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    Regulatory · Cost

    What FDA will actually charge you in FY2026.

    Every medical device user fee for the fiscal year running October 1, 2025 through September 30, 2026, plus the submissions that cost nothing and the two thresholds that cut your bill by 75 percent or more.

    Source: FDA MDUFA fee schedule Federal Register 2025-14412 Verified 2026-07-27

    Heads up on the rollover: FDA publishes the next fiscal year's rates in the Federal Register around the start of August, and they take effect 1 October 2026. As of 2026-07-27 the FY2027 notice has not been published, so every figure below is the current FY2026 rate.

    Year-one estimator

    Add the submissions you expect to file.

    This totals FDA user fees only. It does not include consultants, testing labs, notified bodies, clinical costs or your own team's time, which together usually dwarf the fee itself.

    Small business status
    510(k) premarket notification
    $26,067 each
    1
    De Novo classification request
    $173,782 each
    0
    PMA, PDP, PMR or BLA
    $579,272 each
    0
    Panel-track supplement
    $463,418 each
    0
    180-day supplement
    $86,891 each
    0
    Real-time supplement
    $40,549 each
    0
    BLA efficacy supplement
    $579,272 each
    0
    30-day notice
    $9,268 each
    0
    513(g) request for classification information
    $7,820 each
    0
    Class III annual periodic report
    $20,275 each
    0
    Estimated FY2026 FDA fees
    $37,490
    Standard rates
    510(k) premarket notification × 1$26,067
    Establishment registration$11,423
    Assumptions used
    • Rates are the FY2026 schedule in effect October 1, 2025 through September 30, 2026. A submission received on or after October 1, 2026 is billed at FY2027 rates.
    • Standard rates applied. No CDRH small business determination assumed.
    • The 510(k) is assumed to be reviewed by FDA directly. A 510(k) routed through an accredited third-party reviewer carries no FDA user fee, though the reviewer charges its own.
    • One annual establishment registration fee of $11,423 is included. There is no reduced small business rate. Each additional registered establishment owes its own fee.
    • FDA user fees only. Q-Submissions, Breakthrough designation requests and IDEs are free and excluded, as are testing, consultants, clinical costs and staff time.

    Estimate only. Confirm the current rate on the FDA fee page before you wire anything, and generate a Device Facility User Fee cover sheet in FDA's DFUF system to get the payment identification number.

    Worked examples

    Four companies, four very different bills.

    Same FY2026 rate card, run against realistic situations. Every figure below is pulled from the table on this page, so the arithmetic matches the calculator exactly.

    Pre-revenue software startup filing one 510(k)

    Seed-stage SaMD company, $0 revenue, $4M raised, no parent or controlling investor. A predicate exists, so the pathway is a Traditional 510(k), and the company registers one US establishment.

    Small business rates

    Money raised is not revenue, and there are no affiliates to aggregate, so combined gross receipts are $0. CDRH grants small business status, filed and granted before the 510(k) goes in.

    510(k) premarket notification$6,517

    Traditional 510(k), reviewed by FDA rather than a third party.

    Annual establishment registration$11,423

    One establishment registration, owed every fiscal year with no small business discount.

    Total FDA user fees, FY2026$17,940

    TakeawayThe free SBD filing saved this company $19,550 on the 510(k) alone. Note that the establishment fee is now the larger of the two line items.

    Class III implant startup filing its first PMA

    Clinical-stage implant company with $12M in gross receipts from a legacy service line, no affiliates over the threshold, filing an original PMA for its first approved product.

    Small business plus first-PMA waiver

    Combined gross receipts of $12M sit under the $30M line, and the company has never used its one-time waiver, so the first PMA fee is waived entirely rather than merely reduced.

    PMA, PDP, PMR or BLA$0

    Waived. First PMA, PDP, PMR or BLA. Waived once per business, ever.

    Annual establishment registration$11,423

    Still owed. The PMA waiver does not touch establishment registration.

    Total FDA user fees, FY2026$11,423

    TakeawayThe waiver is worth $579,272 against the standard rate. Burn it on your largest application, not on a small one, because you only get it once.

    Novel diagnostic owned by a large corporate parent

    Diagnostics subsidiary with $2M in sales, 70% owned by a strategic manufacturer reporting $2.4B. No valid predicate exists, so the pathway is De Novo, and the group registers two US establishments.

    Standard rates

    The controlling parent is an affiliate, so FDA adds its revenue. Combined gross receipts of roughly $2.4B are far over $100M and the subsidiary pays standard rates despite its own small revenue.

    De Novo classification request$173,782

    De Novo classification request at the standard rate.

    Annual establishment registration × 2$22,846

    $11,423 each. Two registered establishments, each owing the full annual fee.

    Total FDA user fees, FY2026$196,628

    TakeawayThe affiliate rule, not your own P&L, decides your rate. Model fees off the consolidated group before you promise a board a number.

    Approved PMA device, one year of post-market changes

    Commercial company certified small, running a design change that needs a 180-day supplement, a manufacturing-site change handled by 30-day notice, and its recurring annual report.

    Small business rates

    Combined gross receipts stay under $100M and SBD was refiled for the new fiscal year. Certification lapses each year, so this company files the free request again every August.

    180-day supplement$21,723

    Significant design change to an approved PMA device.

    30-day notice$4,634

    Manufacturing-process change, the cheapest way to move a change through.

    Class III annual periodic report$5,069

    Class III annual periodic report, due every year for as long as the PMA lives.

    Annual establishment registration$11,423

    Annual establishment registration.

    Total FDA user fees, FY2026$42,849

    TakeawayFees do not stop at approval. Budget a recurring post-market line, and check whether a change can be handled by 30-day notice before defaulting to a supplement.

    Rates are the published FY2026 schedule. Totals cover FDA user fees only, not testing, consultants, clinical work or staff time.

    The full schedule

    Every FY2026 rate, and when it applies.

    Submission
    Standard
    Small business
    510(k) premarket notification

    Applies to Traditional, Abbreviated and Special 510(k)s. No fee if the submission goes through an FDA-accredited third-party reviewer.

    Verify: FDA fee schedule
    Standard: $26,067
    Small business: $6,517
    De Novo classification request

    The route for a low-to-moderate risk device with no valid predicate. Grants you a classification others can later use as a predicate.

    Verify: FDA fee schedule
    Standard: $173,782
    Small business: $43,446
    PMA, PDP, PMR or BLA

    Class III original applications. A small business with gross receipts of $30M or less can have its first PMA/PDP/PMR/BLA fee waived entirely.

    Verify: FDA fee schedule
    Standard: $579,272
    Small business: $144,818
    Panel-track supplement

    A PMA supplement with new clinical data supporting a significant change in design or indication.

    Verify: Federal Register 2025-14412
    Standard: $463,418
    Small business: $115,855
    180-day supplement

    A significant change in design, components or specifications of an approved PMA device.

    Verify: Federal Register 2025-14412
    Standard: $86,891
    Small business: $21,723
    Real-time supplement

    A minor PMA change reviewed in a live meeting or teleconference with the review team.

    Verify: Federal Register 2025-14412
    Standard: $40,549
    Small business: $10,137
    BLA efficacy supplement

    Priced identically to an original BLA.

    Verify: Federal Register 2025-14412
    Standard: $579,272
    Small business: $144,818
    30-day notice

    Manufacturing-process changes to an approved PMA device.

    Verify: Federal Register 2025-14412
    Standard: $9,268
    Small business: $4,634
    513(g) request for classification information

    Ask FDA in writing how it classifies your device. Useful when the pathway is genuinely ambiguous, but it is not a substitute for a Pre-Sub.

    Verify: FDA fee schedule
    Standard: $7,820
    Small business: $3,910
    Class III annual periodic report

    Recurring annual fee on PMAs, PDPs and PMRs.

    Verify: Federal Register 2025-14412
    Standard: $20,275
    Small business: $5,069
    Annual establishment registration

    Owed by every registered establishment, every fiscal year, whether or not you file anything. There is no reduced small-business rate, only a narrow hardship waiver.

    Verify: FDA registration and listing
    $11,423
    No reduced rate

    Rates published by FDA in Federal Register notice 2025-14412, July 30, 2025. FDA resets these every summer.

    Primary sources

    Every figure on this page was checked against these pages on 2026-07-27.

    Small business determination

    The cheapest paperwork you will ever file.

    An SBD request costs nothing and cuts a 510(k) fee from $26,067 to $6,517. Certification is per fiscal year, so you refile every year, and it must be granted before you submit. File it early: if your submission arrives before the determination, you pay full price.

    FDA SBD program
    $100 million or less in gross receipts or sales

    Reduced fee on 510(k), De Novo, PMA, BLA, PDP, PMR, PMA supplements, PMA annual reports and 513(g) requests.

    $30 million or less in gross receipts or sales

    First PMA, PDP, PMR or BLA fee waived entirely. One waiver per business, ever.

    $1 million or less, plus documented financial hardship

    Possible waiver of the annual establishment registration fee, excluding your initial registration. Requires proof of a prior year's payment.

    What actually counts as a small business.

    FDA's test is revenue-based, and it is measured across your affiliates, not just the entity filing the submission.

    Gross receipts or sales, not headcount or funding

    FDA looks at total gross receipts or sales for the most recent tax year. Employee count, venture funding raised and valuation are irrelevant. Money you raised is not revenue, so most pre-revenue startups qualify.

    Affiliates count against you

    The threshold applies to the business plus all affiliates combined. An affiliate is any entity that controls, is controlled by, or is under common control with you. A corporate parent or a majority investor with control can push you over $100 million even if your own revenue is zero.

    Proven with tax returns

    US firms upload signed federal income tax returns for the most recent tax year for the business and every affiliate. Foreign firms and foreign affiliates submit a certified Section III of Form FDA 3602N signed by their national taxing authority.

    Free, but time-boxed

    There is no fee for a Small Business Request. It is filed electronically through the CDRH Portal, applies to one fiscal year only, and the filing window for a given fiscal year runs August 1 of the prior year through August 1 of that year.

    Source: FDA SBD Program page and the Small Business Qualification and Determination guidance.

    Eligibility FAQ

    Affiliates, parents and the questions that decide your fee.

    Most denied Small Business Requests fail on the affiliate rule, not on the applicant's own revenue. Here is how the aggregation works, with worked examples.

    Source: FDA Small Business Determination Program and the Medical Device User Fee Small Business Qualification and Determination guidance. Verified 2026-07-27.

    Costs nothing

    Five things founders budget for that FDA does not charge for.

    Q-Submission / Pre-Submission

    Written feedback or a meeting with the review division before you submit. No user fee, and it is the single highest-leverage free thing FDA offers.

    FDA
    Breakthrough Device designation request

    Submitted as a Q-Sub. No fee. Designation does not reduce your later 510(k), De Novo or PMA fee.

    FDA
    IDE application

    Investigational Device Exemption submissions carry no MDUFA fee.

    FDA
    Class I and most Class II exempt devices

    If your product code is 510(k)-exempt you owe no premarket fee. You still owe the annual establishment registration fee.

    510(k) via an accredited third-party reviewer

    No FDA user fee, though the third-party review organization charges its own fee.

    FDA

    User fees are a rounding error next to the real cost of a submission. Testing, biocompatibility, software documentation, cybersecurity evidence under FD&C Act Section 524B, quality system build-out and clinical data typically run one to two orders of magnitude higher. Use the launch roadmap to scope the rest, and see the regulatory stage for how pathway choice drives everything downstream.