US: FDA publishes user fee amounts for medical device manufacturers in 2021

2020-08-03T09:20:17+00:00August 3rd, 2020|Categories: Clinical Trial, Software, USA|1 Comment

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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One Comment

  1. Amalia7619-borrow February 13, 2021 at 3:40 pm

    Great post – no words. Thank.

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