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The following table shows the fees per each medical device submission type for FDA fiscal year 2022, beginning Oct 1, 2021 through September 30, 2022.  For eligibility of the reduced small business fee, gross receipts or sales (including sales or receipts from its affiliates) from the most recent tax year must be under $100 million. Also, if a small business has gross receipts or sales of or less than $30 million, they are eligible to have the fee waived for their first PMA, PDP, PMR or BLA. For more information, click the button below to the FDA application or feel free to contact us.
Finally, each establishment is required to be registered with the FDA. The FY 2022 Establishment Registration Fee is $5,672. There are no reductions or discounts for small businesses or establishments and the fee must be paid between October 1, 2021 - December 31, 2021.
1 Comment
10/6/2025 04:43:38 am
Thanks for sharing this update. The FDA's FY 2022 MDUFA user fees and establishment registration fee details are helpful for medical device companies planning their budgets. The $5,672 establishment registration fee is a fixed cost, with no discounts for small businesses. It's important to note that this fee must be paid between October 1 and December 31, 2021. For small businesses with gross receipts under $100 million, there are opportunities for reduced or waived fees for certain submissions. Companies should ensure timely payment and consider eligibility for fee reductions to manage costs effectively. Leave a Reply. |
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