Federal Register, Volume 90 Issue 111 (Wednesday, June 11, 2025)

[Federal Register Volume 90, Number 111 (Wednesday, June 11, 2025)]
[Notices]
[Pages 24633-24635]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-10551]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2025-N-1157]


Reauthorization of the Medical Device User Fee Amendments; Public 
Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
hosting a hybrid public meeting entitled ``Medical Device User Fee 
Amendments.'' The purpose of the public meeting is to discuss proposed 
recommendations for the reauthorization of the Medical Device User Fee 
Amendments (MDUFA) for fiscal years (FYs) 2028 through 2032. MDUFA 
authorizes FDA to collect fees and use them for the process for the 
review of device applications. The current legislative authority for 
MDUFA expires September 30, 2027. At that time, new legislation will be 
required for FDA to continue collecting device user fees in future 
fiscal years. The Federal Food, Drug, and Cosmetic Act (FD&C Act) 
directs that FDA begin reauthorization by publishing a notice in the 
Federal Register requesting public input and holding a meeting where 
the public may present its views on the reauthorization. FDA invites 
public comment as the Agency begins the process to reauthorize the 
program in FYs 2028 through 2032. These comments will be published and 
available on FDA's website.

DATES: The public meeting will be held on August 4, 2025, from 10 a.m. 
to 3 p.m. Eastern Time and will take place in-person with a webcast 
option. Submit electronic or written comments on this public meeting by 
September 4, 2025. See the SUPPLEMENTARY INFORMATION section for 
registration date and information.

ADDRESSES: The public meeting will be held in-person at the FDA White 
Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, 
the White Oak Great Room, Silver Spring, MD 20993-0002 and virtually 
using the Microsoft Teams platform. Entrance for the public meeting 
participants (non-FDA employees) is through Building 1 where routine 
security check procedures will be performed. Participants must be REAL 
ID compliant to access federal facilities. For additional information 
regarding REAL ID, refer to https://www.dhs.gov/real-id/real-id-faqs. 
For security and parking information, please refer to https://www.fda.gov/about-fda/visitor-information/public-meeting-information 
and https://www.fda.gov/about-fda/visitor-information/visitor-parking-and-campus-map.
    You may submit comments as follows. Please note that late, untimely 
filed comments will not be considered. The https://www.regulations.gov 
electronic filing system will accept comments until 11:59 p.m. Eastern 
Time on September 4, 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:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
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 https://www.regulations.gov.
     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:
     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.
     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-1157 for ``Reauthorization of the Medical Device User Fee 
Amendments; Public Meeting; Request for Comments.'' 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 https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.

[[Page 24634]]

     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 https://www.regulations.gov. 
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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov 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: Nia Benjamin, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Room 5422, Silver Spring, MD 20993-0002, 301-796-5424, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing a hybrid public meeting to begin the 
reauthorization process for MDUFA, the legislation that authorizes FDA 
to collect user fees to support the process for the review of medical 
device applications, which reaches various components in FDA, including 
the Center for Devices and Radiological Health (CDRH), the Center for 
Biologics Evaluation and Research (CBER), the Office of the 
Commissioner (OC), and the Office of Inspections and Investigations 
(OII). The current authorization of the program (MDUFA V) expires 
September 30, 2027.
    Section 738A(b)(2) of the FD&C Act (21 U.S.C. 379j-1(b)(2)) 
requires that, before FDA begins negotiations with regulated industry 
on MDUFA reauthorization, the Agency performs the following: (1) 
publish a notice in the Federal Register requesting public input on the 
reauthorization; (2) hold a public meeting where the public may present 
its views on the reauthorization; (3) provide a period of 30 days after 
the public meeting to obtain written comments from the public; and (4) 
publish the comments on FDA's website. This notice, the public meeting, 
the 30-day comment period after the meeting, and the posting of the 
comments on the FDA's website will satisfy these requirements. The 
purpose of the meeting is to hear stakeholder views on MDUFA as we 
consider the features to propose, update, discontinue, or add in the 
next MDUFA. FDA is interested in responses to the following questions 
and welcomes any other pertinent information stakeholders would like to 
share:
    (1) What is your assessment of the overall performance of MDUFA V 
thus far?
    (2) What current features of MDUFA should be reduced or 
discontinued to ensure the continued efficiency and effectiveness of 
the medical device review process?
    (3) What new features should FDA consider adding to the program to 
enhance the efficiency and effectiveness of the medical devices review 
process?
    (4) What changes, if any, could be made to the current fee 
structures and amounts to better advance the goals of the agreement, 
including facilitating product development and timely access for 
consumers?

II. Public Meeting Information

A. Purpose and Scope of the Meeting

    In general, the public meeting's format will include presentations 
by FDA and other interested parties, which may include scientific and 
academic experts, healthcare professionals, representatives of patient 
and consumer advocacy groups, the medical device industry, and the 
general public. A draft agenda and other background information for the 
public meeting will be posted at: https://www.fda.gov/medical-devices/medical-devices-news-and-events/register-fdas-public-meeting-reauthorization-medical-device-user-fee-amendments-08042025.

B. Participating in the Public Meeting

    Registration: To register for the public meeting, please visit the 
following web page: https://www.fda.gov/medical-devices/medical-devices-news-and-events/register-fdas-public-meeting-reauthorization-medical-device-user-fee-amendments-08042025. Please provide complete 
contact information for each attendee, including name, title, 
affiliation, email, and telephone number.
    Registration is free for both in-person and virtual attendance. In-
person attendance is based on space availability, with priority given 
to early registrants. Early registration is recommended because seating 
is limited; therefore, FDA may limit the number of participants from 
each organization.
    If you need special accommodations due to a disability, please 
contact [email protected] no later than July 25, 2025.
    Opportunity for Public Comment: Those who register online by June 
30, 2025, at 11:59 p.m. Eastern Time will receive a notification about 
an opportunity to participate in the public comment session of the 
meeting. If you wish to speak during the public comment session, follow 
the instructions in the notification and identify which topic(s) you 
wish to address. All requests to make public comments during the 
meeting must be received by July 7, 2025, at 11:59 p.m. Eastern Time. 
We will do our best to accommodate requests to make public comments. 
Individuals and organizations with common interests are urged to 
consolidate or coordinate comment and request time jointly. We will 
determine the amount of time allotted to each commenter, and the 
approximate time each comment is to begin, and will select and notify 
participants by July 14, 2025. No commercial or promotional material 
will be permitted to be presented at the public meeting.
    Streaming Webcast of the Public Meeting: This public meeting will 
also be webcast. The meeting web page link is: https://teams.microsoft.com/l/meetup-join/19%3ameeting_ODQ3YzUwMDEtODk3Zi00YTFhLWIwYzAtMmFjMzlkYzM5YzVh%40thread.v2/0?context=%7b%22Tid%22%3a%227d2fdb41-339c-4257-87f2-a665730b31fc%22%2c%22Oid%22%3a%22b991a8ee-e689-4dc1-bd5d-afa310d67246%22%7d.
    Transcripts: Please be advised that as soon as a transcript of the 
public meeting is available, it will be accessible at https://www.regulations.gov. It may

[[Page 24635]]

be viewed at the Dockets Management Staff (see ADDRESSES). A link to 
the transcript will also be available on the internet at: https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/public-meeting-medical-device-user-fee-amendments-fiscal-years-2023-through-2027-04192022.
    Notice of this meeting is given pursuant to 21 CFR 10.65.

    Dated: June 4, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-10551 Filed 6-10-25; 8:45 am]
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