FY 2022 - FDA Medical Device Registration Fees

FDA Fees FY 2023

FDA Medical Device Establishment registration fee for the year 2022 is USD 5,672. FDA fiscal year 2022 starts on October 1, 2021, and ends on September 30, 2022. The annual establishment registration fee must be paid between October 1, 2021, and December 31, 2021.

FDA Fees for Medical Device Registration and Applications for Fiscal Year 2022

Type of Registration / Application

Standard Fees

Small Business Fee

Medical Device Establishment Registration

$5,672

$5,672

FDA 510(k) Submission

$12,745

$3,186

FDA 513(g) Submission

$5,061

$2,530

FDA PMA, PDP, PMR, BLA Submission

$374,858

$93,714

De Novo Classification Request

$112,457

$28,114

Panel-track Supplement

$281,143

$70,286

180-Day Supplement

$56,229

$14,057

Real-Time Supplement

$26,240

$6,560

BLA Efficacy Supplement

$374,858

$93,714

30-Day Notice

$5,998

$2,999

Premarket report

$374,858

$93,714

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

$13,120

$3,280

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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