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  1. Medical Device User Fee Amendments (MDUFA)

Stakeholder Consultation Meetings - Medical Device User Fee Amendments 2023 (MDUFA V)

Purpose

The U.S. Food and Drug Administration (FDA) will host periodic stakeholder consultation meetings on the reauthorization of the Fiscal Years 2023 to 2027 Medical Device User Fee Amendments (MDUFA V). During these meetings, public stakeholders — including patient and consumer advocacy groups, healthcare professionals, and scientific and academic experts — can discuss their views on the MDUFA V reauthorization and provide suggestions for improving the program for consideration.

MDUFA authorizes the 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 IV) expires in September 2022. Without new legislation, the FDA will no longer be able to collect user fees for future fiscal years to fund the medical device review process.

The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that the FDA hold discussions (at least every month) with patient and consumer advocacy groups during the FDA's negotiations with the regulated industry. The purpose is to ensure continuity and progress in these monthly discussions by establishing consistent public stakeholder representation. The FDA believes that consistent stakeholder representation at these meetings will be important to ensure progress in these discussions. 

Date and Time

Note: These meetings will take place on a monthly basis. Please check this page periodically as the dates for the remaining meetings will be listed here soon.

The first stakeholder consultation meeting will be held on March 10, 2021 from 1:00 - 3:00 p.m. Eastern Time.

Webcast

This meeting will take place virtually and will be held by webcast only. Note: Meeting minutes will be captured and posted on the Medical Device User Fee Amendments 2023 (MDUFA V) page after the meeting.

How to Participate

In the Federal Register Notice, published on February 19, 2021 (86 FR 10289), the FDA requested 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 V reauthorization. Please designate one or more representatives from your organization who will commit to attending these monthly meetings and preparing for the discussions. 

Stakeholders who identify themselves to the FDA, and are otherwise eligible to attend, may participate in stakeholder consultation discussions while the FDA negotiates with the regulated industry.  

If you intend to participate in continued periodic stakeholder consultation meetings regarding MDUFA V reauthorization, please provide notification by email to MDUFAVReauthorization@fda.hhs.gov by February 26, 2021. 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. After the FDA receives the notification of intent to participate, stakeholders eligible to participate will receive confirmation and additional information about the meetings from the FDA.

Contact

If you have questions, please email them to MDUFAReauthorization@fda.hhs.gov.

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