Medical Device User Fee Amendments (MDUFA): Fees | FDA
October 1, 2025, through September 30, 2026. Most establishments must pay the establishment registration fee. For more information, see Who Must Register, List and Pay the Fee and When to...
Medical Device User Fee Rates for Fiscal Year 2025 - Federal Register
Jul 31, 2024 · The FD&C Act specifies the base fee for establishment registration for each year from FY 2023 through FY 2027; the base fee for an establishment registration in FY 2025 is $7,100.
Medical Device User Fees for Fiscal Year 2025 - U.S. Food and Drug ...
On July 31, 2024, the U.S. Food and Drug Administration (FDA) issued a Federal Register notice announcing medical device user fees and annual establishment registration fees for Fiscal Year …
Medical Device FDA Registration Fees 2025 - fdahelp.us
FDA Medical Device Establishment registration fee for the year 2025 is USD 9,280. FDA fiscal year 2025 starts on October 1, 2024, and ends on September 30, 2025.
FDA Fees Summary for 2025: What You Need to Know
Oct 29, 2024 · Stay updated with the FDA fees for 2025. Get a detailed summary of costs, changes, and what businesses need to know for compliance and budgeting.
FDA Medical Device Registration Fee and waiver guide
Jul 31, 2025 · The FDA medical device registration fee for FY 2026 is set at $11,423, a 23% increase from FY 2025. This fee applies to all medical device companies registering with the U.S. Food and …
FY2025 Medical Device User Fee Amendments (MDUFA) Has Been …
Aug 5, 2024 · For this period, the annual establishment registration fee is set at $9,280. This fee is mandatory for all new medical device establishments registering with the FDA in FY2025, as well as …
The FDA Has Just Announced Their User Fees for FY 2025
All establishments must pay the establishment registration fee. There are no waivers or reductions for small establishments, businesses, or groups in FY 2025. The FDA just announced the annual …
Understanding Device User Fees for Medical Devices in FY 2025 ...
Aug 6, 2024 · FY 2025 Fee: $9,280. All medical device establishments must pay this annual fee to register their facilities with the FDA. This fee has increased from $7,653 in FY 2024, reflecting the …
Jul 31, 2024 · Annual Establishment Registration Fee Waiver For FY 2025, there is no small business waiver for the annual establishment registration fee; all establishments pay the same fee.