FDA Registration Fees 2024 — Historical Reference

Historical reference for 2024 FDA medical device and OTC drug registration fees. For current fees, see FDA Fees 2026.

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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 Fee for Medical Device Registration and Applications for Fiscal Year 2024

Type of Registration / Application	Standard Fees	Small Business Fee
Medical Device Establishment Registration	$7,653	$7,653
FDA 510(k) Submission	$21,760	$5,440
FDA 513(g) Submission	$6,528	$3,264
FDA PMA, PDP, PMR, BLA Submission	$483,560	$120,890
De Novo Classification Request	$145,068	$36,267
Panel-track Supplement	$386,848	$96,712
180-Day Supplement	$72,534	$18,134
Real-Time Supplement	$33,849	$8,462
BLA Efficacy Supplement	$483,560	$120,890
30-Day Notice	$7,737	$3,869
Premarket report	$483,560	$120,890
Annual Fee for Periodic Reporting on a Class III device (PMAs, PDPs, and PMRs)	$16,925	$4,231

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.