Meeting
Event Title
Public Meeting - Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027
April 19, 2022
- Date:
- April 19, 2022
The U.S. Food and Drug Administration (FDA) is announcing a virtual public meeting to discuss proposed recommendations for the reauthorization of the Medical Device User Fee Amendments (MDUFA) for fiscal years 2023 through 2027. MDUFA authorizes the FDA to collect fees and use them for the process for the review of device applications. The current statutory authority for MDUFA expires on September 30, 2022, and new legislation will be required for the FDA to continue collecting user fees for the medical device program in future fiscal years.
Following negotiations with the device industry and periodic consultations with public stakeholders, the Federal Food, Drug, and Cosmetic Act (the FD&C Act) directs the FDA to:
- publish the recommendations for the reauthorized program in the Federal Register
- provide for a period of 30 days for the public to provide written comments on such recommendations
- hold a meeting at which the public may present its views on such recommendations
The FDA will then consider such public views and comments and revise such recommendations as necessary.
- Federal Register Notice
- Date and Time of Public Meeting
- Webcast Link
- Agenda
- Registration
- How to Request to Present at the Public Meeting
- Comments to the Docket
- Contact
The commitment letter is posted in the docket and on this website at: https://www.fda.gov/industry/medical-device-user-fee-amendments-mdufa/medical-device-user-fee-amendments-2023-mdufa-v.
DATE, TIME and LOCATION
This meeting will be held on April 19, 2022, from 12:00 to 4:30 p.m. ET by webcast only.
WEBCAST LINK
Chrome is the preferred web browser to view this webcast.
MEETING AGENDA
Time | Topic |
---|---|
12:00 p.m. |
Welcome and Introduction |
12:05 p.m. |
FDA Opening Remarks Dr. Jeff Shuren, FDA Dr. Peter Marks, FDA |
12:15 p.m. |
FDA Remarks Lauren Roth, FDA Dr. Michelle Tarver, Center for Devices and Radiological Health, FDA Melissa Torres, Center for Devices and Radiological Health, FDA Dr. Felipe Aguel, Center for Devices and Radiological Health, FDA Kathryn Capanna, Center for Devices and Radiological Health, FDA Brendan O’Leary, Center for Devices and Radiological Health, FDA |
1:15 p.m. |
Industry Perspectives Janet Trunzo, Advanced Medical Technology Association (AdvaMed) Mark Leahey, Medical Device Manufacturers Association (MDMA) Peter Weems, Medical Imaging & Technology Alliance (MITA) Thomas Sparkman, American Clinical Laboratory Association (ACLA) |
2:00 p.m. | Break |
2:15 p.m. |
Patient, Consumer, Scientific, Academic and Health Professional Perspectives Patient, Consumer, Scientific, Academic and Health Professional Perspectives Elizabeth Richardson, The Pew Charitable Trusts Dr. S. Raymond Golish, American Academy of Orthopaedic Surgeons Jennifer Dexter, National Health Council Cynthia Bens, Personalized Medicine Coalition Dr. Michael Abrams, Public Citizen Paul Conway, American Association of Kidney Patients Amy Ohmer, International Children’s Advisory Network (iCAN) Dylan Simon, EveryLife Foundation for Rare Diseases Paul Melmeyer, Muscular Dystrophy Association |
3:30 p.m. | Open Public Comment |
4:00 p.m. | Q&A Discussion |
4:25 p.m. | Closing Comments |
REGISTRATION
If you wish to attend this meeting, you must register by 4:00 p.m. ET on April 18, 2022. There is no fee to register for the meeting.
Registrants will receive confirmation when requests for participation have been accepted, if applicable.
If you require special accommodations due to a disability, or need additional information regarding registration, please contact Susan Monahan, Office of Communication and Education, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 32, Silver Spring, MD 20993, 240-205-2260, Susan.monahan@fda.hhs.gov no later than April 11, 2022.
REQUESTS TO PRESENT
This meeting includes a public comment session and topic-focused sessions. During online registration you may indicate if you wish to present during the public comment session or a specific session, and which topic(s) you wish to address. All requests to make oral presentations must be received by April 11, 2022, at 4 p.m. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations and request time for a joint presentation. FDA will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin and will notify speakers by April 12, 2022. If selected for presentation, any presentation materials must be emailed to Mimi Nguyen (see FOR FURTHER INFORMATION CONTACT) no later than April 13, 2022, at 4:00 p.m. No commercial or promotional material will be permitted to be presented or distributed at the meeting.
COMMENTS
Please submit your comments regarding FDA’s recommendations for MDUFA reauthorization for the draft commitment letter to https://www.regulations.gov/, Docket No. FDA-2020-N-0907 by April 21, 2022.
The resulting discussions from the meeting and comments received in the docket will be taken into consideration.
Please be advised that as soon as a transcript is available, it will be posted in the Dockets and accessible at http://www.regulations.gov.
CONTACT
For questions regarding meeting content please contact:
Mimi Nguyen
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave.
Bldg. 66, Rm. 5547
Silver Spring, MD 20993
MDUFAVReauthorization@fda.hhs.gov
301-796-4125
Event Materials
Title | File Type/Size |
---|---|
Transcript: Public Meeting - MDUFA V Reauthorization - April 19, 2022 | pdf (942.48 KB) |
Amy Ohmer, Director iCAN - MDUFA Meeting 04-19-2022 Presentation | pptx (5.00 MB) |
Paul T. Conway, Chair, Policy & Global Affairs AAKP - MDUFA Meeting 04-19-2022 Presentation | pptx (1.86 MB) |