Medical Device User Fee Amendments (MDUFA)
User Fees for FY2023
Annual Establishment Registration Fee: $6,493
All establishments must pay the establishment registration fee. There are no waivers or reductions for small establishments, businesses, or groups.
Other fees for Fiscal Year 2023 (October 1, 2022 through September 30, 2023) are:
|Application Type||Standard Fee||Small Business Fee†|
|PMA, PDP, PMR, BLA||$441,547||$110,387|
|De Novo Classification Request||$132,464||$33,116|
|BLA Efficacy Supplement||$441,547||$110,387|
|Annual Fee for Periodic Reporting on a Class III device (PMAs,PDPs, and PMRs)||$15,454||$3,864|
† 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.
Device user fees were first established in 2002 by the Medical Device User Fee and Modernization Act (MDUFMA). User fees were renewed in:
- 2007, with the Medical Device User Fee Amendments (MDUFA II) to the FDA Amendments Act (FDAAA)
- 2012, with the Medical Device User Fee Amendments (MDUFA III) to the FDA Safety and Innovation Act (FDASIA)
- 2017, with the Medical Device User Fee Amendments (MDUFA IV) to the FDA Reauthorization Act (FDARA). MDUFA IV will be in place from Oct. 1, 2017 until Sept. 30, 2022.
- 2022, with the Medical Device User Fee Amendments (MDUFA V) to the Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023. MDUFA V will be in place from Oct. 1, 2022 until Sept. 30, 2027.
Under the user fee system, medical device companies pay fees to the FDA when they register their establishments and list their devices with the agency, whenever they submit an application or a notification to market a new medical device in the U.S. and for certain other types of submissions. These fees help the FDA increase the efficiency of regulatory processes with a goal of reducing the time it takes to bring safe and effective medical devices to the U.S. market.
Waivers: Small businesses with an approved Small Business Determination (SBD) with gross receipts or sales of $30 million or less are eligible to have the fee waived on their first Premarket Approval Application (PMA), Product Development Protocol (PDP), Premarket Report (PMR), or Biologics License Application (BLA).
Reduced Fees: Small businesses with an approved Small Business Determination (SBD) with gross receipts or sales of $100 million or less are eligible for a reduced fee on: 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.
Submitting a Small Business Certification Request: CDRH's Small Business Program determines whether a business is qualified and certified as a "small business" and eligible for a reduced fee for some types of CDRH submissions that require a user fee. For details on submitting a certification request, see Reduced Medical Device User Fees: Small Business Determination (SBD) Program.
- FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals
- FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals
- FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals
- User Fees and Refunds for De Novo Classification Requests
- User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications
- User Fees and Refunds for Premarket Notification Submissions (510(k)s)
- User Fees and Refunds for 513(g) Requests for Information
- Medical Device User Fee Small Business Qualification and Certification: Guidance for Industry, Food and Drug Administration Staff and Foreign Governments
For other guidance documents, see MDUFA Guidance Documents.