FY 2021 - FDA Medical Device Registration Fees

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.

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