FDA Announces Fiscal Year 2027 Medical Device User Fees

FDA user fees are updated every fiscal year under statutory formulas that account for program revenue requirements and economic trends such as inflation. FDA recently released its user fees for the next fiscal year, which begins October 1, 2026. This annual update adjusts the fees charged for medical device submissions under MDUFA V. More substantial changes to the MDUFA program are expected beginning in fiscal year 2028 through MDUFA VI, the proposed five-year reauthorization covering fiscal years 2028 through 2032.

MDUFA fees are important as they support FDA reviewer staffing, training, public outreach, and programs such as the Center for Devices and Radiological Health’s (CDRH) Experiential Learning Program (ELP) and Total Product Life Cycle Advisory Program (TAP). They also help maintain predictable review timelines and FDA review capacity, supporting efficient device reviews and helping companies bring innovative medical devices to market. Although FDA has recently faced challenges meeting some review timelines, MDUFA’s performance goals and accountability mechanisms provide industry with greater predictability than it would have in their absence.

How Much Will These Changes Cost?

Reflecting inflation, including increased payroll and non-payroll costs, and other statutory adjustments, FDA increased most medical device submission fees by approximately 9.9%, while the annual establishment registration fee increased by 20.7%. Medical device companies planning multiple PMAs or 510(k)s may see substantial increases in their aggregate user-fee costs.

*FDA’s small-business designation does not automatically reduce the annual establishment registration fee. Certain designated small businesses may separately apply for a financial-hardship waiver of the annual fee, excluding an establishment’s initial registration.

Careful submission timing and small-business qualification can save companies thousands of dollars. For example, a standard PMA received by FDA by September 30, 2026, after the applicable fee has been paid and processed, would cost $57,460 less than the same PMA received on or after October 1, 2026. A small business designation, which is based on gross sales (equal to or less than $100M, including affiliates) and granted via a submission, can save thousands, reducing a 510(k) submission fee in FY27 from $28,653 to $7,163. Because the applicable fee is determined by FDA’s submission receipt date, paying a fee in advance does not preserve the prior fiscal year’s rate for a submission received in the following fiscal year. 

Medical device companies need to be aware of MDUFA, both yearly changes to fees and the larger updates that occur every five years. This allows for improved resource planning and the opportunity to be heard on what improvements should be added in future iterations.

Nathan Downing, Managing Attorney

Contact Gardner Law 

User fees are one of the many considerations companies must account for when bringing a medical device to market. Because these fees can consume a sizable portion of a regulatory budget, companies should incorporate them accurately into their submission planning. Gardner Law advises medical device companies on all aspects of regulatory strategy, including submission timing and budgeting considerations. Contact us to discuss a regulatory assessment and develop an appropriate path forward.