Hello Sebastian,
What James said ... if you make a 510(k) submission after October 1st will be sent back to the company and then will have to make a new User Fee application. It does not necessarily affect the 510(k) itself, but can put on hold if the User Fee is not paid in a timely manner. In my experience, don't do it - planning submissions around October 1st need to be done strategically to avoid said situation.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 04-Mar-2023 09:05
From: James Bonds
Subject: User Fee payment timing - pay fee before price increase
Hello Sebastian,
Simply put, the FDA will not accept a "pre-pay" of the user fee. FDA states that any user fee paid that has been paid but for which there is no submission as of October 1 (new fiscal year), the user fee will be refunded and a user fee at the current rate will have to be paid at the current FY rate before a submission will be accepted.
Regards,
James
Original Message:
Sent: 3/3/2023 12:44:00 PM
From: Sebastian Feye
Subject: User Fee payment timing - pay fee before price increase
Hello,
I wanted to ask if there is any risk or any issue with paying for a user fee say in September 2023 and then submitting the 510(k) or other premarket submission in October or November 2023 after the user fees have adjusted and increased? I cannot find any guidance or reason against this method, has anyone tried this?
Thank you very much for your assistance,
Sebastian
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Sebastian Feye
San Diego CA
United States
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