FDA medical device user fees
FDA charges a fee for each medical device submission and for each registered establishment. The rates are set annually and published in the Federal Register, and they change on 1 October, the first day of FDA's fiscal year. Every figure on this page comes from the Federal Register notice for the year in question.
FY2026 rates 90 FR 35895; FY2027 rates 91 FR 48134, published 30 July 2026
Every fee, both years
| Submission | FY2026 standard | FY2026 small business | FY2027 standard | FY2027 small business |
|---|---|---|---|---|
| 510(k) | $26,067 | $6,517 | $28,653 | $7,163 |
| 513(g) classification request | $7,820 | $3,910 | $8,596 | $4,298 |
| De Novo request | $173,782 | $43,446 | $191,020 | $47,755 |
| PMA / PDP / PMR / BLA | $579,272 | $144,818 | $636,732 | $159,183 |
| Panel-track supplement | $463,418 | $115,855 | $509,386 | $127,347 |
| 180-day supplement | $86,891 | $21,723 | $95,510 | $23,878 |
| Real-time supplement | $40,549 | $10,137 | $44,571 | $11,143 |
| 30-day notice | $9,268 | $4,634 | $10,188 | $5,094 |
| Annual report (Class III) | $20,275 | $5,069 | $22,286 | $5,572 |
| Establishment registration | $11,423 | No reduced rate | $13,785 | No reduced rate |
The small business rate is 25 percent of the standard fee for most submission types. There are two exceptions: for a 30-day notice and for a 513(g) request, the small business rate is 50 percent.
The establishment registration fee has no small business rate. Every establishment pays the same amount, and a company paying the reduced $7,163 510(k) fee still pays the full $13,785 to register.
MDUFA V expires on 30 September 2027. FY2027 is the final year of the current authorization.
Timing decides the price
FDA must receive the correct fee at the time the application is submitted, or the application will not be accepted for filing or review.
Which fiscal year's rate applies is set by whichever comes later: the date the application reaches the reviewing center's document room, or the date the US Treasury recognizes the payment.
A 510(k) filed on 29 September 2026 with payment cleared costs $26,067. The same submission on 1 October 2026 costs $28,653. The difference is $2,586, and it turns on the later of two dates that are not entirely within the submitter's control.
Refunds, resubmissions and withdrawals
| What happened | New fee required? | FDA's wording |
|---|---|---|
| Submission refused on acceptance review (RTA) | No | Additional information may be submitted to address the refusal without a new user fee. |
| eSTAR fails technical screening | No | Same treatment as an RTA hold. |
| You withdraw before acceptance | No — refund available | You may request to withdraw and request a refund of the fee paid. |
| You withdraw after acceptance | Yes, on resubmission | No refund. The statute does not identify withdrawal under substantive review as a basis for refund. |
| Not Substantially Equivalent decision | Yes | FDA considers a further submission a new 510(k) and assesses the fee in effect at that time. |
| You miss the deadline on an Additional Information request | Yes | The submission is considered withdrawn. A new 510(k) and a new fee are required. |
| You send more information on a pending submission | No | There are no fees for additional information on a submission with no final decision yet. |
A written request for a refund must reach FDA no later than 180 days after the fee is due.
Questions people ask
Is there a fee for a Pre-Submission?
No. Q-Submissions, including Pre-Submissions, do not appear in the MDUFA fee schedule.
Is there a fee if we use a Third Party reviewer?
No FDA fee. FDA states there is no user fee for 510(k)s submitted on behalf of an FDA-accredited third-party reviewer. The third party sets and charges its own fee, paid directly to it.
Do these fees include anything besides the review?
No. The fee buys FDA's review. Testing, consulting, translation, a US Agent and establishment registration are all separate and none of them are paid to FDA.
Can a foreign company qualify for the small business rate?
Yes. The requirements differ — a foreign firm must supply a certification from its national taxing authority rather than a US tax return.
What if we cannot afford the registration fee?
A hardship waiver exists for the annual establishment registration fee, at a much lower threshold than the small business rate: gross receipts or sales of $1 million or less including affiliates, plus a demonstrated financial hardship. It is discretionary — FDA may, but is not required to, grant it — and it does not cover the initial registration. The application window runs 1 August to 31 October.