FDA Medical Device User Fees FY 2027: MDUFA Rate Table and Budget Decisions
Complete guide to FDA medical device user fee rates for FY 2027 (MDUFA V), covering 510(k), De Novo, PMA, registration fees, small business waivers, and filing decisions.
On July 30, 2026, the U.S. Food and Drug Administration (FDA) published its official Federal Register notice (91 FR 48134, Docket No. FDA-2026-N-7492) setting the Medical Device User Fee Amendments (MDUFA V) rate schedule for Fiscal Year 2027 (October 1, 2026 through September 30, 2027). As the final year of the five-year MDUFA V reauthorization period (FY 2023–FY 2027), FY 2027 introduces significant fee increases across premarket applications, De Novo requests, periodic reporting, and annual establishment registrations.
For regulatory affairs directors, chief financial officers, and medtech startup founders preparing budgets for the upcoming fiscal year, understanding these rate changes is vital. A missed deadline or delayed submission can mean thousands of dollars in unexpected user fee surcharges or administrative holds.
Direct Answer: Key FY 2027 MDUFA User Fee Rates
For FY 2027 (effective October 1, 2026 through September 30, 2027), the standard 510(k) premarket notification fee is $28,653 (small business rate: $7,163). A De Novo classification request is $191,020 (small business: $47,755), and a PMA, PDP, PMR, or BLA application is $636,732 (small business: $159,183). The annual establishment registration fee is $13,785, and it is charged at the same rate to every establishment — there is no 25% small business rate for it. The only relief available is a discretionary financial-hardship waiver that FDA may, but is not required to, grant to businesses with gross receipts of $1 million or less (and it does not cover an initial registration).
Compared to FY 2026, premarket submission fees rose 9.9%, while the annual establishment registration fee rose 20.7% (from $11,423 to $13,785). That divergence is structural, not discretionary: by statute, the entire $63,542,885 performance improvement adjustment is loaded onto establishment registration fees alone, and establishment fees are also the residual lever FDA uses to close any remaining gap to the inflation-adjusted revenue target.
One date matters more than the rate table itself. Small Business Determination (SBD) status is granted for a single fiscal year and expires at the end of it. Per FDA's SBD program page, the FY 2026 Small Business Request window closed on August 1, 2026 at 4:00 PM ET, and the FY 2027 window opened the same day at 4:01 PM ET. If you plan to file anything at a small business rate on or after October 1, 2026, your FY 2027 request should already be in the CDRH Portal.
What Are the FY 2027 FDA Medical Device User Fees?
Under MDUFA V, user fees are divided into two distinct categories: submission fees (paid when filing specific premarket or classification documents) and establishment fees (paid annually by registered medical device manufacturing and processing facilities).
The table below outlines the complete official rate schedule for FY 2027 alongside the previous FY 2026 rates for comparison:
| Application / Fee Type | Statutory % of Full Fee | FY 2026 Standard | FY 2027 Standard | FY 2026 Small Business | FY 2027 Small Business | YoY Change |
|---|---|---|---|---|---|---|
| PMA, PDP, PMR, BLA | Base fee in statute | $579,272 | $636,732 | $144,818 | $159,183 | +9.9% |
| Premarket Report (515(c)(2)) | 100% | $579,272 | $636,732 | $144,818 | $159,183 | +9.9% |
| BLA Efficacy Supplement | 100% | $579,272 | $636,732 | $144,818 | $159,183 | +9.9% |
| Panel-Track Supplement | 80% | $463,418 | $509,386 | $115,855 | $127,347 | +9.9% |
| De Novo Classification Request | 30% | $173,782 | $191,020 | $43,446 | $47,755 | +9.9% |
| 180-Day PMA Supplement | 15% | $86,891 | $95,510 | $21,723 | $23,878 | +9.9% |
| Real-Time PMA Supplement | 7% | $40,549 | $44,571 | $10,137 | $11,143 | +9.9% |
| 510(k) Premarket Notification | 4.5% | $26,067 | $28,653 | $6,517 | $7,163 | +9.9% |
| 30-Day Notice | 1.60% | $9,268 | $10,188 | $4,634 | $5,094 | +9.9% |
| 513(g) Request for Classification Information | 1.35% | $7,820 | $8,596 | $3,910 | $4,298 | +9.9% |
| Annual Fee for Periodic Reporting (Class III) | 3.50% | $20,275 | $22,286 | $5,069 | $5,572 | +9.9% |
| Annual Establishment Registration | Base fee in statute | $11,423 | $13,785 | $11,423 | $13,785 | +20.7% |
Source: Official FDA Federal Register Notice 91 FR 48134 (July 30, 2026), Table 5. FY 2026 column from the FY 2026 medical device user fee rate notice (published July 30, 2025) as republished on FDA's MDUFA fees page. All figures are official statutory fees, not estimates.
Two Fee Types That Are Routinely Mis-Budgeted
Two rows on that table cause more budget errors than the rest combined:
- The Class III periodic reporting fee is 3.5% of the full fee, not a fraction of the supplement fee. At $22,286 for FY 2027, it is an annual charge per approved PMA/PDP/PMR that continues for the commercial life of the device. A company with six approved PMAs carries $133,716 per year in periodic reporting fees alone before it files anything new.
- There is no separate "135-day supplement" fee line. A 135-day PMA supplement is a 30-day notice that FDA converted after review; in the Federal Register notice, 135-day supplements are counted within the 30-day notice submission counts and carry the 30-day notice fee ($10,188 / $5,094) — not the 180-day supplement fee. Budgeting a 135-day supplement at $95,510 overstates it by roughly 9x.
Small Business Discount Ratios
For most submission types (PMA, premarket report, BLA efficacy supplement, panel-track supplement, De Novo, 180-day and real-time supplements, 510(k), and Class III periodic reporting), small business status reduces the user fee to exactly 25% of the standard rate (a 75% discount), per FD&C Act sections 738(d)(2)(C) and (e)(2)(C). Two exceptions and one waiver matter:
- 513(g) Requests for Classification Information and 30-Day Notices: The small business fee is 50% of the standard fee, not 25%.
- First-Time PMA Waiver: A small business with gross receipts (including affiliates) of no more than $30 million is eligible for a 100% waiver of the fee for its first PMA, PDP, PMR, or BLA. It is a one-time benefit, and eligibility is lost permanently once the company or any affiliate has submitted any premarket application — regardless of whether that application was approved.
- Establishment registration hardship waiver: The registration fee has no percentage discount, but FDA may waive it (excluding an initial registration) for a business with gross receipts of $1 million or less that demonstrates financial hardship. Applicants request this in the "Registration & Listing Waiver" section of the Small Business Request and supply supporting documentation.
Historical MDUFA V User Fee Trajectory (FY 2023 – FY 2027)
To contextualize the FY 2027 rates, it is helpful to examine how medical device user fees evolved over the full five-year lifespan of MDUFA V. Authorized under the Food and Drug Administration Reauthorization Act (FDARA) of 2017 and renewed under the Food and Drug Omnibus Reform Act (FDORA) of 2022, MDUFA V set aggregate revenue targets designed to expand FDA review staff, improve digital IT infrastructure, and shorten total review times.
The table below tracks the complete five-year rate progression for key submission types across the MDUFA V cycle:
| Fee Type | FY 2023 | FY 2024 | FY 2025 | FY 2026 | FY 2027 | 5-Year Cumulative Increase |
|---|---|---|---|---|---|---|
| PMA / BLA (Standard) | $441,547 | $483,560 | $540,783 | $579,272 | $636,732 | +44.2% |
| PMA / BLA (Small Business) | $110,387 | $120,890 | $135,196 | $144,818 | $159,183 | +44.2% |
| De Novo Request (Standard) | $132,464 | $145,068 | $162,235 | $173,782 | $191,020 | +44.2% |
| De Novo Request (Small Business) | $33,116 | $36,267 | $40,559 | $43,446 | $47,755 | +44.2% |
| 510(k) Notification (Standard) | $19,870 | $21,760 | $24,335 | $26,067 | $28,653 | +44.2% |
| 510(k) Notification (Small Business) | $4,967 | $5,440 | $6,084 | $6,517 | $7,163 | +44.2% |
| Class III Periodic Reporting (Standard) | $15,454 | $16,925 | $18,927 | $20,275 | $22,286 | +44.2% |
| Establishment Registration | $6,493 | $7,653 | $9,280 | $11,423 | $13,785 | +112.3% |
Source: Compiled from official FDA Federal Register MDUFA rate notices for FY 2023, FY 2024, FY 2025, FY 2026, and FY 2027.
Takeaways from the 5-Year Trajectory
- Every submission fee moved identically (+44.2%): This is not coincidence. Under FD&C Act section 738(a)(2)(A) and (b)(1), every submission fee and the periodic reporting fee is fixed as a percentage of the full premarket application fee — 4.5% for a 510(k), 30% for a De Novo, 3.5% for Class III periodic reporting, and so on. Only the full-fee anchor is adjusted; the rest follow mechanically. Practically: if you know next year's PMA fee, you can compute the entire submission fee table yourself.
- Establishment fees more than doubled (+112.3%): Registration fees rose from $6,493 to $13,785 — a compound annual increase of roughly 20.7% — because they are the only fee type that absorbs the MDUFA V performance improvement, hiring, and operating reserve adjustments, plus any residual gap to the revenue target under section 738(c)(3).
- The cost mix inverted for small companies. In FY 2023 a small business paid $4,967 for a 510(k) versus $6,493 to register one facility — roughly comparable. In FY 2027 a small business 510(k) is $7,163 while registering a single facility is $13,785. For a virtual manufacturer with one registered establishment and one 510(k) a year, the unavoidable fee is now nearly twice the discountable one.
Why Did the Establishment Registration Fee Rise 20.7% When Submission Fees Rose 9.9%?
A frequent source of confusion during annual budget updates is why the annual establishment registration fee grew more than twice as fast as premarket submission fees.
The answer is fully reconstructable from the Federal Register notice, and it is worth walking through because it tells you where fees are heading. The calculation is governed by Section 738 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and runs in a fixed order.
Step 1 — Statutory revenue target. MDUFA V sets the FY 2027 total revenue amount at $418,343,000 before adjustment (section 738(b)(3)).
Step 2 — Inflation. The base inflation adjustment is 60% of the 3-year average change in FDA personnel compensation and benefits per FTE (5.7330% → 3.4398%) plus 40% of the 3-year average change in the Washington-Arlington-Alexandria CPI (2.8330% → 1.1332%), for 4.5730%. Critically, section 738(c)(2)(C)(ii)(II) caps the annual base inflation adjustment at 1.04 — so the 4.573% is trimmed to 4.0%. Compounding that against FY 2026's 1.167391 gives the FY 2027 factor of 1.214087, and an inflation-adjusted revenue target of $507,905,000.
Step 3 — Inflate the base fees. The statutory base fees of $470,000 (premarket application) and $8,465 (establishment registration) × 1.214087 = $570,621 and $10,277.
Step 4 — Close the gap, submission fees first. Applying those inflated fees to the 3-year average submission volumes yields projected collections of $449,060,062 — $58,844,938 short of target. FDA first raises all base fees on a uniform proportionate basis (section 738(c)(2)(D)(ii)). That gets collections to $501,089,079, still $6,815,921 short.
Step 5 — Establishment fees absorb the remainder. Under section 738(c)(3), only the establishment registration fee may be raised further to close the residual. FDA increased it by $225, to $11,693, while the premarket application fee settled at $636,732.
Step 6 — Load the performance improvement adjustment onto registration fees only. FDA met the FY 2025 Pre-Submission Written Feedback goal and the FY 2024 De Novo Decision goal, triggering a performance improvement adjustment of ($40,572,600 + $11,765,400) × 1.214087 = $63,542,885. Section 738(c)(4) directs that this be recovered from establishment registration fees alone. Spread across the 3-year average of 30,380 fee-paying establishment registrations, that adds $2,092 per establishment ($63,542,885 ÷ 30,380 ≈ $2,092), taking the fee from $11,693 to $13,785.
Why This Structure Guarantees the Divergence
Of the $2,362 total increase per establishment, $2,092 (88.6%) is the performance improvement adjustment and only $270 is ordinary inflation plus residual balancing. Registration fees are the designated shock absorber for all three MDUFA V adjustment mechanisms — performance improvement, hiring, and operating reserve — because Congress and industry negotiators wanted submission fees to stay predictable. At the FY 2027 rates, projected establishment registration collections of roughly $418.8 million (30,380 × $13,785) represent about 73% of the $571.4 million FDA expects to collect in total ($507.9M target + $63.5M performance adjustment), up from roughly 70% before the performance adjustment is applied.
The practical consequence for a device company: you cannot manage this cost down through submission strategy. Filing fewer 510(k)s does not reduce it. The only levers are the number of registered establishments you and your contract partners maintain, and — below $1 million in gross receipts — the discretionary hardship waiver.
[!NOTE] Two adjustments did not fire this year. FDA met the FY 2025 statutory hiring threshold of 75 hires, so no hiring adjustment reduced the fee. And estimated end-of-FY 2026 operating reserves of $139,866,752 did not exceed the $190,482,628 designated amount, so no operating reserve reduction applied either. Both are reduction-only mechanisms — had either fired, the establishment fee would have been lower.
Where Does the FY 2027 Establishment Fee Increase Actually Land?
The impact of the establishment fee increase is felt globally across all registered medical device manufacturing, contract sterilization, specification developer, and re-packager facilities.
MedDeviceGuide analysed FDA's public device registration and listing export (the same dataset published through openFDA). The July 2026 export contains 419,651 establishment–product-code listing rows resolving to 25,419 distinct registration numbers across 108 countries. Counting each registration number once and attributing it to its registered country gives the following distribution:
| Rank | Country / Jurisdiction | Registered Establishments | Share | FY 2027 Fees at $13,785 | Added Cost vs. FY 2026 |
|---|---|---|---|---|---|
| 1 | United States | 10,146 | 39.92% | $139.86M | +$23.96M |
| 2 | China | 4,959 | 19.51% | $68.36M | +$11.71M |
| 3 | Germany | 1,077 | 4.24% | $14.85M | +$2.54M |
| 4 | South Korea | 879 | 3.46% | $12.12M | +$2.08M |
| 5 | Canada | 653 | 2.57% | $9.00M | +$1.54M |
| 6 | Taiwan | 617 | 2.43% | $8.51M | +$1.46M |
| 6 | United Kingdom | 617 | 2.43% | $8.51M | +$1.46M |
| 8 | Japan | 531 | 2.09% | $7.32M | +$1.25M |
| 9 | Italy | 518 | 2.04% | $7.14M | +$1.22M |
| 10 | France | 456 | 1.79% | $6.29M | +$1.08M |
| — | Rest of world (98 further countries) | 4,966 | 19.54% | $68.46M | +$11.73M |
| — | All registered establishments | 25,419 | 100% | $350.40M | +$60.04M |
MedDeviceGuide analysis of FDA's device registration and listing export (July 2026 snapshot), multiplied by the official FY 2026 and FY 2027 statutory fee rates. Establishment counts are ours; fee rates are FDA's.
[!IMPORTANT] This is a snapshot, not a collections forecast. The registration and listing export reflects establishments currently listed at a point in time (25,419). FDA sets fees using a different figure — the 3-year average of 30,380 fee-paying establishment registrations across FY 2023–FY 2025, which implies roughly $418.8 million in FY 2027 registration collections rather than the $350.4 million in the table. The gap exists because the public export excludes registrations that lapsed, were never renewed, or are otherwise not reflected at export time. Use the table for relative geographic exposure, not for modelling FDA's revenue.
What the Distribution Actually Tells You
- Nearly 60% of the increase lands outside the United States. U.S. establishments absorb $23.96M of the $60.04M snapshot increase; the other $36.08M falls on foreign facilities that have no vote in MDUFA negotiations and, in most cases, no U.S. tax return to support a small business request.
- China's exposure is concentrated in contract manufacturing. With 4,959 registrations — nearly one in five worldwide — Chinese facilities carry $11.71M of the increase. For a U.S. specification developer using three Chinese contract manufacturers, that increase is passed through commercially even though the U.S. company never sees the invoice.
- Establishment type matters more than headcount. The same export records 41,763 declared activities across those 25,419 establishments — one establishment can declare several, so these figures overlap and must not be summed. The largest are "Manufacture Medical Device" (16,401 establishments), "Manufacture Medical Device for Another Party / Contract Manufacturer" (7,233), "Develop Specifications But Do Not Manufacture At This Facility" (5,100), and "Sterilize Medical Device for Another Party / Contract Sterilizer" (571). The fee attaches to the establishment, not the activity — so a virtual manufacturer that registers as a specification developer and uses two contract manufacturers and one contract sterilizer is generating four separate $13,785 obligations across its supply chain, of which it pays one directly.
Because the establishment registration fee has no small business percentage reduction — only the discretionary hardship waiver for businesses at or below $1 million in gross receipts — early-stage and virtual manufacturers must verify that contract partners remain in good standing. Annual registration renewal runs October 1 through December 31, and the FY 2027 fee must be paid before the renewal can be completed. A partner that fails to renew becomes an unregistered establishment, which can lead to detention without physical examination (DWPE) for imported components or finished devices.
Combination Products: CDRH vs. CBER vs. CDER User Fee Assignment
For medical device companies developing combination products—such as drug-eluting stents, pre-filled auto-injectors, wound dressings with antimicrobial agents, or antibody-coated diagnostic cartridges—determining which user fee schedule applies requires understanding FDA center assignment rules under 21 CFR Part 3.
[COMBINATION PRODUCT DESIGNATION (21 CFR Part 3)]
│
[PRIMARY MODE OF ACTION (PMOA) DETERMINATION]
│
┌────────────────────────────────────┼────────────────────────────────────┐
│ │ │
[DEVICE PMOA -> CDRH] [DRUG PMOA -> CDER] [BIOLOGIC PMOA -> CBER]
• Fee statute: MDUFA V • Fee statute: PDUFA VII • PDUFA, BsUFA or MDUFA
• 510(k): $28,653 • NDA w/ clinical: $4,600,753 • 351(a) BLA: $4,600,753
• De Novo: $191,020 • NDA no clinical: $2,300,376 • 351(k) biosim: $1,124,936
• PMA: $636,732 • Program fee: $416,857 • Device-type BLA: $636,732
Key Rules for Combination Product Fees
- Primary Mode of Action (PMOA): The product's PMOA determines which FDA Center takes lead jurisdiction, resolved through a Request for Designation (RFD) under 21 CFR Part 3 where it is not obvious.
- CDRH Lead (Device PMOA): A catheter with a secondary heparin coating is submitted as a 510(k) or PMA and pays MDUFA V fees ($28,653 / $636,732 for FY 2027).
- CDER Lead (Drug PMOA): A pre-filled epinephrine auto-injector, where the drug is the PMOA, is submitted as an NDA and pays PDUFA VII fees — $4,600,753 for FY 2027 where covered clinical data is required, or $2,300,376 where it is not, plus a $416,857 annual program fee per prescription drug product.
- CBER Lead (Biologic PMOA): A therapeutic biologic-device combination filed as a 351(a) BLA pays the PDUFA rate; a biosimilar filed as a 351(k) BLA pays the BsUFA rate ($1,124,936 for FY 2027 with clinical data). A BLA for a product regulated under the device authorities — blood grouping reagents, donor screening assays, blood establishment computer software — sits in the MDUFA table at $636,732.
The Cross-Program Comparison Nobody Publishes
FY 2027 is the year the trend lines crossed. FDA published all four user fee programs on July 30, 2026, and device fees were the outlier:
| Program | FY 2026 headline application fee | FY 2027 | Change |
|---|---|---|---|
| MDUFA (PMA / full-fee device application) | $579,272 | $636,732 | +9.9% |
| MDUFA (establishment registration) | $11,423 | $13,785 | +20.7% |
| PDUFA (application requiring clinical data) | $4,682,003 | $4,600,753 | −1.7% |
| PDUFA (program fee) | $442,213 | $416,857 | −5.7% |
| BsUFA (application requiring clinical data) | $1,200,794 | $1,124,936 | −6.3% |
Drug and biosimilar fees fell while device fees rose sharply. The reason is structural rather than political: PDUFA and BsUFA divide a target revenue amount across a rolling estimate of fee-paying applications, so rising submission volume pushes the per-application fee down. MDUFA sets each submission fee as a fixed percentage of a statutory base that only moves up with inflation, and then routes every remaining revenue requirement to establishment registration. For a combination product developer choosing a filing strategy, this means device-side fee inflation is not a temporary anomaly — it is how the statute is built.
Should We File Before September 30, 2026, or After October 1, 2026?
Medical device companies preparing 510(k) notifications, De Novo submissions, or PMA supplements in late summer face a crucial tactical decision: Should you rush to file before FY 2026 ends on September 30, 2026, or wait for FY 2027?
To determine the optimal submission window, regulatory teams must evaluate three parameters: user fee savings, small business status timing, and submission completeness.
[IS SUBMISSION NEARLY READY IN AUGUST / SEPTEMBER?]
│
┌────────────────────────┴────────────────────────┐
YES NO
│ │
[DO YOU HAVE VALID FY2026 SBD?] [FILE FY2027 SBR NOW — WINDOW IS OPEN]
│ │ │
YES NO [ALLOW 60 DAYS BEFORE FEE IS DUE]
│ │ │
┌────────┴────────┐ [FY2026 SBR WINDOW CLOSED [FILE AFTER OCT 1 AT FY2027 RATES]
│ RUSH TO FILE │ 1 AUG 2026 — NO NEW • 510(k): $7,163 (SBD) / $28,653
│ BEFORE SEPT 30 │ FY2026 STATUS AVAILABLE] • De Novo: $47,755 (SBD) / $191,020
│ • 510(k): $6,517│ │
│ • Standard: │ [FILE AT FY2026 STANDARD RATE, OR WAIT
│ $26,067 │ FOR FY2027 SBD AND FILE IN OCTOBER]
└─────────────────┘
Financial Comparison: Rushing vs. Waiting
| Submission | FY 2026 (file by Sep 30) | FY 2027 (file from Oct 1) | Saved by filing early | Saved (small business) |
|---|---|---|---|---|
| 510(k) | $26,067 | $28,653 | $2,586 | $646 |
| De Novo | $173,782 | $191,020 | $17,238 | $4,309 |
| 180-day PMA supplement | $86,891 | $95,510 | $8,619 | $2,155 |
| Panel-track supplement | $463,418 | $509,386 | $45,968 | $11,492 |
| PMA / PDP / PMR / BLA | $579,272 | $636,732 | $57,460 | $14,365 |
The Decision Rule
The saving is real but small relative to the downside, and it scales very differently by pathway. Use this rule:
- Small business 510(k): do not rush. $646 is roughly one hour of a regulatory consultant's time plus change. Nothing about a 510(k) is worth a compressed final review for that.
- Standard-fee 510(k): rush only if the file is submission-ready today. $2,586 does not justify skipping a verification report review.
- De Novo and PMA: rush is worth planning around, not improvising around. $17,238 to $57,460 is material — but a De Novo or PMA that arrives incomplete costs far more in review-clock time than the fee delta.
- If you do not already hold FY 2026 small business status, the rush decision is settled for you. The FY 2026 Small Business Request window closed on August 1, 2026. A company without FY 2026 status can no longer obtain it, so its choice is "file now at the FY 2026 standard rate" versus "obtain FY 2027 status and file in October at the FY 2027 small business rate." For a 510(k) that comparison is $26,067 now versus $7,163 in October — waiting saves $18,904, and the same logic holds, far more dramatically, for a De Novo ($173,782 versus $47,755).
The Hidden Risk: Premature File Rejection
Under FDA's Refuse-to-Accept (RTA) policy for 510(k)s and acceptance/filing review for PMAs, a submission sent on September 28 to catch the FY 2026 rate but failing the acceptance checklist for missing test reports or formatting gaps goes on RTA hold. If the file is subsequently withdrawn and resubmitted after October 1, the replacement is assessed at the FY 2027 rate — so the rushed filing bought nothing and cost a review cycle.
There is a second, quieter trap. The fee is due upon submission, and FDA places a submission on user fee hold until the correct payment is matched to the cover sheet. A submission uploaded on September 29 whose wire transfer does not clear until October 2 is not logged in as received in FY 2026. Payment timing, not upload timing, is what closes the fiscal-year window in practice — so if you are filing in the last week of September, pay by credit card or confirm the wire has cleared before you rely on the FY 2026 rate.
How Do We Qualify or Requalify as a Small Business for FY 2027?
The FDA Small Business Determination (SBD) program grants substantial fee discounts (75% off most submissions) to qualifying medical device companies. However, small business status does NOT roll over automatically from year to year. Per FDA's Small Business Qualification and Determination guidance, a determination is granted for a single fiscal year and expires at the end of it; a sponsor must apply and be granted an SBD for each fiscal year in which it plans to file a fee-bearing submission.
[!IMPORTANT] The FY 2027 window is already open, and the FY 2026 window is closed. FDA's SBD program page states that the FY 2026 MDUFA Small Business Request (SBR) window closed on August 1, 2026 at 4:00 PM ET, and the FY 2027 window opened on August 1, 2026 at 4:01 PM ET. Requests submitted before that moment are not accepted for FY 2027. In practice, the FY 2027 request window runs from 1 August 2026 to 1 August 2027.
The Three Thresholds — They Are Not the Same Number
This is the single most common source of error. MDUFA defines "small business" three different ways depending on which benefit you are seeking:
| Benefit sought | Gross receipts ceiling (including all affiliates) | What you get |
|---|---|---|
| Reduced application fees | ≤ $100 million | 25% of standard fee (50% for 513(g) and 30-day notice) |
| First premarket application / report fee waiver | ≤ $30 million | $0 on the first PMA, PDP, PMR or BLA — one time only, forfeited permanently once the company or any affiliate has submitted any premarket application |
| Annual registration fee waiver | ≤ $1 million | Discretionary waiver of the $13,785 registration fee (excluding initial registration), on demonstrated financial hardship |
Step-by-Step Requalification Process
Step 1: Gather signed tax returns
└─ Complete, signed U.S. Federal income tax returns for the most recent tax year, for the
applicant AND every U.S. affiliate. Foreign businesses and foreign affiliates instead
need a National Taxing Authority Certification (Section III of Form FDA 3602N).
Step 2: Complete Form FDA 3602N (MDUFA Small Business Request)
└─ FDA consolidated the former Form FDA 3602 (domestic) and Form FDA 3602A (foreign)
into a single webform, FDA 3602N. Since 1 November 2024 all Small Business Requests
must be submitted electronically.
Step 3: Aggregate affiliate revenue
└─ Sum worldwide gross receipts of parents, subsidiaries and commonly controlled entities.
Undisclosed affiliates are the most frequent cause of denial.
Step 4: Submit the SBR through the CDRH Customer Collaboration Portal
└─ There is no fee for a Small Business Request. If you are also seeking the registration
fee waiver, complete the "Registration & Listing Waiver" section and attach hardship
documentation.
Step 5: Receive your FY 2027 small business decision and organization number
└─ Enter it on the Medical Device User Fee Cover Sheet before you generate a payment
identification number (PIN) and pay.
Crucial Lead-Time Planning
The statute requires that evidence of qualification be submitted at least 60 days before the fee at issue is due (FD&C Act sections 738(a)(3)(B)(ii)(V), 738(d)(2)(D) and 738(e)(2)(D)). Actual turnaround in practice is often far faster, but 60 days is the number to plan against, not the number to gamble on.
- If you intend to file a 510(k) or De Novo on October 1, 2026, your FY 2027 SBR should be in the CDRH Portal by early August 2026.
- If you submit a premarket application before FDA has qualified you as a small business, you must pay the full standard fee for that submission — FDA's guidance is explicit on this point. Approval granted afterwards does not convert the already-received submission to the reduced rate.
User Fee Refunds, Appeals, and Dispute Resolution
If an applicant pays a user fee and the submission is subsequently refused, withdrawn, or cancelled, the refund rules sit in FD&C Act section 738(a)(2)(D) (21 U.S.C. 379j(a)(2)(D)). They are more restrictive than most budget models assume.
Refund Eligibility Rules — What the Statute Actually Says
| Scenario | Statutory outcome |
|---|---|
| Application, report, or supplement refused for filing | FDA shall refund 75% of the fee |
| Withdrawn before FDA's filing decision | FDA shall refund 75% of the fee |
| Withdrawn after filing but before a first action | FDA may return some or all — the amount, if any, is based on the level of review effort already expended. There is no guaranteed percentage. |
| Modular PMA withdrawn before a second module is submitted and before first action | FDA shall refund 75% |
| Modular PMA withdrawn after a second or later module but before first action | FDA may return a portion, based on effort expended |
The practical consequences are worth stating plainly. First, there is no statutory refund at all once FDA has taken a first action — a 510(k) that receives an Additional Information request is unrecoverable. Second, the "withdrawn after filing but before first action" case is discretionary and unquantified: budgeting a 75% recovery there is a modelling error. Third, a refused-for-filing 510(k) recovers $21,490 of a $28,653 standard fee (or $5,372 of a $7,163 small business fee) — and the resubmission is charged in full at the then-current rate.
The 180-Day Clock
Per Section X of the FY 2027 rate notice, to qualify for consideration for a refund a person must submit a written request to FDA not later than 180 days after the fee is due. Note the trigger: the date the fee was due, not the date you paid it. Because the fee is due upon submission, an applicant who paid early and withdrew late can burn through the window sooner than expected.
Small Business Determination Denials
An SBD denial is not a refund question — it is a qualification question, and the practical remedy is to correct the submission. The overwhelmingly common cause is an undisclosed affiliate: gross receipts of every parent, subsidiary, and commonly owned entity count toward the threshold, and FDA reconciles the tax returns you supply against the affiliate structure you declare. If the denial rests on a factual error, supply the corrected returns or National Taxing Authority Certification through the CDRH Portal; FDA's general internal agency review mechanism under 21 CFR 10.75 remains available for formal disputes.
Which Submissions Carry No MDUFA Fee at All?
Not every regulatory interaction with CDRH or CBER requires a user fee payment. Medical device companies can optimize their regulatory spending by leveraging fee-exempt pathways:
Statutory Exceptions Under FD&C Act Section 738(a)(2)(B)
The statute itself carves out five categories:
- Humanitarian Device Exemption (HDE) applications: An application under section 520(m) is not subject to any premarket fee. (The establishment registration fee still applies.)
- BLA for a product licensed for further manufacturing use only: No premarket application fee.
- State or Federal Government sponsors: No fee for a premarket application, premarket report, supplement, 510(k), or De Novo submitted by a U.S. state or federal government entity — unless the device is to be distributed commercially.
- 510(k)s reviewed by an accredited third party: No FDA user fee for a 510(k) reviewed by an accredited person under section 523. (The third-party reviewer charges its own fee, which is frequently comparable.)
- Pediatric conditions of use: No fee for a premarket application, premarket report, 510(k), or De Novo whose proposed conditions of use are solely for a pediatric population, or for a supplement whose sole purpose is to propose pediatric conditions of use.
Two Submissions That Carry No Fee Because They Are Not in the Fee Table
- Pre-Submissions and other Q-Submissions: Pre-Subs, Informational Meetings, Study Risk Determinations, and Submission Issue Meetings carry no MDUFA fee at all.
- Investigational Device Exemptions (IDEs): Original IDEs, IDE supplements, and IDE annual reports are not fee-bearing submission types.
[!WARNING] Two traps in the exemption list. First, the 513(g) request for classification information is not covered by the pediatric exemption — a pediatric-only device still pays $8,596 (or $4,298) to ask FDA a classification question. Second, if you take the pediatric exemption and later submit a supplement proposing adult conditions of use, that supplement is charged at the fee then in effect for an original PMA, not at a supplement rate. The pediatric exemption defers cost; it does not always eliminate it.
Strategic Use of Pre-Submissions
Because Pre-Submissions carry no user fee, companies planning a De Novo request or complex 510(k) should routinely use a Q-Sub to align with FDA on bench testing protocols, clinical evidence expectations, and predicate selection before filing the paid premarket submission. The economics are stark: a Pre-Sub costs $0 and, per the statutory refund rules above, a De Novo that reaches a first action and then fails recovers nothing of its $191,020.
Frequently Asked Questions (FAQ)
Is the small business fee always a quarter of the standard fee?
Almost, but not always. For most submissions — 510(k), De Novo, PMA, premarket report, BLA efficacy supplement, panel-track supplement, 180-day and real-time supplements, and Class III periodic reporting — the small business fee is exactly 25% of the standard fee (a 75% discount). It is 50% for 513(g) requests for classification information ($4,298 vs. $8,596) and 30-day notices ($5,094 vs. $10,188). The establishment registration fee has no percentage reduction at all.
Does the establishment registration fee have a small business rate?
There is no rate reduction — every registered establishment is billed $13,785 for FY 2027. There is, however, a waiver. The FY 2027 Federal Register notice states that FDA "may, but is not required to, grant a waiver of the annual establishment registration fee (excluding the initial registration)" to a qualified small business that demonstrates the fee represents a financial hardship. For this specific waiver, the gross receipts ceiling is $1 million or less — far below the $100 million threshold used for application fee reductions — and applicants request it through the Registration & Listing Waiver section of Form FDA 3602N with supporting documentation. It is discretionary, granted once in relation to the circumstances that gave rise to it, and should not be assumed in a budget.
When do we pay the FY 2027 annual establishment registration fee?
Annual registration renewal runs October 1 through December 31, 2026, and the FY 2027 fee must be paid before the renewal can be completed. Payment is made by first obtaining a Device Facility User Fee (DFUF) order and payment identification number from FDA, paying it, and then entering the DFUF PIN and payment confirmation number when updating the establishment's registration. FDA opens FY 2027 DFUF ordering ahead of the October 1 renewal window; check FDA's "When to Register and List" page for the exact opening date rather than assuming it.
Does a first-application fee waiver also waive the establishment registration fee?
No. The first premarket application waiver applies to a single PMA, PDP, PMR, or BLA for a qualifying small business with gross receipts of $30 million or less. It has no effect on the annual $13,785 establishment registration fee, which is governed by a separate — and much lower — $1 million hardship threshold.
What happens to our fee rate if payment clears after October 1, 2026?
The fee is due upon submission, and FDA will not log a submission in as received until the correct payment has been matched to the user fee cover sheet; until then the submission sits on user fee hold. So if a 510(k) is uploaded on September 29, 2026 but the wire transfer does not clear until October 2, the submission is not received in FY 2026 and the FY 2027 rate ($28,653 standard / $7,163 small business) applies. The same happens if payment is rejected because an expired FY 2026 small business organization number was entered on the cover sheet. If you are filing in the final week of September, use a payment method that settles immediately and confirm receipt before relying on the FY 2026 rate.
We have six approved PMAs and file nothing new next year. What do we owe?
More than most teams budget. Class III periodic reporting is an annual fee of $22,286 per approved PMA, PDP, or PMR in FY 2027 — $133,716 for six — plus $13,785 for every registered establishment. A company that files no new submission at all can still carry a six-figure MDUFA bill.
Strategic Action Items for FY 2027 Budgeting
To ensure seamless regulatory operations and avoid cost overruns in FY 2027, medtech leadership teams should execute the following checklist:
- Submit the FY 2027 Small Business Request now. The window opened 1 August 2026. Complete Form FDA 3602N through the CDRH Portal with signed tax returns for the applicant and every affiliate (and National Taxing Authority Certifications for foreign entities). Plan against the statutory 60-day lead time. There is no fee for the request itself.
- Audit pending submissions against the rush rule. For files slated for August–October 2026, apply the decision rule above: rush only if the submission is genuinely complete, and confirm payment settles before September 30 — payment timing, not upload timing, sets the fiscal year.
- Count your establishments, not just your submissions. Establishment registration is now the largest unavoidable line for most small manufacturers. List every registration number you or your contract partners hold, multiply by $13,785, and check whether any entity qualifies for the $1 million hardship waiver.
- Add Class III periodic reporting to the recurring budget. At $22,286 per approved PMA/PDP/PMR per year, this is a standing obligation that grows with your approved portfolio, not with your filing activity.
- Verify contract partner registration status in FDA's device registration and listing database so partners renew and pay before December 31, 2026 and avoid detention without physical examination on imports.
- Leverage non-fee pathways. Q-Sub Pre-Submissions and IDEs carry no MDUFA fee — use them to resolve protocol and predicate questions before committing capital to a paid premarket application that, past a first action, is non-refundable.
Related Guides & Deep Dives
For further analysis of U.S. FDA regulatory pathways, medical device cost modeling, and global market access fees, explore our related knowledge base resources:
- MDUFA V 510(k) fee schedule and total cost breakdown — Prior-year fee structures, consultant rates, testing costs, and total 510(k) budgeting models.
- FY 2026 MDUFA fee schedule and small business planning — Historical baseline fees and year-over-year growth context under MDUFA V.
- MDUFA VI reauthorization negotiation priority themes — Outlook for MDUFA VI negotiations covering FY 2028 through FY 2032.
- Global medical device registration and establishment cost comparisons — Cross-jurisdictional analysis comparing FDA user fees with EU Notified Body, NMPA China, and PMDA Japan official fees.