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 Registration Fees 2023

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.

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