Notice2025-13050
Agency Information Collection Activities; Proposed Collection; Comment Request; Q-Submission and Early Payor Feedback Request Programs and Medical Device Development Tools
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Published
July 14, 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 revision 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 associated with the Q-Submission and Early Payor Feedback Request Programs for medical devices and Qualification of Medical Device Development Tools.
Full Text
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<title>Federal Register, Volume 90 Issue 132 (Monday, July 14, 2025)</title>
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[Federal Register Volume 90, Number 132 (Monday, July 14, 2025)]
[Notices]
[Pages 31225-31228]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-13050]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-1812]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Q-Submission and Early Payor Feedback Request Programs
and Medical Device Development Tools
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,
[[Page 31226]]
including each proposed revision 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 associated with the Q-Submission and Early Payor Feedback
Request Programs for medical devices and Qualification of Medical
Device Development Tools.
DATES: Either electronic or written comments on the collection of
information must be submitted by September 12, 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 September 12, 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-1812 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Q-Submission and Early Payor
Feedback Request Programs for 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, 304-796-8867,
<a href="/cdn-cgi/l/email-protection#603032213314010606200604014e0808134e070f16"><span class="__cf_email__" data-cfemail="6c3c3e2d3f180d0a0a2c0a080d4204041f420b031a">[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 revision 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.
Q-Submission and Early Payor Feedback Request Programs and Medical
Device Development Tools
OMB Control Number 0910-0756--Revision
The guidance entitled ``Requests for Feedback and Meetings for
Medical Device Submissions: The Q-Submission Program'' (May 2025)
(available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-medical-device-submissions-q-submission-program">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-medical-device-submissions-q-submission-program</a>) provides an overview of the
mechanisms available to submitters through which they can
[[Page 31227]]
request feedback from or a meeting with FDA regarding certain potential
or planned medical device submissions reviewed by the Center for
Devices and Radiological Health (CDRH) and the Center for Biologics
Evaluation and Research (CBER). The guidance provides recommendations
regarding certain types of Q-Submissions, such as Pre-Submissions,
Submission Issue Requests, Study Risk Determinations, Informational
Meetings, and other Q-Submission Types and other uses of the Q-
Submission Program.
Recent updates in May 2025 to the Q-Submission guidance moved the
instructions for information collection related to requests for
feedback regarding development of a Medical Device Development Tool
(MDDT), which were previously tracked as Informational Meeting Q-
Submissions. We are revising this information collection to add the FDA
guidance entitled ``Qualification of Medical Device Development Tools:
Guidance for Industry, Tool Developers, and Food and Drug
Administration Staff'' (July 2023) (available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/qualification-medical-device-development-tools">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/qualification-medical-device-development-tools</a>), which includes instructions for
submitting requests for feedback regarding MDDTs. The submission
instructions are otherwise unchanged, but the MDDT guidance is now the
collection instrument associated with the existing MDDT burden.
Early Payor Feedback Program
Prior to submitting a Pre-Submission, medical device sponsors may
request that one or more payor organizations join a Pre-Submission
meeting. Payors include public payors such as Centers for Medicare &
Medicaid Services, private health plans, health technology assessment
groups, and others who provide input into coverage, procurement, and
reimbursement decisions. To facilitate such opportunities to obtain
payor input, FDA provides information about our Early Payor Feedback
Program (EPFP) and a list of current payor participants on our website
(available at <a href="https://www.fda.gov/about-fda/cdrh-innovation/payor-communication-task-force#2">https://www.fda.gov/about-fda/cdrh-innovation/payor-communication-task-force#2</a>). For payors to decide which devices to
provide feedback on, we have developed a voluntary form for
manufacturers to provide basic information regarding their device. This
form is shared with the payors from whom the manufacturer is requesting
feedback.
eSTAR for Q-Submissions
Under section 745A(b) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 379k-1(b)), amended by section 207 of the FDA
Reauthorization Act of 2017 (Pub. L. 115-52), and consistent with the
Medical Device User Fee Amendments 2017 (MDUFA IV) Commitment Letter
and the FDA guidance document entitled ``Providing Regulatory
Submissions for Medical Devices in Electronic Format--Submissions Under
Section 745A(b) of the Federal Food, Drug, and Cosmetic Act'' (July
2020) (available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-medical-devices-electronic-format-submissions-under-section-745ab">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-medical-devices-electronic-format-submissions-under-section-745ab</a>), FDA has
developed an ``electronic Submission Template and Resource'' (eSTAR)
for Q-submissions to facilitate the preparation of submissions in
electronic format (available at <a href="https://www.fda.gov/medical-devices/how-study-and-market-your-device/estar-program">https://www.fda.gov/medical-devices/how-study-and-market-your-device/estar-program</a>). The use of eSTAR for
Q-Submissions is currently voluntary.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden 1 2
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No. of
Activity No. of responses per Total annual Average burden Total hours
respondents respondent responses per response
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``Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program''
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Q-Submissions:
CDRH........................ 5,750 1 5,750 137 787,750
CBER........................ 60 1 60 137 8,220
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Q-Submissions using eSTAR:
CDRH........................ 850 1 850 69 58,650
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CBER........................ 40 1 40 69 2,760
eSTAR setup................. 1,480 1 1,480 0.08 118
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Early Payor Feedback Program (EPFP)
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Manufacturer request to 35 1 35 2 70
participate in EPFP............
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Medical Device Development Tools (MDDT)
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MDDT Submissions................ 50 1 50 137 6,850
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Total....................... .............. .............. .............. .............. 864,418
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\1\ Numbers are rounded.
\2\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Based on our experience with the Q-Submission and Early Payor
Feedback Request Programs and Medical Device Development Tools, our
estimated burden for the information collection reflects an overall
increase of 451,180 hours and 4,535 responses annually. We attribute
this adjustment to an increase in the number of respondents according
to FDA data. As discussed above, recent updates to the Q-Submission
guidance moved the instructions for information collection related to
requests for feedback regarding development of MDDTs to the MDDT
guidance. MDDT proposal and qualification packages were previously
tracked as Informational Meeting Q-Submissions.
[[Page 31228]]
The MDDT submission instructions and previously approved burden
estimate are otherwise unchanged, but the MDDT guidance is now the
collection instrument associated with the existing MDDT burden.
Accordingly, we have moved the burden for MDDT submissions to a
distinct line item in the burden table to reflect the updated
collection instrument. There is no new collection of information
occurring in this revision. However, submissions related to MDDTs
(Medical Device Development Tools), which were previously tracked as
``Informational Meetings'' Q-Submissions, are now tracked separately.
Dated: July 8, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-13050 Filed 7-11-25; 8:45 am]
BILLING CODE 4164-01-P
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