FY2027 Medical Device User Fees: What Manufacturers Need to Know
- Nexgen Health Group
- Jul 30
- 4 min read
Updated: 7 days ago
The FDA has published its Medical Device User Fee Amendments, or MDUFA, fee schedule for Fiscal Year 2027.
The new fees will apply from October 1, 2026, through September 30, 2027. Medical device manufacturers planning submissions during this period should update their regulatory budgets and submission timelines accordingly.
FY2027 Annual Establishment Registration Fee
The Annual Establishment Registration Fee for FY2027 is:
$13,785
Most medical device establishments required to register with the FDA must pay this annual fee.
Unlike application fees, the establishment registration fee generally does not have a standard reduced small-business rate. However, for FY2027, the FDA may grant a waiver of the annual fee, excluding the initial registration fee, to certain businesses that:
Qualify through the Small Business Determination Program; and
Demonstrate that payment would represent financial hardship, as determined by the FDA.
The waiver is therefore limited and should not be treated as an automatic small-business discount.
FY2027 Medical Device Application Fees
Application type | Standard fee | Small-business fee |
510(k) | $28,653 | $7,163 |
513(g) Request for Information | $8,596 | $4,298 |
PMA, PDP, PMR, or BLA | $636,732 | $159,183 |
De Novo Classification Request | $191,020 | $47,755 |
Panel-Track Supplement | $509,386 | $127,347 |
180-Day Supplement | $95,510 | $23,878 |
Real-Time Supplement | $44,571 | $11,143 |
BLA Efficacy Supplement | $636,732 | $159,183 |
30-Day Notice | $10,188 | $5,094 |
Annual Periodic Reporting Fee for a Class III Device | $22,286 | $5,572 |
The reduced rates are available only to businesses that have been qualified by the FDA’s Center for Devices and Radiological Health as small businesses.
How Much Are the Fees Increasing?
Compared with FY2026, several major application fees are increasing by approximately 10%.
For example:
The standard 510(k) fee increases from $26,067 to $28,653.
The De Novo fee increases from $173,782 to $191,020.
The PMA fee increases from $579,272 to $636,732.
The Annual Establishment Registration Fee increases from $11,423 to $13,785.
The establishment registration fee is increasing more significantly than the major application fees. This increase may affect not only companies preparing new submissions but also establishments that must maintain their FDA registration each year.
Why the Submission Date Matters
FDA user fees are tied to the fiscal year in which the FDA receives the submission.
Therefore:
A submission received on or before September 30, 2026, is generally subject to the FY2026 fee.
A submission received on or after October 1, 2026, is subject to the FY2027 fee.
Companies preparing a submission near the end of the fiscal year should carefully coordinate the submission date, user fee payment, MDUFA cover sheet, and final technical documentation.
A submission should not be rushed solely to avoid a fee increase. An incomplete or poorly prepared submission may create far greater costs through Refuse to Accept issues, additional information requests, testing deficiencies, or delays in FDA review.
Small Business Determination Can Create Significant Savings
Eligible companies may qualify for substantially reduced application fees through the FDA’s Small Business Determination Program.
For example, the FY2027 510(k) fee is reduced from $28,653 to $7,163 for a qualified small business.
The De Novo fee is reduced from $191,020 to $47,755, while the PMA fee is reduced from $636,732 to $159,183.
However, Small Business status is not granted automatically based on company size. A company must apply for and receive FDA qualification before relying on the reduced fee.
Foreign businesses may also need to obtain and submit supporting tax documentation from the relevant national taxing authority. Companies should therefore begin the Small Business Determination process well before their planned FDA submission.
Special Rule for Third-Party 510(k) Reviews
Traditional, Abbreviated, and Special 510(k) submissions are generally subject to the FDA user fee.
However, the FDA states that there is no user fee for a 510(k) submitted to the agency on behalf of an FDA-accredited third-party review organization.
This does not necessarily mean that the overall review process is free. The accredited review organization may charge its own review fees, and not every device is eligible for the Third Party Review Program.
Manufacturers should first confirm whether their device and product code qualify for third-party review.
User Fees Are Only One Part of the Regulatory Budget
The FDA user fee is only one component of the total cost of entering the U.S. medical device market.
Depending on the device and submission pathway, manufacturers may also need to budget for:
Product classification and regulatory strategy
Performance and bench testing
Electrical safety and electromagnetic compatibility testing
Biocompatibility testing
Software and cybersecurity documentation
Sterilization validation
Shelf-life and packaging validation
Clinical evidence
Quality system implementation
Labeling and Unique Device Identification compliance
FDA establishment registration and device listing
U.S. Agent and Initial Importer arrangements, when applicable
Building a realistic regulatory budget early can help companies avoid unexpected costs and delays.
Key Takeaway
The FY2027 FDA medical device fees will apply beginning October 1, 2026.
Companies planning a 510(k), De Novo, PMA, or other medical device submission during FY2027 should:
Confirm the appropriate regulatory pathway.
Update the project budget using the FY2027 fee schedule.
Determine whether the company may qualify for Small Business status.
Begin the qualification process well before submission.
Coordinate the planned submission date with testing and documentation readiness.
FDA fees should be considered early in the market-entry strategy—not immediately before the submission is filed.
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