Notice2025-09618
Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Guidance for Industry and Food and Drug Administration Staff; Availability
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Published
May 29, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program." This guidance document provides an overview of the mechanisms available to submitters through which they can request interactions with FDA related to medical device submissions. This guidance supersedes the document entitled "Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program" issued on June 2, 2023, and provides clarification and additional information on the scope of Q-Submission (Q-Sub) types, better delineation of how to obtain feedback for different types of questions (i.e., informal communication vs. Pre-Submission or other Q-Sub types), and improved examples.
Full Text
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<title>Federal Register, Volume 90 Issue 102 (Thursday, May 29, 2025)</title>
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[Federal Register Volume 90, Number 102 (Thursday, May 29, 2025)]
[Notices]
[Pages 22737-22739]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-09618]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-D-1774]
Requests for Feedback and Meetings for Medical Device
Submissions: The Q-Submission Program; Guidance for Industry and Food
and Drug Administration Staff; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Requests for Feedback
and Meetings for Medical Device Submissions: The Q-Submission
Program.'' This guidance document provides an overview of the
mechanisms available to submitters through which they can request
interactions with FDA related to medical device submissions. This
guidance supersedes the document entitled ``Requests for Feedback and
Meetings for Medical Device Submissions: The Q-Submission Program''
issued on June 2, 2023, and provides clarification and additional
information on the scope of Q-Submission (Q-Sub) types, better
delineation of how to obtain feedback for different types of questions
(i.e., informal communication vs. Pre-Submission or other Q-Sub types),
and improved examples.
DATES: The announcement of the guidance is published in the Federal
Register on May 29, 2025.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
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
[[Page 22738]]
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-2018-D-1774 for ``Requests for Feedback and Meetings for Medical
Device Submissions: The Q-Submission Program.'' Received comments 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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Requests for Feedback and Meetings for Medical Device Submissions:
The Q-Submission Program'' to the Office of Policy, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5441, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your request.
FOR FURTHER INFORMATION CONTACT: Erica Takai, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5456, Silver Spring, MD 20993-0002, 301-796-6353;
or James Myers, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993-0002, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
As part of the Medical Device User Fee Amendments of 2022, the
Agency committed to issuing a final guidance to provide additional
information to assist in identifying the circumstances in which an
applicant's question is most appropriate for informal communication
instead of a Pre-Submission. This final guidance reflects such
additional information and further clarifies other elements of the Q-
Sub Program.
This guidance provides an overview of the mechanisms available to
submitters through which they can request interactions with FDA,
including written feedback and/or a meeting regarding medical device
Investigational Device Exemption applications, Premarket Approval
applications, Humanitarian Device Exemption applications, De Novo
requests, 510(k) submissions, Clinical Laboratory Improvement
Amendments (CLIA) Waiver by Applications, Dual 510(k) and CLIA Waiver
by Application submissions, Accessory Classification Requests, and
certain Investigational New Drug applications and Biologics License
Applications submitted to the Center for Biologics Evaluation and
Research. FDA considered the applicability of Executive Order 14192,
per OMB guidance in M-25-20, and finds this action to be deregulatory
in nature.
A notice of availability of the draft guidance appeared in the
Federal Register of March 15, 2024 (89 FR 18947). FDA considered
comments received and revised the guidance as appropriate in response
to the comments, including expanded examples of Pre-Submission topics
and questions, and minor clarifications.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on Requests for Feedback and Meetings for
Medical Device Submissions: The Q-Submission Program. It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.
II. Electronic Access
Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at <a href="https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products">https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products</a>. This guidance document is also
available at <a href="https://www.regulations.gov">https://www.regulations.gov</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics</a>. Persons unable to download an electronic copy of
``Requests for Feedback and Meetings for Medical Device Submissions:
The Q-Submission Program'' may send an email request to <a href="/cdn-cgi/l/email-protection#befdfaecf693f9cbd7dadfd0dddbfed8dadf90d6d6cd90d9d1c8"><span class="__cf_email__" data-cfemail="7f3c3b2d3752380a161b1e111c1a3f191b1e5117170c51181009">[email protected]</span></a> to receive
[[Page 22739]]
an electronic copy of the document. Please use the document number
GUI00001677 and complete title to identify the guidance you are
requesting.
III. Paperwork Reduction Act of 1995
While this guidance contains no new collection of information, it
does refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in the following table have been approved by OMB:
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21 CFR part; guidance; or FDA OMB control
form or collection instrument Topic No.
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807, subpart E................. Premarket notification. 0910-0120
814, subparts A through E...... Premarket approval..... 0910-0231
814, subpart H................. Humanitarian Use 0910-0332
Devices; Humanitarian
Device Exemption.
812............................ Investigational Device 0910-0078
Exemption.
860, subpart D................. De Novo classification 0910-0844
process.
Form FDA 3601 ``Medical Device Medical Device User Fee 0910-0511
User Fee Cover Sheet''; form Cover Sheet and Device
FDA 3601(a), the ``Device Facility User Fee
Facility User Fee Cover Cover Sheet--Form FDA
Sheet''; ``FDA and Industry 3601 and Form 3601(a);
Procedures for Section 513(g) 513(g) Request for
Requests for Information Under Information.
the Federal Food, Drug, and
Cosmetic Act''.
``Requests for Feedback and Q-submissions and Early 0910-0756
Meetings for Medical Device Payor Feedback Request
Submissions: The Q-Submission Programs for Medical
Program''. Devices.
``Administrative Procedures for CLIA Administrative 0910-0607
CLIA Categorization'' and Procedures; CLIA
``Recommendations: Clinical Waivers.
Laboratory Improvement
Amendments of 1988 (CLIA)
Waiver Applications for
Manufacturers of In Vitro
Diagnostic Devices''.
``Medical Device Accessories-- Accessories............ 0910-0823
Describing Accessories and
Classification Pathways''.
``Center for Devices and Appeals Process........ 0910-0738
Radiological Health Appeals
Processes''.
``Authorization of Medical Emergency Use 0910-0595
Products for Use Emergencies''. Authorization.
312............................ Investigational New 0910-0014
Drug Application.
601............................ Biologics License 0910-0338
Application.
FDA's web page: Total Product TAP Pilot.............. 0910-0930
Life Cycle Advisory Program
(TAP) (<a href="https://www.fda.gov/medical-devices/how-study-and-market-your-device/total-product-life-cycle-advisory-program-tap">https://www.fda.gov/medical-devices/how-study-and-market-your-device/total-product-life-cycle-advisory-program-tap</a>).
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Dated: May 22, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-09618 Filed 5-28-25; 8:45 am]
BILLING CODE 4164-01-P
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