FY 2026 - FDA Medical Device Registration Fees

FDA Medical Device Establishment registration fee for the year 2026 is USD 11,423. FDA fiscal year 2026 starts on October 1, 2025, and ends on September 30, 2026. The annual establishment registration fee must be paid between October 1, 2025, and December 31, 2025. The establishment registration fee is not eligible for a reduced small business fee.

FDA Registration Fees 2026

FDA Fee for Medical Device Registration and Applications for Fiscal Year 2026

Type of Registration / Application

Standard Fees

Small Business Fee

Medical Device Establishment Registration

$11,423

$11,423

FDA 510(k) Submission

$26,067

$6,517

FDA 513(g) Submission

$7,820

$3,910

FDA PMA, PDP, PMR, BLA Submission

$579,272

$144,818

De Novo Classification Request

$173,782

$43,446

Panel-track Supplement

$463,418

$115,855

180-Day Supplement

$86,891

$21,723

Real-Time Supplement

$40,549

$10,137

BLA Efficacy Supplement

$579,272

$144,818

30-Day Notice

$9,268

$4,634

Premarket report

$579,272

$144,818

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

$20,275

$5,069

The FDA defines a small business as a business, including its affiliates, that has gross receipts or sales of no more than $100 million for the most recent tax year. 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.

FY 2026 FDA Small Business Waiver for Establishment Registration Fees

For FY 2026, the FDA may grant a waiver of the annual establishment registration fee (excluding the initial registration) to applicants qualifying as small businesses. This waiver is contingent upon the FDA's determination that the establishment is a small business and that paying the fee for that year would constitute a financial hardship. For the purpose of this waiver, a small business is defined as one with $1,000,000 or less in gross receipts or sales in the most recent Federal (U.S.) income tax return (including the returns of its affiliates).

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