September 15, 2020 Blog Post
Virtual Public Meeting - Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027Date: October 27, 2020Time : 9:00 AM - 2:00 PM ET The U.S. Food and Drug Administration (FDA) is announcing a public meeting on the re-authorization 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 re-authorization, we must take the following steps:
Publish a notice in the Federal Register requesting public input on the re-authorization,
Hold a public meeting at which the public may present its views on the re-authorization,
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.
DATE AND TIME OF PUBLIC MEETING
October 27, 2020: The public meeting will take place by webcast from 9 a.m. to 2 p.m. ET. September 28, 2020: Registration to request to speak
WEBCAST LINK The webcast link will be available after October 13, 2020.
AGENDA The FDA will make the agenda for the public meeting available by October 13, 2020.
REGISTRATION If you wish to participate as a speaker at the meeting, you must register by 4:00 p.m. (ET) on September 28, 2020. For general attendance, registration will remain open through October 26, 2020.
As always, thanks for reading! Stay safe and be well!
Thoughts? Please comment below … Cheers! Melita Ball CEO and Principal Consultant