Medical Device User Fee Amendments (MDUFA)
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Minutes from industry discussions on MDUFA V reauthorization are available:
User Fees for FY2021
Annual Establishment Registration Fee: $5,546
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 2021 (October 1, 2020 through September 30, 2021) are:
| Application Type | Standard Fee | Small Business Fee† |
|---|---|---|
| 510(k)‡ | $12,432 | $3,108 |
| 513(g) | $4,936 | $2,468 |
| PMA, PDP, PMR, BLA | $365,657 | $91,414 |
| De Novo Classification Request | $109,697 | $27,424 |
| Panel-track Supplement | $274,243 | $68,561 |
| 180-Day Supplement | $54,849 | $13,712 |
| Real-Time Supplement | $25,596 | $6,399 |
| BLA Efficacy Supplement | $365,657 | $91,414 |
| 30-Day Notice | $5,851 | $2,926 |
| Annual Fee for Periodic Reporting on a Class III device (PMAs, PDPs, and PMRs) | $12,798 | $3,200 |
† Small Business Fee: For small businesses with an approved Small Business Determination (SBD).
‡ 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.
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 PMA, PDP, PMR, or BLA.
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.
Guidance: Medical Device User Fee Small Business Qualification and Certification