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  5. Virtual Public Meeting - Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027 - 10/27/2020 - 10/27/2020
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Meeting

Event Title
Virtual Public Meeting - Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027
October 27, 2020

Date:
October 27, 2020
Time:
9:00 AM - 2:30 PM ET

The U.S. Food and Drug Administration (FDA) announced a public meeting on the reauthorization of the Medical Device User Fee Amendments for fiscal years 2023 through 2027 (MDUFA V). The current legislative authority for the medical device user fee program expires on September 30, 2022. New legislation is required for the FDA to continue to collect user fees for the medical device program in future fiscal years.

The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that before the FDA begins negotiations with the regulated industry on MDUFA reauthorization, we must take the following steps:

  • Publish a notice in the Federal Register requesting public input on the reauthorization,
  • Hold a public meeting at which the public may present its views on the reauthorization,
  • Provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes to MDUFA, and
  • Publish the comments on the FDA’s website. 

The FDA invited public comment on four specific questions related to the medical device user fee program and the commitments the FDA should propose for the next reauthorized program.

DATE AND TIME OF PUBLIC MEETING

October 27, 2020: The public meeting took place by webcast from 9 a.m. to 2:30 p.m. ET.
September 28, 2020: Registration to request to speak

WEBCAST LINK

Internet Explorer and Firefox are the preferred web browsers to view this webcast.

AGENDA

The FDA videotaped several presentations and had made them available prior to the meeting:

  • Introduction to the FDA’s MDUFA IV Accomplishments
  • MDUFA IV Performance Update
  • Building a Sustainable Infrastructure
  • Using Real-World and Postmarket Data for Regulatory Decision Making
  • Patient Engagement and the Science of Patient Input
  • Digital Health Program Update 

View Videos

Public Meeting on Medical Device User Fee Act (MDUFA) Reauthorization - October 27, 2020 
9:00 a.m.

Welcome and Introduction
Lauren Roth, J.D.
Associate Commissioner for Policy

Opening Remarks
Stephen Hahn, M.D.
Commissioner of Food and Drugs

CDRH Update
Jeff Shuren, M.D., J.D.
Director, Center for Devices and Radiological Health

CBER Update
Peter Marks, M.D., Ph.D.
Director, Center for Biologics Evaluation and Research
9:40 a.m. Perspectives on the National Evaluation System for health Technology (NEST)
  • Pamela Goldberg, M.B.A.
    President and CEO, Medical Device Innovation Consortium
  • Flora Sandra Siami, M.P.H.
    Senior Vice President, NESTcc
10:15 a.m.

Industry Perspectives

  • Janet Trunzo, M.S.
    Senior Advisor to the President and Senior Executive Vice President, Technology & Regulatory Affairs, AdvaMed
  • Mark Leahey, J.D., M.B.A.
    President and Chief Executive Officer, Medical Device Manufacturers Association
  • Peter Weems
    Director of Policy and Strategy, Medical Imaging & Technology Alliance
  • Thomas Sparkman, R.Ph., J.D., M.P.P.
    Senior Vice President for Government Affairs and Policy, American Clinical Laboratory Association
11:15 a.m. Break
11:30 a.m.

Scientific, Academic, and Health Care Professional Perspectives

  • Kathleen Blake, M.D.
    Vice President of Healthcare Quality, American Medical Association
  • Elizabeth Richardson, M.P.P.
    Project Director, Health Care Products, Pew Charitable Trusts
12:00 p.m Lunch Break
12:30 p.m.

Patient and Consumer Perspectives

  • Jeff Allen, Ph.D.
    President & Chief Executive Officer, Friends of Cancer Research
  • Brenda Huneycutt, Ph.D., J.D., M.P.H.
    Director, FasterCures
  • Michael Abrams, M.P.H., Ph.D.
    Health Researcher, Public Citizen
  • Michael Ward, M.S.
    Director of Public Policy, Alliance for Aging Research
  • Diana Zuckerman, Ph.D.
    President, National Center for Health Research
  • Paul T. Conway
    Chair, Policy & Global Affairs, American Association of Kidney Patients
  • Leanne West
    Chief Engineer Pediatric Technologies, Georgia Institute of Technology
    President, International Children’s Advisory Network
1:45 p.m. Open Public Comment Period
2:30 p.m. Closing Remarks

REGISTRATION

Registration is closed as of October 23, 2020.

HOW TO REQUEST TO PRESENT AT THE PUBLIC MEETING

During online registration, you may indicate if you wish to present during a public comment session, and which specific question you wish to address. We will do our best to accommodate requests to make public comments. Individuals and organizations with responses to the same questions or have common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation, or submit requests for designated representatives to participate in the focused sessions.

Requests to make oral presentations must be received by the close of registration on September 28, 2020 at 4:00 p.m. (ET), and any presentation materials must be emailed to Ellen Olson (see CONTACT) no later than October 20, 2020.

Following the close of registration for participating as a speaker at the meeting, we will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin and will select and notify participants by October 16, 2020. No commercial or promotional material will be permitted to be presented or distributed at the public meeting.

COMMENT TO THE DOCKET

The FDA sought comments to four specific questions related to  the current medical device user fee program and the commitments FDA should propose for the next reauthorized program https://www.regulations.gov/, Docket No. FDA-2020-N-0907. Additionally, any other pertinent information that stakeholders would like to share is welcomed by November 27, 2020.  

All comments received are available at: https://www.regulations.gov/docket/FDA-2020-N-0907

The FDA will consider discussions from the meeting and comments received in the docket.

The meeting transcript is now available in the Docket and accessible at http://www.regulations.gov.

CONTACT

For questions about the meeting’s content, please contact:

Ellen Olson
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave.
Bldg. 66, Rm. 1664
Silver Spring, MD 20993
301-796-4322
[email protected]

MDUFA V PRESENTATIONS AND TRANSCRIPT

Full Transcript

Perspectives on the National Evaluation System for health Technology (NEST)

Scientific, Academic, and Health Care Professional Perspectives:

Patient and Consumer Perspectives:

Open Public Comment Period:

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