Regulatory Open Forum

Hello All-

The 2023 fees have gone up substantially from last year ( especially the 510(k) fee!). Do you think that we can expect a similar jump next year because of general inflation, or is this a result of going from MDUFA IV to MDUFA V, and next year should be less of an increase? Interested to hear your thoughts.

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Julia Anastas
San Carlos CA
United States
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Hi Julia,

It would be great if fees would go down, but I do not think that would ever happen.  In the years since they introduced MDUFMA (or whichever acronym it was at the time haha), the fees have gone up a little or a lot from year-to-year.  Personally I think there are just way too many factors to look at when the fees are involved: inflation, salaries, electricity, Congress, inflation, etc. etc.  Plus the FDA does have many electronic systems including the new electronic 510(k) submission system which has to be looked after.  The next couple years I think will be larger increases because of that, but also because of the world we live in today with the costs of everything getting a bit out of control.

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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 10-Oct-2022 13:02
From: Julia Anastas
Subject: MDUFA Fees

Hello All-

The 2023 fees have gone up substantially from last year ( especially the 510(k) fee!). Do you think that we can expect a similar jump next year because of general inflation, or is this a result of going from MDUFA IV to MDUFA V, and next year should be less of an increase? Interested to hear your thoughts.

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Julia Anastas
San Carlos CA
United States
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Hi Julia,
The big jump is in year one, and is a result of going from MDUFA IV to V. The increases in years 2 - 5 are more incremental.

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Shannon Bennett
Director of Regulatory Affairs
Rochester MN
United States
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Original Message:
Sent: 10-Oct-2022 13:02
From: Julia Anastas
Subject: MDUFA Fees

Hello All-

The 2023 fees have gone up substantially from last year ( especially the 510(k) fee!). Do you think that we can expect a similar jump next year because of general inflation, or is this a result of going from MDUFA IV to MDUFA V, and next year should be less of an increase? Interested to hear your thoughts.

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Julia Anastas
San Carlos CA
United States
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It is interesting to understand how Congress sets the fees. It is more complicated than is worthy of this short explanation. You can read the law at https://uscode.house.gov/view.xhtml?req=(title:21%20section:379j%20edition:prelim)

 

Congress sets the fees for premarket applications and establishment registration year by year. Congress also sets the total revenue FDA should receive from device user fees. The law includes formulas for adjustments including inflation, volume, and performance. Each year FDA calculates the adjustments, calculates the fee structure, and publishes it in the Federal Register.

 

For a premarket notification (510(k)), the fee is 4.5% of the fee for a premarket application (PMA). This is up from 3.4% in the previous MDUFA.

 

The Premarket Application fees for the current MDUFA are:

FY2023           $425,000

FY2024           $435,000

FY2025           $445,000

FY2026           $455,000

FY2027           $470,000

 

Understanding the fee schedule, one could estimate the 510(k) application costs. Notice the jump in FY2027 compared to other years. Based on the adjustments, the PMA fees could go up or down and take the 510(k) with them. I expect up.

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Dan O'Leary CQA, CQE
Swanzey NH
United States
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Original Message:
Sent: 10-Oct-2022 13:02
From: Julia Anastas
Subject: MDUFA Fees

Hello All-

The 2023 fees have gone up substantially from last year ( especially the 510(k) fee!). Do you think that we can expect a similar jump next year because of general inflation, or is this a result of going from MDUFA IV to MDUFA V, and next year should be less of an increase? Interested to hear your thoughts.

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Julia Anastas
San Carlos CA
United States
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