US: FDA publishes user fee amounts for medical device manufacturers in 2021
The FDA has recently published the user fee amounts which will be collected from medical device manufacturers in fiscal year 2021. Meditrial is the partner for medical device manufacturers in the US. Reach out to Meditrial for clinical or regulatory assistance!
The amounts are listed in the table below:
| Medical Device User Fee Amendments (MDUFA IV) | FY2021 (small business fee) | FY2020 (small business fee) | Change |
| Premarket application (a PMA submitted under section 515(c)(1) of the FD&C Act (21 U.S.C. 360e(c)(1)), a PDP submitted under section 515(f) of the FD&C Act (21 U.S.C. 360e(f), or a BLA submitted under section 351 of the Public Health Service Act (the PHS Act) (42 U.S.C. 262)) | $365,657 ($91,414) | $340,995 ($85,249) | $24,662 ($6,165) |
| Premarket report (submitted under section 515(c)(2) of the FD&C Act) | $365,657 ($91,414) | $340,995 ($85,249) | $24,662 ($6,165) |
| Efficacy supplement (to an approved BLA under section 351 of the PHS Act) | $365,657 ($91,414) | $340,995 ($85,249) | $24,662 ($6,165) |
| Panel-track supplement | $274,243 ($68,561) | $255,747 ($63,937) | $18,496 ($4,624) |
| De novo classification request | $109,697 ($27,424) | $102,299 ($25,575) | $7,398 ($1,849) |
| 180-day supplement | $54,849 ($13,712) | $51,149 ($12,787) | $3,700 ($925) |
| Real-time supplement | $25,596 ($6,399) | $23,870 ($5,968) | $1,726 ($431) |
| 510(k) premarket notification submission | $12,432 ($3,108) | $11,594 ($2,899) | $838 ($209) |
| 30-day notice | $5,851 ($2,926) | $5,456 ($2,728) | $395 ($198) |
| 513(g) request for classification information | $4,936 ($2,468) | $4,603 ($2,302) | $333 ($166) |
| Annual fee type: | |||
| Annual fee for periodic reporting on a Class III device | $12,798 ($3,200) | $11,935 ($2,984) | $863 ($216) |
| Annual establishment registration fee | $5,546 ($5,546) | $5,236 ($5,236) | $310 ($310) |
For more details, please see the official document from the FDA.
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- Identify patients requiring follow-up
- Conduct investigator and study nurse calls for training to address the situation
- Obtain authorizations for decentralized data collection
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- Prepare procedures and worksheets for remote collection of patient clinical data
- Monitor work instructions and trainings for site support and remote monitoring
- EDC and ePRO solutions to enable study continuity
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This article provides general information and does not constitute regulatory or legal advice. Requirements should be confirmed for the specific study, applicable regulatory framework, and markets concerned.
