On July 28, 2023, the Food and Drug Administration (FDA) announced the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2024.[1] The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Medical Device User Fee Amendments of 2022 (MDUFA V), authorizes the FDA to collect medical device user fees for certain device submissions and annual fees, both for certain periodic reports and for establishments subject to registration. This notice establishes the fee rates for FY 2024, which apply from October 1, 2023, through September 30, 2024—and provides information on how the medical device user fee rates for fiscal year 2024 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.
Medical device firms are required to pay fees to the FDA under the user fee system when they register their businesses and list their products with the agency, when they apply or notification [SY1] to sell a new medical device in the United States, and for a few other types of submissions. With the aim of speeding up the process of bringing safe and effective medical devices to the U.S. market, these fees assist the FDA in improving the effectiveness of regulatory procedures.
All establishments must pay an FDA annual registration fee; there are no waivers or reductions for small establishments, businesses, or groups in the FY 2024. However, the FDA registration fee for the first Premarket Approval Application (PMA), Product Development Protocol (PDP), Premarket Report (PMR), or Biologics License Application (BLA) is waived for small businesses with an approved Small Business Determination (SBD) whose gross receipts or sales are $30 million or less. And small businesses with approved Small Business Determination (SBD) and gross receipts or sales of $100 million or less may be eligible for reduced medical device user fees for Premarket Notification (510(k)), De Novo request, Premarket Applications (Premarket Approval Application (PMA)), Biologics License Application (BLA), Product Development Protocol (PDP), Premarket Report (PMR), PMA/BLA Supplements and PMA Annual Reports, and 513(g) request for classification information.
The FDA User Fees for 2024 vs. 2023 at a Glance
The difference between FDA medical device user fees from 2023 and 2024 are summarized in the table below:
| Application Type | MDUFA Fees FY 2023 | MDUFA Fees FY 2024 | ||
| Standard Fee | Small Business Fee† | Standard Fee | Small Business Fee† | |
| 510(k)‡ | $19,870 | $4,967 | $21,760 | $5,440 |
| 513(g) | $5,961 | $2,980 | $6,528 | $3,264 |
| PMA, PDP, PMR, BLA | $441,547 | $110,387 | $483,560 | $120,890 |
| De Novo Classification Request | $132,464 | $33,116 | $145,068 | $36,267 |
| Panel-track Supplement | $353,238 | $88,309 | $386,848 | $96,712 |
| 180-Day Supplement | $66,232 | $16,558 | $72,534 | $18,134 |
| Real-Time Supplement | $30,908 | $7,727 | $33,849 | $8,462 |
| BLA Efficacy Supplement | $441,547 | $110,387 | $483,560 | $120,890 |
| 30-Day Notice | $7,065 | $3,532 | $7,737 | $3,869 |
| Annual Fee for Periodic Reporting on a Class III device (PMAs, PDPs, and PMRs) | $15,454 | $3,864 | $16,925 | $4,231 |
For more information about the MDUFA decision, the new MDUFA user fees for 2024, or to learn more about how to get FDA approval for your medical device, contact us here.
[1] Federal Register :: Medical Device User Fee Rates for Fiscal Year 2024
