Notices. Notice; request for notification of participation
786 words·~4 min read·
/register/2025/06/27/2025-11911·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4164-01-P 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. 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 *MDUFAVIReauthorization@fda.hhs.gov.* 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 *https://www.dhs.gov/real-id/real-id-faqs.* 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, *MDUFAVIReauthorization@fda.hhs.gov.* 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 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 *MDUFAVIReauthorization@fda.hhs.gov* 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]
Connectionstraces to 1
Traces to 1 document
Citation graph
cites case law
Notices
Notice; request for notification of participation
Cites 1Cited by 0 across 0 sources