Meeting

Event Title

Public Meeting - Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027

April 19, 2022

Date:: April 19, 2022
Time:: 12:00 PM - 4:30 PM ET

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.

MDUFA V virtual meeting

MEETING AGENDA

Time	Topic
12:00 p.m.	Welcome and Introduction Lauren Roth, FDA Associate Commissioner for Policy
12:05 p.m.	FDA Opening Remarks Dr. Robert Califf, FDA Commissioner of Food and Drugs Dr. Jeff Shuren, FDA Director, Center for Devices and Radiological Health Dr. Peter Marks, FDA Director, Center for Biologics Evaluation and Research
12:15 p.m.	FDA Remarks Lauren Roth, FDA Associate Commissioner for Policy Dr. Michelle Tarver, Center for Devices and Radiological Health, FDA Deputy Director, Office of Strategic Partnerships and Technology Innovation Melissa Torres, Center for Devices and Radiological Health, FDA Associate Director for International Affairs Dr. Felipe Aguel, Center for Devices and Radiological Health, FDA Deputy Director, Office of Clinical Evaluation and Analysis, Office of Product Evaluation and Quality Kathryn Capanna, Center for Devices and Radiological Health, FDA Deputy Director, Division of All Hazards Response, Science, and Strategic Partnerships, Office of Strategic Partnerships Technology Innovation Brendan O’Leary, Center for Devices and Radiological Health, FDA Acting Director, Division of Digital Health, Office of Strategic Partnerships Technology Innovation
1:15 p.m.	Industry Perspectives Janet Trunzo, Advanced Medical Technology Association (AdvaMed) Senior Executive Vice President, Technology & Regulatory Affairs Mark Leahey, Medical Device Manufacturers Association (MDMA) President and Chief Executive Officer Peter Weems, Medical Imaging & Technology Alliance (MITA) Director of Policy and Strategy Thomas Sparkman, American Clinical Laboratory Association (ACLA) Senior Vice President for Government Affairs and Policy
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 Project Director, Health Care Products Dr. S. Raymond Golish, American Academy of Orthopaedic Surgeons Jennifer Dexter, National Health Council Assistant Vice President, Policy Cynthia Bens, Personalized Medicine Coalition Senior Vice President, Public Policy Dr. Michael Abrams, Public Citizen Paul Conway, American Association of Kidney Patients Chair of Policy and Global Affairs Amy Ohmer, International Children’s Advisory Network (iCAN) Executive Director Dylan Simon, EveryLife Foundation for Rare Diseases Director, Policy Paul Melmeyer, Muscular Dystrophy Association Vice President, Public Policy & Advocacy
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, [email protected] 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
[email protected]
301-796-4125

Event Materials

Title	File Type/Size
Transcript: Public Meeting - MDUFA V Reauthorization - April 19, 2022	pdf (942.48 KB)