The FDA Small Business Determination program lets a medical device company pay a fraction of the standard user fees on premarket submissions once it proves its combined revenue with all affiliates falls under statutory thresholds. For fiscal year 2026, a qualifying firm pays $144,818 instead of $579,272 for a premarket approval application, and $6,517 instead of $26,067 for a 510(k).1Federal Register. Medical Device User Fee Rates for Fiscal Year 2026 Qualification hinges on three revenue tiers, the FDA’s broad definition of “affiliate,” and a filing process that now runs entirely online and must finish before your device submission goes in.
The Three Revenue Tiers
The Medical Device User Fee Amendments set three separate small business categories, each measured by total gross receipts or sales, including every affiliate, on the most recent tax year.2Office of the Law Revision Counsel. 21 US Code 379j – Authority to Assess and Use Device Fees
Under $100 million. The main tier. The reduction is 75 percent off standard rates for PMAs, PMA supplements, periodic reporting, De Novo classification requests, and 510(k) notifications, and 50 percent off for 30-day notices and 513(g) classification requests.2Office of the Law Revision Counsel. 21 US Code 379j – Authority to Assess and Use Device Fees
Under $30 million. A one-time complete waiver of the user fee on the company’s first PMA, biologics license application, product development protocol, or premarket report. The waiver is a single opportunity across the entire corporate family. If any affiliate has already used it, it’s gone.3U.S. Food and Drug Administration. Reduced or Waived Medical Device User Fees: Small Business Determination (SBD) Program
Under $1 million. Possible waiver of the annual establishment registration fee, but only if the business also demonstrates financial hardship and can show it paid the registration fee in a prior fiscal year. All three conditions must be met.3U.S. Food and Drug Administration. Reduced or Waived Medical Device User Fees: Small Business Determination (SBD) Program
The tiers stack. A company with $25 million in combined gross receipts qualifies at the $100 million tier for reduced rates and at the $30 million tier for the first-time PMA waiver at the same time.
What You Actually Pay for FY 2026
Fiscal year 2026 runs from October 1, 2025 through September 30, 2026. Standard and small business rates for the most common submissions:1Federal Register. Medical Device User Fee Rates for Fiscal Year 2026
- Premarket Approval Application (PMA): $579,272 standard, $144,818 small business
- 510(k) Premarket Notification: $26,067 standard, $6,517 small business
- De Novo Classification Request: $173,782 standard, $43,446 small business
- Annual Establishment Registration: $11,423, with a waiver available for qualifying sub-$1 million businesses4U.S. Food and Drug Administration. Medical Device User Fee Amendments (MDUFA) Fees
A first-time PMA from a company under $30 million costs nothing instead of $579,272. Even a single 510(k) at the top tier saves close to $19,500.
How Affiliate Revenue Is Counted
This is where most disqualifications happen. The statute defines an affiliate as any business entity that directly or indirectly controls the applicant, is controlled by the applicant, or is under the control of a common third party.5Office of the Law Revision Counsel. 21 US Code 379i – Definitions The FDA then adds every domestic and foreign affiliate’s gross receipts to the applicant’s own when measuring against the thresholds.3U.S. Food and Drug Administration. Reduced or Waived Medical Device User Fees: Small Business Determination (SBD) Program
Control does not have to be exercised. The power to control is enough. A parent that owns a majority of voting stock controls the applicant even if it never touches operations. Indirect control counts the same way: if a venture capital firm holds controlling positions in your company and in another portfolio company, both are affiliates for this program. Founders whose company looks small on its own often cross a threshold once revenue from a parent or a sister entity gets pulled in.
Filing the Small Business Request
Domestic companies use Form 3602. Foreign companies use Form 3602A. Both go through the CDRH Portal. As of November 2024, the FDA no longer accepts paper submissions for this program, and both ink and valid digital signatures are acceptable.6U.S. Food and Drug Administration. Transcript of How to Complete Form 3602
The form asks for the applicant’s legal name, address, and Taxpayer Identification Number (the EIN for U.S. businesses), then a list of every affiliate with each entity’s gross receipts from its most recent federal tax return. The form allows up to 15 affiliates.6U.S. Food and Drug Administration. Transcript of How to Complete Form 3602 The revenue figure for each entity must match its return exactly; for a corporation, that means Line 1c of Form 1120 (or the equivalent line on the return type actually filed).7Internal Revenue Service. Form 1120 – US Corporation Income Tax Return
Attach a complete, signed copy of the most recent federal income tax return for the applicant and for each affiliate. If the group filed a consolidated return, include a breakdown showing revenue by entity. Unsigned or incomplete returns are one of the more common reasons applications stall.6U.S. Food and Drug Administration. Transcript of How to Complete Form 3602
A U.S. business that has not yet filed a federal return cannot qualify. There is no substitute — audited financial statements will not be accepted in place of a return. A company that has been operating less than a year still needs a return covering its short period of operation, plus documentation of its formation date to explain the abbreviated filing.3U.S. Food and Drug Administration. Reduced or Waived Medical Device User Fees: Small Business Determination (SBD) Program
Foreign Applicants: The National Taxing Authority Step
Form 3602A carries a section the applicant cannot complete on its own. The National Taxing Authority in the applicant’s country — the government agency that administers national income tax — must fill in Section III, verifying reported gross receipts in local currency and U.S. dollars, providing the exchange rate used, and confirming it is not aware of affiliates beyond those listed.8RegInfo.gov. Form FDA 3602A Instructions A taxing authority official must sign, date, and affix an official seal before returning it. Everything in that section must be in English.9U.S. Food and Drug Administration. Transcript of How to Complete Form FDA 3602A
If your taxing authority refuses to provide the certification, submit a written explanation with documentation of the refusal, in English. If your country has no national taxing authority at all, the FDA may accept end-of-fiscal-year financial statements or shareholder reports case by case.3U.S. Food and Drug Administration. Reduced or Waived Medical Device User Fees: Small Business Determination (SBD) Program Any U.S. affiliates still need to supply their EINs and U.S. tax returns under the domestic rules.10U.S. Food and Drug Administration. Transcript of How to Complete Form FDA 3602A
Timing and Annual Renewal
Small business status expires on September 30 of the fiscal year in which it was granted. It does not carry over, and the FDA will not honor expired certifications for submissions received after that date. Requalification is required every fiscal year.3U.S. Food and Drug Administration. Reduced or Waived Medical Device User Fees: Small Business Determination (SBD) Program
The FDA begins accepting renewal requests on August 1 preceding the new fiscal year. Starting with FY 2026, applications must be filed by July 31, sixty days before the fiscal year begins on October 1. File early. You need your Small Business Decision number in hand before you submit any device application that carries a user fee. If your premarket submission arrives before the FDA has issued that decision, you pay the full standard fee and the agency will not refund the difference.3U.S. Food and Drug Administration. Reduced or Waived Medical Device User Fees: Small Business Determination (SBD) Program
The Small Business Decision letter includes a unique identifier. Reference it on every fee-bearing submission, and make sure the company name and Organization ID on the letter match the device submission exactly. A mismatch blocks the reduced rate from applying.
Mistakes That Forfeit the Savings
The most expensive one is timing. Submitting a premarket application before receiving your Small Business Decision number costs the full standard fee with no refund. On a PMA, that’s $434,454 gone.3U.S. Food and Drug Administration. Reduced or Waived Medical Device User Fees: Small Business Determination (SBD) Program
Others that come up regularly:
- Incomplete or unsigned tax returns for the applicant or any affiliate.
- Undisclosed affiliates. Leaving out an entity whose revenue would push the combined total over a threshold doesn’t only cause denial; it undercuts the credibility of the whole filing.
- Assuming status transfers after an acquisition. It doesn’t. The acquiring entity must obtain its own determination, and a buyer’s existing certification does not extend to newly acquired subsidiaries.
- A regulatory consultant claiming the reduction. Only the firm listed as the applicant on the device submission can qualify.3U.S. Food and Drug Administration. Reduced or Waived Medical Device User Fees: Small Business Determination (SBD) Program
- Name or Organization ID discrepancies between the decision letter and the premarket submission. Even a legal name abbreviation or a different address can block the fee reduction.
For foreign applicants, missing the National Taxing Authority certification on Form 3602A is a separate but equally fatal problem. Without it, the FDA cannot verify reported revenue, and the application does not move forward.