Small Business Determination
A Small Business Determination is FDA's formal finding that a company qualifies for reduced user fees. A qualified small business pays $7,163 for a 510(k) from 1 October 2026 instead of $28,653. There is no fee to apply. The saving on a single 510(k) is $21,490.
FD&C Act 738; FDA SBD guidance, 31 July 2025
At a glance
| Threshold | Gross receipts or sales of no more than $100 million for the most recent tax year, including all affiliates. |
|---|---|
| The form | FDA Form 3602N. One combined form for domestic and foreign firms. |
| Cost to apply | None. |
| What foreign firms add | A National Taxing Authority Certification, bearing the official seal of the taxing authority of the country where the business is headquartered. |
| FDA processing time | Within 60 calendar days of receipt. |
| When it expires | 30 September of the fiscal year in which it was granted. It must be re-applied for every year. |
| When it starts | On the date of FDA's decision letter, not the date you applied. |
| Does it cover registration? | No. There is no reduced establishment registration fee. |
| Is it transferable? | No. A consultant filing on your behalf cannot use its own determination. |
The National Taxing Authority Certification
A domestic firm files a signed copy of its federal income tax return. A firm headquartered outside the United States cannot, so FDA requires a certification from its national taxing authority instead. FDA sets five requirements for it.
- It must be in English.
- It must come from the National Taxing Authority of the country in which the business is headquartered.
- It must state gross receipts or sales for the most recent year, in both the local currency and in US dollars, and the exchange rate used.
- It must state the dates during which those receipts or sales were collected.
- It must bear the official seal of the National Taxing Authority.
Affiliates count. Gross receipts of all affiliates are added to yours, and the total must be no more than $100 million. A US company with a foreign affiliate must obtain a National Taxing Authority Certification for that affiliate.
Obtaining a sealed certification from a national tax office is not a same-week task in most jurisdictions. It is the step that determines how early the process must begin.
The saving, by submission type
| Submission | FY2027 standard | FY2027 small business | You save |
|---|---|---|---|
| 510(k) | $28,653 | $7,163 | $21,490 |
| 513(g) classification request | $8,596 | $4,298 | $4,298 |
| De Novo request | $191,020 | $47,755 | $143,265 |
| PMA | $636,732 | $159,183 | $477,549 |
| 30-day notice | $10,188 | $5,094 | $5,094 |
| Annual report (Class III) | $22,286 | $5,572 | $16,714 |
A separate and much lower threshold exists for the establishment registration fee: a hardship waiver at $1 million or less in gross receipts including affiliates, with proof of prior-year payment and demonstrated financial hardship. The window for that runs 1 August to 31 October.
Questions people ask
We are a startup with no revenue. Do we qualify?
If gross receipts or sales including all affiliates are no more than $100 million for the most recent tax year, yes. There is no minimum. A company at or below $30 million including affiliates may additionally qualify for a waiver of the fee on its first premarket application — PMA, PDP or BLA — or premarket report.
Does the determination carry over to next year?
No. Status expires on 30 September of the fiscal year in which it was granted, and a new request must be submitted and approved each year.
Our consultant has a small business determination. Can we use it?
No. A determination is not transferable. The applicant on the submission is the party whose status counts.
How is the request submitted?
Electronically through the CDRH Portal. Electronic submission has been mandatory since 1 November 2024.
Does it reduce the establishment registration fee?
No. FDA states the establishment registration fee is not eligible for a reduced small business fee. Every establishment pays $13,785 from 1 October 2026.