FDA Registration Fees 2021 — Historical Reference | LMG

Historical reference for 2021 FDA medical device and OTC drug registration fees. For current fees, see FDA Fees 2026.

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FDA Fees FY 2021

FDA Medical Device Establishment registration fee for the year 2021 is USD 5546. FDA fiscal year 2021 starts from October 1, 2020 and ends at September 30, 2021. Annual establishment registration fee must be paid between October 1, 2020 and December 31, 2020.

FDA Fees for Medical Device Registration and Applications for Fiscal Year 2021

Type of Registration / Application	Standard Fees	Small Business Fee
Medical Device Establishment Registration	$5,546	$5,546
FDA 510(k) Submission	$12,432	$3,108
FDA 513(g) Submission	$4,936	$2,468
FDA PMA, PDP, PMR, BLA Submission	$365,657	$91,414
De Novo Classification Request	$109,697	$27,424
Panel-track Supplement	$274,243	$68,561
180-Day Supplement	$54,849	$13,712
Real-Time Supplement	$25,596	$6,399
BLA Efficacy Supplement	$365,657	$91,414
30-Day Notice	$5,851	$2,926
Annual Fee for Periodic Reporting on a Class III device (PMAs, PDPs, and PMRs)	$12,798	$3,200

FDA define 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.