Anonymous,
Candy is correct - the package of user fee bills for 2022-2027 (starting Oct 1, 2022 - the start of the federal fiscal year) just passed on Sep 30, so FDA is likely catching up after that went through. On that note - the Federal Register notices for the new user fees are going to be published tomorrow - here is the MDUFA one.
Hopefully FDA will get the internal systems up and running very promptly (especially given that the user fee bills were essentially unchanged from earlier drafts). Good luck!
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Jonathan Amaya-Hodges
Director, Technical Services
Sharon MA
United States
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Original Message:
Sent: 05-Oct-2022 06:33
From: Candy Beck
Subject: Can't pay FDA MDUFA Establishment Registration Fees?
I emailed userfees about this yesterday. They responded that since the fees were just approved Sep 30 there was a delay but they expect it to be up and running by the end of the week.
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Candy Beck RAC
Regulatory Specialist
Ringwood NJ
United States
Original Message:
Sent: 04-Oct-2022 15:08
From: Anonymous Member
Subject: Can't pay FDA MDUFA Establishment Registration Fees?
This message was posted by a user wishing to remain anonymous
What's the most recent news on MDUFA V?
When I log into the User Fees website, there's no option for my MFUDA Establishment registration.
https://www.raps.org/news-and-articles/news-articles/2022/3/mdufa-v-we-have-a-deal This article appears to say they have a deal and this article: https://www.fda.gov/industry/medical-device-user-fee-amendments-mdufa/medical-device-user-fee-amendments-2023-mdufa-v appears to be last updated on 6/2022. Did they reach a decision?? Why can't see my establishment registration cover page or any cover pages from MDUFA at https://userfees.fda.gov/OA_HTML/mdufmaCAcdLogin.jsp?legalsel=2&ref= ?