De Novo Classification Fees in 2026: What Small Businesses Actually Pay

If you are planning a De Novo classification request, the first number most teams look up is the FDA user fee. For fiscal year 2026 it is $173,782 at the standard rate and $43,446 if you qualify as a small business. That is a difference of $130,336 on a single submission, and it is available to more companies than most founders assume.

The catch is that the discount is not automatic, it is not retroactive, and it has a hard deadline that sits 60 days before you actually file. Miss it and you pay full price on a submission you could have made for a quarter of the cost.

What the 2026 fee schedule actually says

FDA sets medical device user fees each fiscal year under the Medical Device User Fee Amendments (MDUFA). Most device fees are calculated as a percentage of the standard premarket application fee, which is $579,272 for FY2026. A De Novo classification request is set at 30 percent of that figure.

For all submissions except 30-day notices and 513(g) classification requests, the small business fee is 25 percent of the standard fee. The FY2026 numbers that matter to a device or software company:

De novo classification request: $173,782 standard, $43,446 small business. 510(k) premarket notification: $26,067 standard, $6,517 small business. Premarket approval application (PMA): $579,272 standard, $144,818 small business. 513(g) request for classification information: $7,820 standard, $3,910 small business. Annual establishment registration: $11,423, with no standard small business discount.

Note that last line. The establishment registration fee is the same for everyone, and it is annual. A pre-revenue company with one manufacturing site still pays $11,423 every year it is registered, whether or not it submits anything. FDA may grant a hardship waiver, but only for businesses with $1,000,000 or less in gross receipts, and only at its discretion.

Fees reset every 1 October, so the FY2027 figures published at the end of July will apply to anything received on or after that date. If your submission is close to the fiscal year boundary, check which schedule applies before you budget.

How you qualify as a small business

The threshold is far more generous than the phrase "small business" suggests. If your business, including all affiliates, had gross receipts or sales of no more than $100 million in the most recent tax year, you may qualify for the reduced fee. A separate and lower threshold of $30 million qualifies you for a waiver of the fee on your first premarket application, premarket report, PDP or BLA — that waiver does not cover De Novo requests, but the 75 percent reduction does.

Three points trip teams up:

Affiliates count. If a venture or strategic investor has a controlling interest, their receipts can be pulled into the calculation. Work this out before you rely on the discount in your budget.

The 60-day rule is absolute. You must submit your Small Business Request with the supporting tax documentation at least 60 days before your submission reaches FDA. If you file before FDA has found that you qualify, you pay the full fee for that submission. There is no refund and no retroactive adjustment.

Qualification is annual. Small business status is granted for a fiscal year and has to be re-established each year, with the current year's tax documentation.

Foreign applicants follow a parallel process using a national taxing authority certification rather than a US tax return, which typically takes longer to assemble. Start earlier if your parent entity is outside the US.

The costs the fee schedule does not show

The user fee is rarely the largest line in a De Novo budget. The submission itself is what costs money.

A De Novo means there is no predicate, so there is no shortcut through substantial equivalence. You are asking FDA to create a new classification regulation and write the special controls that will govern it and every follower behind you. In practice that means clinical or clinical-grade performance data, a full risk analysis tied to the proposed special controls, human factors work where use error matters, and usually one or more pre-submission meetings before you file. Our predicate device guide covers how to confirm you genuinely have no predicate before you commit to this route.

The review clock is also a cost. The MDUFA performance goal for De Novo decisions is 150 FDA days, but total elapsed time runs longer once additional information requests stop the clock. Build a burn-rate line for that period, not just a fee line. Our 510(k) vs PMA comparison sets out how the three routes differ on cost and timeline.

And there is an obligation after clearance: a granted De Novo creates the classification regulation, which means your product becomes the predicate other companies cite. Your labelling, special controls and post-market reporting are now part of a public template.

Three things to do now

Run the affiliate test first. Before anyone writes "small business fee" into a financial model, confirm that the combined gross receipts of your company and its affiliates sit under $100 million for the relevant tax year.

Put the Small Business Request on the critical path. Work backwards from your target submission date, add 60 days, and treat that as a hard milestone alongside your design freeze — not an administrative task to do at the end.

Confirm the route before you pay for it. A De Novo is the right answer only when no predicate exists and the risk profile is genuinely low to moderate. Use the FDA regulatory pathways guide and the pathway selection article to test that conclusion before the fee becomes sunk cost.

If you are running this analysis across multiple markets at once, MedTech Compass scores regulatory and reimbursement conditions across 25+ markets so the US fee decision sits in the context of the whole launch plan, and DevicePath gives you an open model for early classification triage. For reimbursement planning alongside clearance, start with the market access guide.

Sources

1. FDA — Medical Device User Fee Amendments (MDUFA): https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa 2. Federal Register — Medical Device User Fee Rates for Fiscal Year 2026: https://www.federalregister.gov/documents/2025/07/30/2025-14412/medical-device-user-fee-rates-for-fiscal-year-2026 3. FDA — Medical Device User Fee Small Business Qualification and Certification (guidance): https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-user-fee-small-business-qualification-and-certification 4. FDA — De Novo Classification Request: https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/de-novo-classification-request 5. FDA — De Novo database: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm

This article summarises public FDA fee schedules and guidance and is not legal or regulatory advice. Confirm current rates against the fiscal year notice that applies to your submission date.