Build a complete FDA device launch budget, not a registration-fee guess
A U.S. medical-device launch budget rarely consists of one FDA payment.
Teams may need to confirm classification, product codes, exemptions and a premarket pathway; prepare performance, electrical-safety, biocompatibility, software, cybersecurity or clinical evidence; build an eSTAR submission; close QMSR gaps; revise English labeling and UDI records; appoint a U.S. agent; register establishments; list devices; and prepare import and postmarket operations.
A vendor may bundle several of those tasks under a broad registration package, which makes it difficult to distinguish a fixed government fee from a private quote or an internal workload.
This calculator starts with the establishment scope and premarket pathway already confirmed by the user.
It applies the published FY 2026 or FY 2027 establishment, 510(k), De Novo, PMA and PMA periodic-reporting fees, while keeping testing, dossier, consulting, U.S.-agent and other market quotes editable.
It then connects the initial project to exchange-rate stress, annual renewal cost, unit contribution, launch-delay opportunity cost, first-year funding, three-year total cost, recovery units, payback, NPV and ROI.
The essential boundary: registration is not approval or certification
FDA explains that registration and listing in its database do not denote approval, clearance or authorization of an establishment or device.
FDA also does not issue medical-device establishment registration certificates or certify the registration information supplied by a firm.
Therefore, registration does not denote approval, and neither a registration number nor a private certificate should be marketed as “FDA approved” or “FDA certified.”
Confirm the product-specific basis separately, such as a 510(k) clearance, De Novo authorization, PMA approval or a valid exemption within its limitations.
Official FDA medical-device fees for FY 2026 and FY 2027
An FDA fiscal year runs from October 1 through September 30.
FY 2026 covers October 1, 2025 through September 30, 2026, while FY 2027 covers October 1, 2026 through September 30, 2027.
The filing, payment or registration date can therefore change the applicable fee even when both dates fall in calendar year 2026.
The figures below were verified against the official FDA MDUFA fee page on 14 August 2026.
FDA medical-device user fees for fiscal years 2026 and 2027| Fee item | FY 2026 standard | FY 2026 small | FY 2027 standard | FY 2027 small |
|---|
| Annual establishment registration · per establishment | $11,423 | No ordinary reduction | $13,785 | No ordinary reduction |
| 510(k) | $26,067 | $6,517 | $28,653 | $7,163 |
| De Novo | $173,782 | $43,446 | $191,020 | $47,755 |
| PMA · PDP · PMR · BLA | $579,272 | $144,818 | $636,732 | $159,183 |
| Class III periodic reporting · annual fee | $20,275 | $5,069 | $22,286 | $5,572 |
The establishment fee is charged per fee-paying establishment
One company can operate a headquarters, manufacturing site, contract manufacturer, contract sterilizer or specification-development site with different registration obligations.
Enter only the establishments confirmed as fee-paying under the FDA activity table; the calculator does not decide the obligation from a company name or address.
The FDA fee per device listing is $0
The published MDUFA schedule does not include a separate government fee for each listed device.
More products can still increase private and internal work for product-code mapping, submission links, UDI and GUDID data, labeling, translations and record maintenance.
Confirm the premarket pathway before choosing a fee
Device class alone is not enough to select a submission pathway.
Intended use, indications for use, product code, classification regulation, exemption limitations, technological characteristics and the availability of a legally marketed predicate can all change the route.
Broad statements such as “Class I is exempt, Class II uses 510(k), and Class III uses PMA” are useful orientation points but not product-specific conclusions.
Confirmed premarket-review exemption
Select this only after confirming the product code and every limitation on the exemption. A $0 submission fee does not remove general controls, registration, listing, QMSR, labeling, MDR or other applicable duties.
FDA 510(k)
Use the published 510(k) fee for a confirmed Traditional, Abbreviated or Special 510(k). Predicate selection and substantial-equivalence evidence require a separate regulatory assessment.
Accredited Third Party 510(k)
An eligible 510(k) reviewed and submitted by an FDA-recognized review organization has a $0 FDA user-fee line, but the organization can charge its own private review fee.
De Novo
This route may be available for a confirmed novel low- to moderate-risk device type without a legally marketed predicate. The calculator cannot determine risk, eligibility or authorization.
PMA
Premarket Approval generally applies to high-risk Class III devices. Clinical, manufacturing and facility evidence can dominate the project budget, and qualifying PMA supplements or periodic reports may add other fees.
513(g) or pre-submission work
A formal classification request or pre-submission interaction can have a separate scope and possibly a separate fee. Add its actual quote under strategy or other initial cost without duplicating work included elsewhere.
Small-business rates and waivers require FDA confirmation
- A business and its affiliates generally need gross receipts or sales of no more than $100 million and an FDA Small Business Determination for the selected fiscal year before reduced application fees can be used.
- A possible waiver for the first PMA, BLA, PDP or PMR has a separate $30 million threshold and requires an FDA-confirmed qualifying first application; it does not apply to 510(k) or De Novo submissions.
- Annual establishment registration does not receive the ordinary small-business percentage reduction.
- A firm with no more than $1 million, financial-hardship evidence and the applicable prior-year history may qualify for an FDA-approved annual registration renewal waiver; initial registration is excluded.
- A Korean small-business certificate or an estimated revenue figure is not a substitute for the selected-year FDA determination letter and number.
The FDA page current as of July 13, 2026 stated that the FY 2026 ordinary SBD window closed at 4:00 p.m. Eastern Time on August 1, 2026 and the FY 2027 window opened at 4:01 p.m. Eastern Time that day.
Submission windows, forms and processing time can change, so recheck the current SBD page before relying on a reduced fee.
U.S. agents, registration timing and foreign establishments
A foreign establishment must designate a U.S. agent
A foreign establishment that manufactures, prepares, propagates, compounds or processes a device imported into the United States must designate a U.S. agent in its registration information.
The agent must reside or maintain a place of business in the United States and be available during normal business hours.
FDA describes communication, import questions and inspection scheduling among the basic roles; MDR reporting or ownership of a 510(k) does not transfer automatically.
Annual review runs from October 1 through December 31
Establishments review registration information and device listings annually from October 1 through December 31 under 21 CFR Part 807.
A foreign establishment generally registers before export, but a device requiring premarket clearance or approval must obtain that decision before registration and listing.
Allow time for fee payment, PIN and PCN processing and completion in FURLS or DRLM rather than treating payment as the final registration step.
Prepare quote inputs without omissions or double counting
- Freeze the regulatory scope. Record the intended use, product-code candidate, confirmed class, exemption boundary, pathway, fee-paying establishment activities, foreign-establishment count and initial importer.
- Separate official fees from market quotes. Let the selected fiscal-year table supply FDA fees, while tests, clinical work, dossier preparation, consulting, translation and the U.S. agent remain vendor-entered values.
- Normalize currency and tax treatment. Identify whether each quote includes tax, bank charges and travel; convert non-USD quotes to USD with a documented planning rate before entry.
- Capture internal preparation. Add RA, QA, R&D, manufacturing, purchasing, management and legal hours needed to create records, answer questions and implement corrective work.
- Isolate annual obligations. Put establishment registration, the U.S. agent, PMA periodic reporting, registration support, QMSR upkeep and postmarket systems into the recurring section.
- Validate schedule and sales separately. A launch-delay input is a user project assumption, not an FDA processing promise; unit price, variable cost, returns and realized volume should come from distribution evidence or market research.
How the calculator turns inputs into decisions
Government fees, private quotes and internal work stay visible
The one-time FDA application fee is added to private initial quotes and a contingency applied only to those private quotes.
The resulting external cash is converted at the planning exchange rate, a confirmed non-repayable grant is capped at that cash amount, and internal preparation hours are added as an economic cost.
Annual official and private costs are shown separately, then included once in first-year funding and three times in the three-year nominal TCO.
Exchange-rate stress changes only USD-linked cash
The lower, base and higher scenarios retranslate first-year USD external cash at the selected stress band.
A KRW-denominated grant and internal labor cost do not move with the exchange rate, preventing domestic and foreign exposure from being blended.
The rate is a planning assumption, not a live, tax or customs valuation rate.
Payback subtracts recurring cost from contribution
Unit contribution equals net revenue minus variable cost, sales fees and return-related loss.
Monthly net benefit equals realized unit contribution minus one-twelfth of annual recurring cost, and the initial economic cost is divided by that benefit for post-launch payback.
If unit contribution or monthly net benefit is zero or negative, the calculator intentionally reports no payback instead of manufacturing a result.
Worked example: FY 2026 small-business 510(k) with two establishments
Consider a Korean manufacturer with two confirmed fee-paying foreign establishments and four device listings.
It holds an FY 2026 FDA small-business determination and uses a regular 510(k), a planning rate of ₩1,400 per USD, an 8-month launch delay and a 10% private-cost contingency.
The example enters $63,000 for one-time regulatory, submission, testing, translation, QMS, labeling, registration-support and import work; $21,500 for annual U.S.-agent, registration-support, QMS and postmarket work; 120 internal hours at ₩60,000; and a confirmed ₩8,000,000 non-repayable grant.
Worked example FDA launch-cost outputs in U.S. dollars and Korean won| Output | USD view | KRW view | Interpretation |
|---|
| Official annual establishment fee | $22,846 | ₩31,984,400 | Two establishments at $11,423 each |
| Small-business 510(k) fee | $6,517 | ₩9,123,800 | Requires the FY 2026 FDA determination |
| One-time external cash | $75,817 | ₩106,143,800 gross | $6,517 fee + $63,000 quote + $6,300 contingency |
| One-time economic cost | After KRW grant and labor | ₩105,343,800 | Gross cash − ₩8,000,000 grant + ₩7,200,000 internal work |
| Annual recurring cost | $44,346 | ₩62,084,400 | $22,846 official + $21,500 private recurring |
| First-year economic cost | $120,163 external | ₩167,428,200 | One-time cash + one annual cycle − grant + internal work |
| Three-year nominal TCO | At the planning rate | ₩291,597,000 | Initial economic cost + three annual cycles |
| One-time cost per device listing | Four-listing allocation | ₩26,335,950 | A project allocation, not an FDA listing fee |
Sales and recovery interpretation
Net unit revenue of $500, variable cost of $260 and combined sales-fee and return-loss rates of 15% produce $165, or ₩231,000, in unit contribution.
At 100 planned units per month and 70% realization, monthly sales contribution is ₩16,170,000; after ₩5,173,700 in monthly recurring cost, monthly net benefit is ₩10,996,300.
The initial cost requires 457 units and about 9.58 months after launch; adding the 8-month preparation delay produces about 17.58 calendar months.
The 18-month target requires 48 realized units per month, while the 8-month delay represents ₩129,360,000 of contribution opportunity cost.
Use the result in practical planning scenarios
Payment crosses October 1
Switch from FY 2026 to FY 2027 instead of carrying an expired quote forward. Both the per-establishment fee and submission fee can change, so confirm the contractual payment date.
Several products share establishments
More device listings do not add a per-listing FDA fee, but each product can require different testing, labeling, UDI records and a separate submission pathway. Split shared and incremental quotes.
The U.S.-agent quote is $0
A firm may have a valid no-charge arrangement, but document agent eligibility, designation, written acceptance, availability and contractual responsibilities rather than assuming that a blank quote means no obligation.
The FDA small-business decision is pending
Reserve the standard fee and do not recognize the reduction as a confirmed saving until the selected-year determination is issued. Include application-window and processing slack.
Testing or clinical scope is unresolved
Treat $0 as unknown scope, not an exemption. Confirm protocols, sample quantities, laboratories, retesting and deficiency-response assumptions before reducing contingency.
Exchange-rate risk is material
Allocate the difference between base and higher first-year cost to the dollar payment calendar. Add any forward, hedge or bank cost separately rather than embedding it in the FDA fee.
Budgeting tips and cautions
- Require every proposal to identify the product, intended use, models or variants, product-code candidate, pathway, included tests, sample quantity, deficiency support, retesting, tax and validity period.
- Break a registration package into U.S.-agent, UDI, initial-importer, 510(k), establishment-registration and annual-renewal lines so that overlapping vendors are not paid twice.
- Paying an FDA user fee does not guarantee a favorable decision, and FDA may not begin review until the full applicable fee is processed.
- A Small Business Determination expires with its fiscal year, so confirm the next-year status before a delayed submission.
- Establishment registration is renewed by fiscal year; it should not be treated as a one-time launch-only payment.
- QMSR became effective on February 2, 2026, but an ISO 13485 certificate alone does not automatically demonstrate every FDA requirement.
- Launch-delay loss is a contribution-opportunity scenario, not an invoice or immediate cash requirement; keep it separate from first-year external cash.
- Validate commercial demand and distribution commitments independently from the probability or timing of FDA clearance, authorization or approval.
Frequently asked questions
Does listing more devices increase the FDA government fee?
The current MDUFA schedule has no separate fee for each device listing. More products can still increase testing, documentation, UDI, labeling and submission work.
Does a Korean small-business certificate automatically qualify for the reduced FDA rate?
No. The business and affiliates must meet the FDA revenue rule and obtain a Small Business Determination for the selected fiscal year.
Is the establishment fee reduced to one quarter for a small business?
No. The ordinary small-business reduction does not apply to establishment registration. Only an FDA-confirmed qualifying renewal waiver is subtracted, and initial registration is excluded.
Is an Accredited Third Party 510(k) completely free?
No. The FDA user-fee line can be $0 for an eligible submission reviewed by a recognized organization, while the review organization can charge a private fee.
Does a U.S. agent automatically own the 510(k) or file MDR reports?
No. FDA describes the basic agent role around communication, import questions and inspection scheduling. Submission ownership and reporting responsibilities depend on separate legal and contractual assignments.
Should I select FY 2026 or FY 2027?
Use the FDA fiscal year that contains the actual payment, filing or registration date. From October 1, 2026, use FY 2027 and compare both schedules when delay is possible.
Can the product be sold immediately once the calculator shows a result?
No. This is a budget simulation. The product must still satisfy its actual premarket decision, registration, listing, QMSR, labeling, UDI, import and postmarket obligations.
Separate published fees from actual launch quotes now
Confirm the product pathway and establishment scope, enter written quotes, and compare initial investment, first-year funding, annual renewal, exchange-rate stress and recovery on one basis.
Use the result to frame a budget review, then revalidate every official fee and filing requirement with current FDA material and qualified advisers before payment or submission.