FDA recently announced the updated medical device fees for the 2024 fiscal year (October 1, 2023 – September 30, 2024).
All medical device manufacturers, importers, and distributors must pay an annual establishment registration fee to FDA. Please do not wait until the last minute to pay these fees! The Device Facility User Fee (DFUF) is $7,653 this year and must be paid between October 1, 2023, and December 31, 2023. It is also important to note that FDA will not grant waivers or reductions for small establishments, businesses, or groups in FY 2024. For more information about FDA’s annual registration requirement, read our recent blog.
Additionally, FDA collects user fees for certain medical device submissions. The below table are other FY2024 User Fees for Medical Device Submissions:
Additionally, FDA collects user fees for certain medical device submissions. The below table are other FY2024 User Fees for Medical Device Submissions:
| Application Type | Standard Fee | Small Business Fee† |
| 510(k)‡ | $21,760 | $5,440 |
| 513(g) | $6,528 | $3,264 |
| PMA, PDP, PMR, BLA | $483,560 | $120,890 |
| De Novo Classification Request | $145,068 | $36,267 |
| Panel-track Supplement | $386,848 | $96,712 |
| 180-Day Supplement | $72,534 | $18,134 |
| Real-Time Supplement | $33,849 | $8,462 |
| BLA Efficacy Supplement | $483,560 | $120,890 |
| 30-Day Notice | $7,737 | $3,869 |
| Annual Fee for Periodic Reporting on a Class III device (PMAs,PDPs, and PMRs) | $16,925 | $4,231 |
† Small Business Fee: For businesses certified by the Center for Devices and Radiological Health (CDRH) as a small business.
‡ 510(k) Fees: All types of 510(k)s (Traditional, Abbreviated, and Special) are subject to the user fee. However, there is no user fee for 510(k)s submitted to the FDA on behalf of an FDA-accredited third-party reviewer.
Manufacturers, importers, and distributors failing to pay the relevant fees risk being detained at the border. Don’t let that happen to you. FDAImports can help you navigate this process and ensure you are registered correctly and on time.
FDAImports can also ensure that all FDA requirements are satisfied, including 510(k) preparation and submission, medical device labeling, medical device quality system requirements, and complaint handling systems. FDA is adding more and more foreign medical device companies to Import Alerts 89-09 and 80-04. Contact us today.
