FY 2024 - FDA Medical Device Registration Fees

FDA Medical Device Establishment registration fee for the year 2024 is USD 7,653. FDA fiscal year 2024 starts on October 1, 2023, and ends on September 30, 2024. The annual establishment registration fee must be paid between October 1, 2023, and December 31, 2023. The establishment registration fee is not eligible for a reduced small business fee.

FDA Registration Fees 2024

FDA Fee for Medical Device Registration and Applications for Fiscal Year 2024

Type of Registration / Application

Standard Fees

Small Business Fee

Medical Device Establishment Registration



FDA 510(k) Submission



FDA 513(g) Submission



FDA PMA, PDP, PMR, BLA Submission



De Novo Classification Request



Panel-track Supplement



180-Day Supplement



Real-Time Supplement



BLA Efficacy Supplement



30-Day Notice



Premarket report



Annual Fee for Periodic Reporting on a Class III device (PMAs, PDPs, and PMRs)



FDA defines a small business as a business with $100 million or less in gross receipts or sales, including receipts or sales from its affiliates. In addition, if a small business has gross receipts or sales of $30 million or less, it is eligible to have the fee waived for its first PMA, PDP, PMR, or BLA.

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