FDA Registration Fees 2027
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FY 2027 – FDA Medical Device Registration Fees
FDA Medical Device Establishment registration fee for the year 2027 is USD 13,785. FDA fiscal year 2027 starts on October 1, 2026, and ends on September 30, 2027. The annual establishment registration fee must be paid between October 1, 2026, and December 31, 2026. The establishment registration fee is not eligible for a reduced small business fee.
FDA Fee for Medical Device Registration and Applications for Fiscal Year 2027
| Type of Registration / Application | Standard Fees | Small Business Fee |
|---|---|---|
| Medical Device Establishment Registration | $13,785 | $13,785 |
| FDA 510(k) Submission | $28,653 | $7,163 |
| FDA 513(g) Submission | $8,596 | $4,298 |
| FDA PMA, PDP, PMR, BLA Submission | $636,732 | $159,183 |
| De Novo Classification Request | $191,020 | $47,755 |
| Panel-track Supplement | $509,386 | $127,347 |
| 180-Day Supplement | $95,510 | $23,878 |
| Real-Time Supplement | $44,571 | $11,143 |
| BLA Efficacy Supplement | $636,732 | $159,183 |
| 30-Day Notice | $10,188 | $5,094 |
| Annual Fee for Periodic Reporting on a Class III device (PMAs, PDPs, and PMRs) | $22,286 | $5,572 |
| Premarket report | $636,732 | 159,183 |
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 2027 FDA Small Business Waiver for Establishment Registration Fees
For FY 2027, 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).
Frequently Asked Questions
What is the FDA device registration fee for 2027?
Are small businesses eligible for a reduced registration fee?
No, the medical device establishment registration fee is not eligible for a small business reduction. All establishments must pay the standard fee.
How much is the 510(k) submission fee?
For Fiscal Year 2027, the standard FDA 510(k) submission fee is $28,653. (If qualified as a small business, the reduced fee is $7,163).
Are LMG service fees separate from FDA fees?
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