--- title: "FDA Device User Fees FY2026: 510(k), De Novo & PMA Costs" description: "Every FY2026 MDUFA fee in one table, with small-business rates, the submissions that cost nothing, and a calculator that totals your first year with FDA." lang: en json-ld: | { "@context": "https://schema.org", "@type": "FAQPage", "mainEntity": [ { "@type": "Question", "name": "How much does a 510(k) cost in FY2026?", "acceptedAnswer": { "@type": "Answer", "text": "The FY2026 FDA user fee for a 510(k) premarket notification is $26,067 at the standard rate and $6,517 for a business certified small by CDRH." } }, { "@type": "Question", "name": "Does a Pre-Submission cost anything?", "acceptedAnswer": { "@type": "Answer", "text": "No. Q-Submissions, including Pre-Subs and Breakthrough Device designation requests, carry no MDUFA user fee." } }, { "@type": "Question", "name": "Who qualifies for FDA small business fees?", "acceptedAnswer": { "@type": "Answer", "text": "A business with gross receipts or sales of $100 million or less, certified through CDRH's Small Business Determination program, pays reduced fees. At $30 million or less, the first PMA fee can be waived outright." } }, { "@type": "Question", "name": "What number does FDA actually look at?", "acceptedAnswer": { "@type": "Answer", "text": "Total gross receipts or sales reported on your most recent federal income tax return, added to the gross receipts or sales of every affiliate, worldwide. Not profit, not headcount, not money raised. If the combined figure is $100 million or less you qualify for reduced fees. At $30 million or less you can also claim a one-time waiver of your first PMA, PDP, PMR or BLA fee." } }, { "@type": "Question", "name": "Who counts as an affiliate?", "acceptedAnswer": { "@type": "Answer", "text": "Any business entity that controls you, that you control, or that is under common control with you by a third party. Control can come from majority ownership, board control, or contractual power to direct management. It runs in every direction: parents, subsidiaries, sister companies under the same parent, and foreign entities all get added in." } }, { "@type": "Question", "name": "Does a VC investor make my portfolio-company siblings affiliates?", "acceptedAnswer": { "@type": "Answer", "text": "Only if the investor actually controls both companies. A minority preferred stake with standard protective provisions is normally not control, so the other portfolio companies are not affiliates. A majority stake, or board and voting rights that let the fund direct management, can make them affiliates and pull their revenue into your total. FDA decides this on the facts you disclose, so describe the ownership structure accurately in the request." } }, { "@type": "Question", "name": "Example: pre-revenue startup owned by a large parent", "acceptedAnswer": { "@type": "Answer", "text": "A device startup books $0 in revenue but a strategic manufacturer owns 60% of it. The parent reports $2.4 billion in sales. Combined gross receipts are $2.4 billion, so the startup does not qualify and pays the full $26,067 for a 510(k). Zero revenue of your own does not help when a controlling parent is over the line." } }, { "@type": "Question", "name": "Example: founder with two companies under common control", "acceptedAnswer": { "@type": "Answer", "text": "A founder owns 100% of a $12 million contract manufacturing business and 100% of a new diagnostics company with $400,000 in sales. Both are under common control, so FDA adds them: $12.4 million combined. That is under $100 million, so the diagnostics company gets reduced fees, and because it is also under $30 million it can claim the one-time first-PMA waiver. Both tax returns must go into the request." } }, { "@type": "Question", "name": "Example: foreign firm with no US tax return", "acceptedAnswer": { "@type": "Answer", "text": "A German manufacturer with EUR 8 million in sales and a small US sales subsidiary files a Small Business Request. The German entity submits a certified Section III of Form FDA 3602N signed by its national taxing authority, and the US subsidiary submits its signed federal income tax return. Missing either document gets the request denied and you pay standard fees for that fiscal year." } }, { "@type": "Question", "name": "What happens if one affiliate does not qualify?", "acceptedAnswer": { "@type": "Answer", "text": "The whole request fails. Eligibility is judged on the combined total, so a single affiliate over the threshold disqualifies everyone in the group. There is no partial or prorated small business status." } }, { "@type": "Question", "name": "When do I need the determination in hand?", "acceptedAnswer": { "@type": "Answer", "text": "Before you submit. Certification is granted per fiscal year and does not backdate, so a submission that arrives before FDA grants your Small Business Determination is invoiced at the standard rate. Requests for a fiscal year can be filed from August 1 of the prior year through August 1 of that year, and you refile every year." } } ] } --- [Skip to content](#main) [ MedTech Launch Guide Education Hub for Founders ](/) [Roadmap](/roadmap) [Topics](/topics) Tools [Pulse](/pulse)Search ⌘K[Start Here](/start) Search ⌘K 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](https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa-fees) [Federal Register 2025-14412](https://www.federalregister.gov/documents/2025/07/30/2025-14412/medical-device-user-fee-rates-for-fiscal-year-2026) 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 Standard rate Over $100M or not certified Small business $100M or less, SBD granted Small business, first PMA $30M or less, waiver unused 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 + Annual establishment registration $11,423 · owed by nearly everyone, no small-business rate 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](https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa-fees) 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 Takeaway The 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 Takeaway The 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 Takeaway The 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 Takeaway Fees 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](https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa-fees) 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](https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa-fees) 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](https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa-fees) 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](https://www.federalregister.gov/documents/2025/07/30/2025-14412/medical-device-user-fee-rates-for-fiscal-year-2026) 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](https://www.federalregister.gov/documents/2025/07/30/2025-14412/medical-device-user-fee-rates-for-fiscal-year-2026) 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](https://www.federalregister.gov/documents/2025/07/30/2025-14412/medical-device-user-fee-rates-for-fiscal-year-2026) Standard: $40,549 Small business: $10,137 BLA efficacy supplement Priced identically to an original BLA. [Verify: Federal Register 2025-14412](https://www.federalregister.gov/documents/2025/07/30/2025-14412/medical-device-user-fee-rates-for-fiscal-year-2026) Standard: $579,272 Small business: $144,818 30-day notice Manufacturing-process changes to an approved PMA device. [Verify: Federal Register 2025-14412](https://www.federalregister.gov/documents/2025/07/30/2025-14412/medical-device-user-fee-rates-for-fiscal-year-2026) 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](https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa-fees) 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](https://www.federalregister.gov/documents/2025/07/30/2025-14412/medical-device-user-fee-rates-for-fiscal-year-2026) 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](https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing) $11,423 No reduced rate Rates published by FDA in [Federal Register notice 2025-14412](https://www.federalregister.gov/documents/2025/07/30/2025-14412/medical-device-user-fee-rates-for-fiscal-year-2026), July 30, 2025. FDA resets these every summer. Primary sources - [FDA MDUFA fee schedule](https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa-fees) The authoritative table of FY2026 standard and small business rates for every device submission type. - [Federal Register notice 2025-14412](https://www.federalregister.gov/documents/2025/07/30/2025-14412/medical-device-user-fee-rates-for-fiscal-year-2026) Published July 30, 2025. The legal instrument that sets the FY2026 rates effective October 1, 2025. - [Annual establishment registration fee](https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing) FDA's device registration and listing page, where the annual establishment fee and payment mechanics are stated. - [Small Business Determination (SBD) Program](https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/reduced-or-waived-medical-device-user-fees-small-business-determination-sbd-program) Eligibility thresholds, affiliate rules, required tax documentation and the filing window. - [User Fee Cover Sheet (Form FDA 3601)](https://userfees.fda.gov/OA_HTML/mdufaCAcdLogin.jsp) Where you generate the payment identification number that must accompany a premarket submission. - [Third party review program](https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/510k-third-party-review-program) Confirms that 510(k)s cleared through an accredited third party carry no FDA user fee. 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](https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/reduced-or-waived-medical-device-user-fees-small-business-determination-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. ### What number does FDA actually look at? ### Who counts as an affiliate? ### Does a VC investor make my portfolio-company siblings affiliates? ### Example: pre-revenue startup owned by a large parent ### Example: founder with two companies under common control ### Example: foreign firm with no US tax return ### What happens if one affiliate does not qualify? ### When do I need the determination in hand? 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](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-medical-device-submissions-q-submission-program) 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](https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program) IDE application Investigational Device Exemption submissions carry no MDUFA fee. [FDA](https://www.fda.gov/medical-devices/how-study-and-market-your-device/investigational-device-exemption-ide) 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](https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/510k-third-party-review-program) 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](/roadmap) to scope the rest, and see [the regulatory stage](/roadmap/regulatory-pathway) for how pathway choice drives everything downstream. MedTech Launch Guide The independent education hub for medtech innovators bringing devices to the US market - paired with a live pulse of what FDA, CMS, CISA and investors are doing right now. 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