Pre-production brief
| Field | Definition |
|---|---|
| Role | Founder, finance owner, or first RA/QA hire planning a U.S. 510(k) budget. |
| Scenario | The team expects a 510(k) in the current fiscal year and wants to avoid budgeting the standard user fee if the business may qualify for the reduced fee. |
| Concrete problem | They do not know whether the company may qualify for the reduced fee, when FDA needs the small-business request, or what happens if they submit before the decision number is issued. |
| Available inputs | Expected submission month, current fiscal year, affiliate structure, most recent tax-year revenue evidence, organization identifiers, and the planned 510(k) owner. |
| Useful output | A dated fee-planning note showing the standard and reduced fee amounts, SBD timing, document checklist, and escalation questions for finance and RA/QA review. |
| TrueMedDevice role | Organize FDA public-source fee rules, timing notes, and packet prompts without determining fee eligibility or submission strategy. |
What the official fee question actually is
This is not the same question as total 510(k) budget. The narrow question here is whether the submission should be planned around the standard FDA user fee or the reduced small-business fee for the current fiscal year.
As of fiscal year 2026, FDA's MDUFA fee page lists the 510(k) standard fee at $26,067 and the small-business fee at $6,517. FDA also says all Traditional, Special, and Abbreviated 510(k)s use the same 510(k) user fee.
That means the first useful decision is not 'Which 510(k) type is cheaper?' The user-fee question is whether the business has the FDA small-business determination in place before the fee becomes due.
Practical workflow before you pay
| Step | What to check | Why it matters |
|---|---|---|
| 1. Pin the fiscal year | Match your likely submission date to FDA's current fiscal-year fee table. | The exact fee amount depends on the date FDA receives the submission. |
| 2. Add up affiliates | Use the business plus all affiliates when reviewing the $100 million small-business threshold. | FDA's small-business threshold is not just the parent company's standalone revenue. |
| 3. Start the SBD request early | Use the FDA small-business workflow before the submission fee is due and plan around the 60-day support window in the guidance. | Late paperwork can force the team onto the standard fee timeline. |
| 4. Wait for the decision number if you need the reduced fee | Do not assume the reduced fee applies until FDA issues the Small Business Decision number. | FDA says it will not accept the reduced fee without that number and will not refund the difference later. |
| 5. Prepare payment and cover sheet together | Line up the payment method, FDA Form 3601, and internal approval owner. | A ready eSTAR file can still stall if the payment packet is incomplete. |
The traps this page helps you avoid
- Treating the reduced fee as automatic because the business 'should qualify.'
- Using only the parent-company revenue and forgetting affiliate totals.
- Assuming a later refund will fix an early full-fee payment.
- Waiting until the eSTAR file is almost finished before starting the small-business request.
- Confusing fee planning with the separate questions of 510(k) need, type, exemption, or third-party review fit.
Workload and cost framing
The direct fee delta is large enough to matter in an early budget. For fiscal year 2026, the gap between the standard and reduced 510(k) fee is $19,550.
The work itself is usually light compared with a full submission, but it is deadline-sensitive. Expect finance or founder time to gather affiliate and tax-year evidence, plus RA/QA or operations time to align the submission month, the SBD request, the Form 3601 packet, and the eSTAR handoff.
If the small-business decision is still open when the submission is ready, the real business question becomes whether to wait for the reduced-fee path or move ahead on the standard fee. This article helps structure that question; it does not decide it.
What TrueMedDevice can prepare
TrueMedDevice can turn the public FDA fee rules into a dated fee-planning brief: current fee table, threshold notes, affiliate-data prompts, payment-packet checklist, and the questions your finance owner or consultant should answer before the submission month is committed.
Source ledger
What it can tell you
The current fiscal-year application fees, including the standard and small-business 510(k) fees and the note that FDA-accredited third-party review 510(k)s do not carry an FDA user fee.
What it cannot decide
Whether your business qualifies for the reduced fee, whether third-party review is appropriate, or whether your device should use a 510(k) at all.
What it can tell you
When payment is required, how the Medical Device User Fee Cover Sheet works, and that a Small Business Decision number must be on the cover sheet to use the reduced fee.
What it cannot decide
Your final fee status, your submission strategy, or whether a delayed submission is the right business choice.
What it can tell you
Which submission types may receive reduced fees, the gross-receipts thresholds FDA uses for reduced-fee and waiver decisions, and the current electronic SBD workflow including Form 3602N for fiscal year 2026 and later.
What it cannot decide
Whether your documentation is sufficient or whether FDA will grant your specific request.
What it can tell you
That supporting information for reduced-fee requests must be submitted at least 60 days before the fee is due and that applicants should not submit an application until the Small Business Decision number is obtained if they want the reduced fee.
What it cannot decide
Whether your affiliate structure, revenue evidence, or chosen submission date will satisfy FDA in your specific case.
What it can tell you
That Traditional, Special, and Abbreviated 510(k)s require the same user fee and that 510(k) submissions generally must be sent as electronic submissions using eSTAR unless exempted.
What it cannot decide
Which 510(k) type fits your device or whether your submission is exempt from electronic-submission requirements.
What it can tell you
That foreign manufacturers may submit a 510(k) directly and that a new company should not register its facility before it is within 30 days of manufacturing and distributing the device.
What it cannot decide
Who in your launch chain should hold the submission, your importer structure, or your establishment-registration obligations.
Frequently asked questions
Can a 510(k) get the same first-application fee waiver as a PMA?
No. FDA's user-fee pages say 510(k)s may receive the reduced small-business fee, but the first premarket application or report fee waiver applies to PMA, Product Development Protocol, Premarket Report, or certain Biologics License Application submissions, not to 510(k)s.
If we think we qualify, can we submit first and fix the fee later?
That is the main risk this page is trying to prevent. FDA says the Small Business Decision number must be on the Medical Device User Fee Cover Sheet to use the reduced fee, and FDA will not refund the difference between the standard and small-business fee after the submission has been received.
Does the reduced fee change based on whether we file a Traditional, Special, or Abbreviated 510(k)?
No. FDA says Traditional, Special, and Abbreviated 510(k)s use the same 510(k) user fee. The fee question is the business-status determination, not the 510(k) label by itself.
Can a foreign manufacturer still use the small-business path?
Possibly, but the page does not make that determination. FDA's 510(k) Frequently Asked Questions say a foreign manufacturer may submit a 510(k) directly, and the SBD page explains how businesses without a national taxing authority can submit alternative evidence. You still need FDA's determination for your specific request.
Need the fee packet and submission packet to line up?
Request a review-ready starter pack so your team can see the fee table, affiliate-data prompts, and 510(k) handoff questions in one place before budget approval.