Notice2025-11911
Medical Device User Fee Amendments; Stakeholder Meetings on the Medical Device User Fee Amendments of Fiscal Years 2028 to 2032 Reauthorization; Request for Notification of Stakeholder Intention To Participate
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Published
June 27, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or the Agency) is issuing this notice to request that public stakeholders--including patient and consumer advocacy groups, healthcare professionals, and scientific and academic experts--notify FDA of their intent to participate in periodic consultation meetings on the reauthorization of the Medical Device User Fee Amendments (MDUFA). The statutory authority for MDUFA expires September 30, 2027. At that time, new legislation will be required for FDA to continue collecting user fees for the medical device program. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that FDA consult with a range of stakeholders in developing recommendations for the next MDUFA program. The FD&C Act also requires that FDA hold discussions (at least every month) with patient and consumer advocacy groups during FDA's negotiations with the regulated industry. The purpose of this request for notification is to ensure continuity and progress in these monthly discussions by establishing consistent stakeholder representation.
Full Text
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<title>Federal Register, Volume 90 Issue 122 (Friday, June 27, 2025)</title>
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[Federal Register Volume 90, Number 122 (Friday, June 27, 2025)]
[Notices]
[Pages 27638-27639]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-11911]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-2253]
Medical Device User Fee Amendments; Stakeholder Meetings on the
Medical Device User Fee Amendments of Fiscal Years 2028 to 2032
Reauthorization; Request for Notification of Stakeholder Intention To
Participate
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for notification of participation.
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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
issuing this notice to request that public stakeholders--including
patient and consumer advocacy groups, healthcare professionals, and
scientific and academic experts--notify FDA of their intent to
participate in periodic consultation meetings on the reauthorization of
the Medical Device User Fee Amendments (MDUFA). The statutory authority
for MDUFA expires September 30, 2027. At that time, new legislation
will be required for FDA to continue collecting user fees for the
medical device program. The Federal Food, Drug, and Cosmetic Act (FD&C
Act) requires that FDA consult with a range of stakeholders in
developing recommendations for the next MDUFA program. The FD&C Act
also requires that FDA hold discussions (at least every month) with
patient and consumer advocacy groups during FDA's negotiations with the
regulated industry. The purpose of this request for notification is to
ensure continuity and progress in these monthly discussions by
establishing consistent stakeholder representation.
DATES: Submit notification of intention to participate in these series
of meetings on or before July 28, 2025. Stakeholder meetings will be
held monthly. It is anticipated that they will commence by October
2025. See the SUPPLEMENTARY INFORMATION section for registration date
and information.
ADDRESSES: Submit notification of intention to participate in monthly
stakeholder meetings by email to <a href="/cdn-cgi/l/email-protection#95d8d1c0d3d4c3dcc7f0f4e0e1fdfae7fceff4e1fcfafbd5f3f1f4bbfdfde6bbf2fae3"><span class="__cf_email__" data-cfemail="8cc1c8d9cacddac5dee9edf9f8e4e3fee5f6edf8e5e3e2cceae8eda2e4e4ffa2ebe3fa">[email protected]</span></a>.
The meetings will be held in person at the FDA White Oak campus, 10903
New Hampshire Ave., Silver Spring, MD 20993 and virtually using the
Microsoft Teams platform. Participants must be REAL ID compliant to
access federal facilities. For additional information regarding REAL
ID, refer to <a href="https://www.dhs.gov/real-id/real-id-faqs">https://www.dhs.gov/real-id/real-id-faqs</a>.
FOR FURTHER INFORMATION CONTACT: Nia Benjamin, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Silver Spring, MD 20993-0002, 301-796-5424,
<a href="/cdn-cgi/l/email-protection#7b363f2e3d3a2d32291e1a0e0f13140912011a0f1214153b1d1f1a55131308551c140d"><span class="__cf_email__" data-cfemail="ffb2bbaab9bea9b6ad9a9e8a8b97908d96859e8b969091bf999b9ed197978cd1989089">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is requesting that public stakeholders--including patient and
consumer advocacy groups, healthcare professionals, and scientific and
academic experts--notify the Agency of
[[Page 27639]]
their intent to participate in periodic stakeholder consultation
meetings on the reauthorization of MDUFA. MDUFA authorizes FDA to
collect user fees from the regulated industry for the process for the
review of medical devices. The authorization for the current program
(MDUFA V) expires September 30, 2027.
Section 738A(b)(1) of the FD&C Act (21 U.S.C. 379j-1(b)(1))
requires that FDA consult with a range of stakeholders, including
representatives from patient and consumer advocacy groups, healthcare
professionals, and scientific and academic experts, in developing
recommendations for the next MDUFA program. FDA will initiate the
reauthorization process by holding a public meeting on August 4, 2025,
where stakeholders and other members of the public will be given an
opportunity to present their views on the reauthorization. The FD&C Act
further requires that FDA continue meeting with the representatives of
patient and consumer advocacy groups at least once every month during
negotiations with the regulated industry to continue discussions of
stakeholder views on the reauthorization. It is anticipated that these
monthly stakeholder consultation meetings will commence by October
2025.
FDA is issuing this Federal Register notice to request that
stakeholder representatives from patient and consumer advocacy groups,
healthcare professional associations, as well as scientific and
academic experts, notify FDA of their intent to participate in the
periodic stakeholder consultation meetings on MDUFA reauthorization.
FDA believes that consistent stakeholder representation at these
meetings will be important to ensure progress in these discussions. If
you wish to participate in the stakeholder consultation meetings,
please designate one or more representatives from your organization who
will commit to attending these meetings and preparing for the
discussions. Stakeholders who identify themselves through this notice,
and are otherwise eligible to attend, may participate in all
stakeholder consultation discussions while FDA negotiates with the
regulated industry. These stakeholder discussions will satisfy the
consultation requirement in section 738A(b)(3) of the FD&C Act (21
U.S.C. 379j-1(b)(3)).
II. Notification of Intent To Participate in Periodic Stakeholder
Consultation Meetings
If you intend to participate in continued periodic stakeholder
consultation meetings regarding MDUFA reauthorization, please provide
notification by email to <a href="/cdn-cgi/l/email-protection#e5a8a1b0a3a4b3acb7808490918d8a978c9f84918c8a8ba5838184cb8d8d96cb828a93"><span class="__cf_email__" data-cfemail="1e535a4b585f48574c7b7f6b6a76716c77647f6a7771705e787a7f3076766d30797168">[email protected]</span></a> on or
before July 28, 2025. Your email should contain complete contact
information, including name, title, affiliation, address, email
address, phone number, and notice of any special accommodations
required because of disability. Stakeholders will receive confirmation
and additional information about the first meeting after FDA receives
this notification.
Dated: June 24, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-11911 Filed 6-26-25; 8:45 am]
BILLING CODE 4164-01-P
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