FDA User Fees 2026: Complete MDUFA Fee Schedule, Small Business Program & Strategic Planning Guide

Understanding FDA Medical Device User Fees

Every medical device manufacturer that submits applications to the FDA or registers an establishment in the United States must pay user fees under the Medical Device User Fee Amendments (MDUFA). These fees fund the FDA's device review operations and directly impact your regulatory budget.

For FY 2026 (October 1, 2025 through September 30, 2026), the FDA published updated fee rates in a Federal Register notice on July 30, 2025. The most notable change: the annual establishment registration fee increased 23% from $9,280 to $11,423, while submission fees rose approximately 7% across the board.

This guide covers every fee category, explains the small business program in detail, and provides strategic planning advice to minimize your costs.

FY 2026 Complete Fee Schedule

Application Fees

Application Type	Standard Fee	Small Business Fee	FY 2025 Standard	YoY Change
510(k)	$26,067	$6,517	$24,335	+7.1%
513(g)	$7,820	$3,910	$7,301	+7.1%
PMA, PDP, PMR, BLA	$579,272	$144,818	$540,783	+7.1%
De Novo Classification	$173,782	$43,446	$162,235	+7.1%
Panel-track supplement	$463,418	$115,855	$432,626	+7.1%
180-day supplement	$86,891	$21,723	$81,117	+7.1%
Real-time supplement	$40,549	$10,137	$37,855	+7.1%
BLA efficacy supplement	$579,272	$144,818	$540,783	+7.1%
30-day notice	$9,268	$4,634	$8,653	+7.1%
Annual periodic reporting (Class III)	$20,275	$5,069	$18,932	+7.1%

Annual Registration Fee

Fee Type	FY 2026	FY 2025	YoY Change
Annual Establishment Registration	$11,423	$9,280	+23.1%

The establishment registration fee applies to all establishments that must register with the FDA. There is no small business reduction for this fee (though a new waiver program is available — see below).

When Are Fees Due?

Fee Type	Payment Deadline	Consequences of Non-Payment
Establishment registration	October 1 – December 31 annually	Registration becomes inactive; cannot submit new applications or import devices
510(k) / De Novo / PMA	Before FDA begins review	Submission placed on "User Fee Hold" — review clock does not start
Periodic reporting (Class III)	Billed by FDA annually	Late payment may result in withdrawal action

Important: If paying by credit card, allow several extra business days for the payment to clear. The FDA will not begin reviewing your submission until the fee payment is confirmed in their system.

The Small Business Determination (SBD) Program

The FDA's Small Business Determination (SBD) Program provides significant fee reductions for qualifying companies. Understanding this program is one of the most impactful ways to reduce your regulatory costs.

Three Tiers of Savings

1. Reduced Application Fees (≤$100M Revenue)

Companies with gross receipts or sales of $100 million or less (including affiliates) qualify for reduced fees at 25% of the standard rate for most submission types.

Application	Standard	Small Business	Savings
510(k)	$26,067	$6,517	$19,550
De Novo	$173,782	$43,446	$130,336
PMA	$579,272	$144,818	$434,454

2. First PMA/BLA Fee Waiver (≤$30M Revenue)

Companies with gross receipts or sales of $30 million or less (including affiliates) qualify for a one-time waiver of the first PMA, PDP, PMR, or BLA fee. This can save up to $579,272 for a standard PMA.

Key rules:

• The waiver applies only to the first PMA/BLA/PDP/PMR ever submitted by the business entity or any of its affiliates
• 510(k) and De Novo submissions do not count toward this waiver
• The waiver cannot be transferred or sold

3. Establishment Registration Fee Waiver (NEW in FY 2026)

For the first time ever, the FDA may grant a waiver of the annual establishment registration fee for qualifying small businesses. To be eligible, a business must meet all three criteria:

1. Gross receipts or sales of $1 million or less (including affiliates)
2. Demonstrate that paying the fee represents financial hardship (e.g., proof of active bankruptcy)
3. Provide proof of prior year's payment of the registration fee

Important caveats:

• This waiver is discretionary — the FDA is not required to grant it
• It does not apply to initial registration — only renewals
• It is evaluated on a case-by-case basis
• Startups should plan to pay the full $11,423 unless explicitly granted relief

How to Apply for Small Business Status

Timing: The FDA accepts Small Business Requests from August 1 through September 30 of the fiscal year for which you are seeking status. For FY 2026, requests were accepted from August 1, 2025 through September 30, 2026.

Process:

1. Submit a Small Business Request through the CDRH Portal
2. Include your most recent Federal (US) income tax return showing gross receipts/sales
3. Include tax returns for all affiliates
4. There is no fee to submit a Small Business Request
5. FDA will notify you through the portal of the determination

For actively registered firms seeking the registration fee waiver: FDA accepts requests through October 31 of the fiscal year.

What Counts as an "Affiliate"?

The FDA considers affiliates to include any entity that directly or indirectly controls, is controlled by, or is under common control with your business. This includes:

• Parent companies
• Subsidiaries
• Sister companies under common ownership
• Foreign affiliate entities

All affiliate revenue is aggregated when determining your eligibility threshold.

Which Fees Apply to Which Submissions?

510(k) Fees

510(k) Type	User Fee Applies?	Small Business Fee?
Traditional 510(k)	Yes	Yes
Special 510(k)	Yes	Yes
Abbreviated 510(k)	Yes	Yes
Third-party reviewed 510(k)	No	No
Exempt submission	No	N/A

Tip: If your device qualifies for third-party review, you can avoid the 510(k) user fee entirely. The FDA authorizes recognized third parties to review certain Class I and II devices.

PMA Fees

PMA Type	User Fee Applies?	Small Business Fee?
Original PMA	Yes	Yes
Panel-track supplement	Yes	Yes
180-day supplement	Yes	Yes
Real-time supplement	Yes	Yes
30-day notice	Yes	Yes
Manufacturing/sterilization site change	No	No
Special PMA supplement (changes being effected)	No	No
Trade name supplement	No	No

De Novo Fees

De Novo Type	User Fee Applies?	Small Business Fee?
Original De Novo request	Yes	Yes
Exempt submission	No	N/A

Exemptions from All Fees

The following submissions are exempt from user fees:

• Applications from State or Federal government entities (unless the device is to be distributed commercially)
• Third-party reviewed 510(k)s
• Any submission that meets criteria for a statutory exemption

Strategic Planning: How to Minimize Your FDA User Fees

Strategy 1: Qualify for Small Business Status

If your company has ≤$100M in gross revenue (including affiliates), applying for SBD status should be your first step. The savings are substantial:

• 510(k): Save $19,550 per submission
• De Novo: Save $130,336 per submission
• PMA: Save $434,454 per submission

Action: Submit your Small Business Request via the CDRH Portal as early as August 1 each year.

Strategy 2: Use the First PMA Waiver Strategically

If your company qualifies (≤$30M revenue including affiliates), you get one opportunity to waive the full PMA fee ($579,272). Use it wisely:

• Don't waste it on a PMA that could be a 510(k) or De Novo
• Time it for your most commercially important Class III device
• The waiver applies to your first PMA ever — plan your pipeline accordingly

Strategy 3: Leverage Third-Party Review

For eligible Class I and II devices, third-party review eliminates the 510(k) user fee entirely. Recognized third parties include organizations like BSI, TUV SUD, DEKRA, and others authorized by the FDA.

Savings: Up to $26,067 per submission (though third-party review firms charge their own fees).

Strategy 4: Plan Around the Fiscal Year Calendar

MDUFA fees reset every October 1. Key planning considerations:

• Submit before October 1 if fees are expected to increase (they typically do)
• Pay establishment registration early (October–December window) to avoid disruptions
• Time your PMA submission to maximize use of SBD status within a fiscal year

Strategy 5: Combine Submissions When Possible

If you have multiple devices requiring 510(k) submissions:

• Consider whether a single 510(k) can cover multiple devices (if they are variants or accessories)
• Each separate 510(k) requires its own fee — $26,067 each at standard rate

Strategy 6: Budget for the Full Cost, Not Just User Fees

User fees are only one component of your regulatory budget. Plan for:

Cost Component	Typical Range
FDA user fee (510(k))	$6,517–$26,067
Regulatory consulting	$17,500–$75,000
Testing (bench, biocompatibility, EMC)	$20,000–$150,000
Clinical data (if needed)	$50,000–$5,000,000+
US Agent (foreign manufacturers)	$1,000–$5,000/year
Establishment registration	$11,423/year
Total 510(k) project	$50,000–$250,000+

Year-Over-Year Fee Trends

FDA user fees have increased consistently under MDUFA. Here is the 5-year trend for key fees:

Fee Type	FY 2022	FY 2023	FY 2024	FY 2025	FY 2026
510(k) standard	$12,745	$19,870	$21,760	$24,335	$26,067
PMA standard	$365,657	$441,547	$483,472	$540,783	$579,272
De Novo standard	$109,697	$132,464	$145,042	$162,235	$173,782
Establishment registration	$5,672	$6,493	$8,073	$9,280	$11,423

Key observations:

• The 510(k) fee has more than doubled since FY 2022 (from $12,745 to $26,067)
• The establishment registration fee doubled from FY 2022 to FY 2026 ($5,672 to $11,423)
• PMA fees increased 58% over four years
• These trends are expected to continue under MDUFA V reauthorization

Frequently Asked Questions

Do I need to pay the establishment registration fee if I haven't started selling devices yet?

No. If you are not yet distributing any devices in the US, you are not required to register your establishment, and registration is not required before submitting a new device submission.

Can I get a refund if my 510(k) is withdrawn?

Yes, in certain circumstances. The FDA may issue a refund if the submission is withdrawn before the FDA begins its review. However, once the review has commenced, the fee is non-refundable.

Does the small business fee apply to the establishment registration?

No. The establishment registration fee is the same ($11,423) for all establishments regardless of business size. The new FY 2026 waiver program is the only potential relief, and it has strict eligibility requirements.

What if my company is based outside the US?

Foreign companies must still pay the same user fees as domestic companies. For small business determination, you must provide documentation of your gross receipts/sales through the CDRH Portal — foreign tax returns or financial statements may be accepted.

When will FY 2027 fees be announced?

The FDA typically announces user fees for the next fiscal year in a Federal Register notice published in July or August preceding the fiscal year. FY 2027 fees are expected to be announced in July/August 2026.

Can I pay user fees by credit card?

Yes, but allow extra processing time. The FDA warns that credit card payments may take several business days to clear. Your submission will be placed on "User Fee Hold" until the payment is confirmed.

Key Takeaways

• 510(k) fees are $26,067 (standard) / $6,517 (small business) — a 7.1% increase from FY 2025
• The establishment registration fee jumped 23% to $11,423 — the largest single-year increase in recent memory
• Small businesses (≤$100M revenue) save 75% on submission fees — apply via CDRH Portal by August 1
• First-time PMA filers (≤$30M revenue) can waive the entire $579,272 fee — use this strategically
• A new registration fee waiver is available for micro-businesses (≤$1M) — but it's discretionary and requires proof of financial hardship
• Plan your submission timing around the October 1 fiscal year boundary to optimize fee payments
• User fees have doubled in the last 4 years — build annual increases into your multi-year regulatory budget