The U.S. Food and Drug Administration (FDA) has published the medical device user fee rates for fiscal year 2027, setting the amounts manufacturers, applicants, and registered establishments will owe for submissions and annual registration between October 1, 2026, and September 30, 2027.
The notice, published in the Federal Register, implements authority granted under the Medical Device User Fee Amendments of 2022 (MDUFA V) and carries direct financial implications for companies with active or planned device programs in the U.S. market.
For any company preparing a premarket approval application (PMA), managing an established device portfolio, or operating a registered manufacturing site, understanding these fee rates is a practical planning requirement. The new rates apply across multiple submission types and annual obligations, and small businesses may qualify for meaningful reductions if they act within the prescribed windows.
Statutory Framework and Total Revenue Target
MDUFA V, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act), authorizes FDA to collect user fees tied to specific regulatory activities. Section 738 of the FD&C Act (21 U.S.C. 379j) governs fees for applications, supplements, periodic reports on class III devices, and annual establishment registration. The statute prescribes fee amounts for each fiscal year from FY 2023 through FY 2027, making FY 2027 the final year of the current MDUFA V authorization cycle.
The statutory total revenue target for FY 2027 is $418,343,000, before inflation adjustment. FDA uses this figure as the starting point for calculating individual fee rates, then applies required inflation and performance-based adjustments to arrive at the fees actually owed.
Key Fee Amounts for FY 2027
The FD&C Act specifies a statutory base fee of $470,000 for a premarket application (covering PMAs, product development protocols, and biologics license applications) and $8,465 for establishment registration. These base figures are only the starting point of FDA’s calculation. After applying the required inflation adjustment and the MDUFA V performance improvement adjustment, the standard fees that actually apply for FY 2027 are set out below.
| Application Fee Type | Fee as % of Standard PMA Fee | FY 2027 Standard Fee | FY 2027 Small Business Fee |
| Premarket Application (PMA/PDP/BLA) | Base fee, set in statute | $636,732 | $159,183 |
| Premarket Report | 100% | $636,732 | $159,183 |
| Efficacy Supplement | 100% | $636,732 | $159,183 |
| Panel-Track Supplement | 80% | $509,386 | $127,347 |
| De Novo Classification Request | 30% | $191,020 | $47,755 |
| 180-Day Supplement | 15% | $95,510 | $23,878 |
| Real-Time Supplement | 7% | $44,571 | $11,143 |
| 510(k) Premarket Notification | 4.5% | $28,653 | $7,163 |
| 30-Day Notice | 1.6% | $10,188 | $5,094 |
| 513(g) Classification Request | 1.35% | $8,596 | $4,298 |
| Annual Periodic Reporting (Class III) | 3.5% | $22,286 | $5,572 |
| Annual Establishment Registration | Base fee, set in statute | $13,785 | $13,785 |
For most submission types, qualified small businesses pay 25% of the standard fee. The exceptions are 30-day notices and 513(g) requests, where the small business rate is 50% of the standard fee instead. Establishment registration does not carry a reduced small business rate; the fee is uniform, though a separate discretionary waiver exists (covered below).
The full fee schedule, along with FDA’s calculation methodology, is available in the official Federal Register notice.
Small Business Fee Reductions and Waivers
Under sections 738(d) and 738(e) of the FD&C Act, qualified small businesses may be eligible for reduced user fees or, in some cases, a waiver. These provisions are not automatic. A company must submit a completed MDUFA Small Business Request form along with supporting financial documentation at least 60 days before any applicable fee is due, and the determination must be in place before the submission is received.
Businesses with gross receipts or sales of $100 million or less may qualify for reduced fees. Businesses with $30 million or less may also qualify for a waiver of the fee for their first premarket application or premarket report. A separate, more limited waiver exists for the establishment registration fee: FDA may, but is not required to, waive it for a small business (defined here as $1 million or less in gross receipts) if paying represents a financial hardship, as determined by FDA. Small business status must be re-established annually and does not carry over automatically from the prior fiscal year.
Missing the qualification window means paying the standard fee rate, and retroactive adjustments are not available once a submission has been received and the fee collected.
What This Means for Your Business
At $636,732 for a standard PMA, fee amounts at the higher end of the schedule represent a material cost that belongs in project budgets alongside clinical, regulatory, and manufacturing costs. Companies managing multiple submission types in the same fiscal year will need to account for cumulative fee obligations, including any applicable supplement or periodic reporting fees. Establishments that expanded their manufacturing footprint or registered new sites should confirm that each registered site is budgeted at the $13,785 annual registration rate.
Since FY 2027 is the final year under MDUFA V, companies should also watch for activity from Congress on the next user fee reauthorization. A lapse in MDUFA authorization could affect FDA’s review timelines and capacity, which would have downstream effects on submission planning. Monitoring the status of those negotiations is worthwhile for any company with multi-year device development timelines.
For companies uncertain about their small business eligibility or which fee category applies to a planned submission, our FDA medical device compliance services can help with fee classification and structuring submissions to avoid unnecessary costs.
Frequently Asked Questions
Does the $636,732 premarket application fee apply to all device submissions?
No. The $636,732 standard fee applies specifically to premarket applications: PMAs, PDPs, and BLAs. Other submission types, such as 510(k) premarket notifications and De Novo requests, are set at specified percentages of that standard fee and carry lower costs. Companies should confirm which submission pathway applies to their device before assuming a fee tier, since the distinction between a PMA and a 510(k) pathway reflects the level of regulatory scrutiny the device is subject to, not just a cost difference.
If a company registers a new manufacturing site mid-year, does it owe a partial registration fee?
No. The establishment registration fee is an annual flat fee, not prorated based on when in the fiscal year a site registers. For FY 2027, every establishment subject to section 510 registration requirements owes $13,785 regardless of when it registers during the October 1, 2026 to September 30, 2027 period. Companies opening new facilities should factor the full annual fee into their budgets from the point of registration.
How does a company apply for small business status before a submission deadline?
Submit a completed MDUFA Small Business Request form along with supporting financial documentation at least 60 days before any applicable fee is due. Qualification is not automatic based on company size alone, and the determination must be finalized before FDA receives the relevant submission; companies cannot retroactively claim the reduced fee after a standard fee has been assessed and accepted. Companies with gross receipts of $30 million or less may also qualify for a separate first-PMA fee waiver under section 738(d).
Key Takeaways
- FDA has published the medical device user fee rates for fiscal year 2027, effective October 1, 2026 through September 30, 2027, under MDUFA V.
- The standard premarket application fee is $636,732, and the annual establishment registration fee is $13,785 per site, after required inflation and performance-based adjustments to the statutory base fees.
- Small businesses may qualify for reduced fees (generally 25% of the standard fee) or waivers under sections 738(d) and 738(e), but must apply at least 60 days before their submission is received.
- FY 2027 is the final year under MDUFA V, making it worth tracking Congressional reauthorization activity for any impact on FDA review capacity.
Planning Ahead on FY 2027 Device Fees
With the fee schedule finalized and the fiscal year start date of October 1, 2026 approaching, device companies should confirm their submission plans, assess their registration obligations, and determine whether they qualify for small business reductions. If you would like to discuss how the FY 2027 fee schedule applies to your device portfolio or submission strategy, contact us to speak with our team.
