- October 27, 2020
9:00 AM - 2:30 PM ET
The U.S. Food and Drug Administration (FDA) is announcing 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 invites 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.
- Federal Register Notice
- Date and Time of Public Meeting
- Webcast Link
- How to Request to Present at the Public Meeting
- How to Comment
October 27, 2020: The public meeting will take place by webcast from 9 a.m. to 2:30 p.m. ET.
September 28, 2020: Registration to request to speak
The FDA videotaped several presentations and has 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
|Public Meeting on Medical Device User Fee Act (MDUFA) Reauthorization - October 27, 2020|
Welcome and Introduction
|9:40 a.m.||Perspectives on the National Evaluation System for health Technology (NEST)
Scientific, Academic, and Health Care Professional Perspectives
|12:00 p.m||Lunch Break|
Patient and Consumer Perspectives
|1:45 p.m.||Open Public Comment Period|
|2:30 p.m.||Closing Remarks|
Registration is closed as of October 23, 2020.
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.
The FDA is seeking 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.
Please refer to the Federal Register notice for the specific questions and submitting comments to the docket to ensure that your feedback is received.
The FDA will consider discussions from the meeting and comments received in the docket.
As soon as a transcript is available, it will be posted in the Dockets and accessible at http://www.regulations.gov.
For questions about the meeting’s content, please contact:
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave.
Bldg. 66, Rm. 1664
Silver Spring, MD 20993