Your FDA Small Business Discount Expires 30 September: The CRA Certification Canadian Device Firms Miss

If your company filed a 510(k) with a small business discount last year, that status is about to disappear. FDA medical device small business qualification does not carry over. It expires at the end of the fiscal year on 30 September 2026, and you have to earn it again for fiscal year 2027. For a Canadian firm, re-qualifying is not a matter of attaching a tax return. It requires a certification from the Canada Revenue Agency (CRA), and that step is exactly where Canadian device companies get caught.

The gap between the standard and small business fee is not small. On a single 510(k) submission in fiscal year 2027, it is USD 21,490. Miss the re-qualification and that is what you pay extra, per submission. This article explains what changes on 30 September, why the CRA certification trips up Canadian firms, and what to do now.

What changes on 30 September 2026

Direct answer: two things happen at once. Your existing small business determination lapses at the close of fiscal year 2026 on 30 September, and the new fiscal year 2027 fee rates take effect on 1 October. FDA published those rates on 30 July 2026 in the Federal Register (FR doc 2026-15335). The rates below apply from 1 October 2026 through 30 September 2027.

Two points are easy to misread. First, for most submissions the small business fee is 25 percent of the standard fee, so the saving scales with the fee. Second, the annual establishment registration fee of USD 13,785 has no small business rate at all. FDA may grant a waiver of that annual fee (not the initial registration) only where paying it is a financial hardship, as FDA determines. Do not budget as if the establishment fee gets the small business discount, because it does not.

Why small business status does not roll over

Direct answer: a small business determination (SBD) is valid only for the fiscal year in which FDA grants it. Qualification is based on gross receipts or sales, including those of affiliates, of no more than USD 100 million. Because it is tied to the fiscal year, you must re-apply each year through the FDA Small Business Determination Program to keep the discount. There is no automatic renewal and no grace period.

This catches firms that qualified once and assumed the status was permanent. It is not. If your fiscal year 2026 SBD lapses on 30 September and you file a 510(k) on 2 October without a fresh fiscal year 2027 determination in hand, FDA bills the full USD 28,653, and it will not issue a receipt for the submission until the correct fee is paid. The fee gate stalls your review, not just your budget.

The CRA certification that Canadian firms miss

Direct answer: a US firm proves its size with a US federal income tax return. A Canadian firm cannot. Instead, a business headquartered outside the United States uses Form FDA 3602A and must obtain a National Taxing Authority Certification. In Canada, the national taxing authority is the CRA. This extra step, and the time it takes to get the CRA to certify your figures, is the part firms underestimate.

FDA sets specific requirements for the National Taxing Authority Certification. It must:

• Be in English
• Come from the national taxing authority of the country where the business is headquartered (the CRA for a Canadian firm)
• Report gross receipts or sales for the most recent year, in both the local currency and US dollars, stating the exchange rate used
• State the dates during which those receipts or sales were collected
• Bear the official seal of the national taxing authority

If your business has affiliates, each affiliate's receipts or sales count toward the USD 100 million threshold, and each foreign affiliate needs its own National Taxing Authority Certification. A single missing affiliate certification can sink the whole application.

Not sure whether your fiscal year 2026 small business status has lapsed, or how to line up the CRA certification in time? MFLRC manages FDA small business re-qualification and the wider submission timeline for Canadian device firms.

How to re-qualify: the practical steps

Direct answer: re-qualification is a short but time-sensitive sequence. The bottleneck is almost always the CRA certification, so start there.

1. Confirm your gross receipts or sales, including all affiliates, for the most recent year, and check they are at or below USD 100 million.
2. Complete the business and affiliate sections of the MDUFA Foreign Small Business Qualification form (Form FDA 3602A).
3. Submit the relevant section to the CRA and request a National Taxing Authority Certification that meets FDA's content and official-seal requirements.
4. File the completed Form FDA 3602A with the CRA certification (and each affiliate certification) to FDA and wait for your SBD decision and small business number.
5. Only submit fee-bearing applications once your fiscal year 2027 small business number is granted, and reference it when you pay.

Compliance checklist

• You know your current SBD expires 30 September 2026 and have diarised it
• Gross receipts or sales, including affiliates, are confirmed at or below USD 100 million
• You are using Form FDA 3602A (foreign firm), not Form FDA 3602 (US firm)
• The CRA certification is in English, in local currency and USD with the exchange rate, dated, and carries the official seal
• Every foreign affiliate has its own National Taxing Authority Certification
• You have allowed about 60 days for the FDA determination, plus CRA processing time, before any fee-bearing filing
• Your fee budget treats the annual establishment registration fee (USD 13,785) as a full fee with no small business rate
• You will not submit a fee-bearing application until the fiscal year 2027 small business number is granted

Common mistakes

• Assuming the status renews. An SBD is valid only for the fiscal year granted. Last year's number does not cover this year's submission.
• Filing a US tax return as proof. A Canadian firm needs a CRA National Taxing Authority Certification on Form FDA 3602A, not a tax return.
• Forgetting affiliates. Affiliate revenue counts toward the USD 100 million limit, and each foreign affiliate needs its own certification.
• Starting too late. The SBD decision alone takes roughly 60 days, and the CRA certification adds time. Begin before the submission is finished.
• Budgeting a discount on the establishment fee. There is no small business rate for annual establishment registration, only a discretionary hardship waiver.

Frequently asked questions

When does FDA medical device small business status expire?

At the end of each federal fiscal year, on 30 September. A Small Business Determination is valid only for the fiscal year in which FDA grants it, so the fiscal year 2026 status expires 30 September 2026 and you must re-qualify for fiscal year 2027.

How much does a 510(k) cost in FY2027, and what does the small business discount save?

The standard 510(k) fee is USD 28,653 and the small business fee is USD 7,163, a difference of USD 21,490 per submission. These rates apply from 1 October 2026 through 30 September 2027.

How does a Canadian firm qualify as an FDA small business?

By filing Form FDA 3602A with a National Taxing Authority Certification from the CRA, because a Canadian firm cannot use a US tax return. Gross receipts or sales, including affiliates, must be no more than USD 100 million. The CRA certification must meet FDA's content and official-seal requirements.

How long does an FDA Small Business Determination take?

FDA generally takes about 60 days to process a Small Business Determination request. That is on top of the time needed to obtain the CRA certification, so start well before your intended submission date.

Is the annual establishment registration fee discounted for small businesses?

No. The FY2027 annual establishment registration fee is USD 13,785 with no small business rate. FDA may grant a waiver of the annual fee (not the initial registration) only where paying it is a financial hardship, as FDA determines.

What happens if I file a 510(k) before my new small business status is granted?

FDA charges the full standard fee and will not begin its review until the correct fee is paid. You cannot apply the discount retroactively to a submission filed before your determination is in place, so time the filing after the number is granted.

How MFLRC can help

MFLRC supports Canadian medical device manufacturers filing with the FDA, from fee planning and small business re-qualification to the submission itself. We line up the CRA certification, complete Form FDA 3602A, and manage the timeline so the discount is in place before you file. We also help you use the recognized consensus standards route to streamline a 510(k), and align your quality system with FDA QMSR and ISO 13485 before your first US submission.

Our device work spans the full lifecycle: human factors submission planning, contract manufacturer and supplier oversight, and how to respond to an FDA Form 483 if an inspection turns up observations. A regulatory calendar that flags the 30 September deadline every year keeps this from becoming a fire drill.

Conclusion

The FDA small business discount is worth real money, USD 21,490 on a single 510(k), but it is not automatic and it is not permanent. It expires 30 September 2026, and for a Canadian firm the CRA National Taxing Authority Certification is the step that decides whether you keep it. Treat the deadline as a fixed point in your regulatory calendar, start the re-qualification before the submission is ready, and confirm your small business number is granted before you pay any fee. The firms that plan this out keep the discount. The ones that discover the expiry in October pay full price.

Sources and references

• FDA, Medical Device User Fee Rates for Fiscal Year 2027, Federal Register (FR doc 2026-15335, 91 FR 48134)
• FDA, Medical Device User Fee Amendments (MDUFA): Fees
• FDA, Reduced or Waived Medical Device User Fees: Small Business Determination (SBD) Program