FDA Registration Fees 2023 — Historical Reference

Historical reference for 2023 FDA medical device and OTC drug registration fees. For current fees, see FDA Fees 2026.

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FY 2023 - FDA Medical Device Registration Fees

FDA Medical Device Establishment registration fee for the year 2023 is USD 6,493. FDA fiscal year 2023 starts on October 1, 2022, and ends on September 30, 2023. The annual establishment registration fee must be paid between October 1, 2022, and December 31, 2022. The establishment registration fee is not eligible for a reduced small business fee.

FDA Fees for Medical Device Registration and Applications for Fiscal Year 2023

Type of Registration / Application	Standard Fees	Small Business Fee
Medical Device Establishment Registration	$6,493	$6,493
FDA 510(k) Submission	$19,870	$4,967
FDA 513(g) Submission	$5,961	$2,980
FDA PMA, PDP, PMR, BLA Submission	$441,547	$110,387
De Novo Classification Request	$132,464	$33,116
Panel-track Supplement	$353,238	$88,309
180-Day Supplement	$66,232	$16,558
Real-Time Supplement	$30,908	$7,727
BLA Efficacy Supplement	$441,547	$110,387
30-Day Notice	$7,065	$3,532
Premarket report	$441,547	$110,387
Annual Fee for Periodic Reporting on a Class III device (PMAs, PDPs, and PMRs)	$15,454	$3,864

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.