US FDA Medical Device User Fee For FY2020 (Effective Oct 2020)

US FDA Medical Device User Fee For FY2020 (Effective Oct 2020)

Application Fee Type Standard Fee (as a percent of the standard fee for a premarket application) FY 2021 Standard Fee FY 2021 Small Business Fee
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, or a BLA submitted under section 351 of the Public Health Service Act (the PHS Act) (42 U.S.C. 262)) Base fee specified in statute $365,657 $91,414
Premarket report (submitted under section 515(c)(2) of the FD&C Act) 100 $365,657 $91,414
Efficacy supplement (to an approved BLA under section 351 of the PHS Act) 100 $365,657 $91,414
Panel-track supplement 75 $274,243 $68,561
De novo classification request 30 $109,697 $27,424
180-day supplement 15 $54,849 $13,712
Real-time supplement 7 $25,596 $6,399
510(k) premarket notification submission 3.40 $12,432 $3,108
30-day notice 1.60 $5,851 $2,926
513(g) request for classification information 1.35 $4,936 $2,468
Annual Fee Type      
Annual fee for periodic reporting on a class III device 3.50 $12,798 $3,200
Annual establishment registration fee (to be paid by the establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device, as defined by 21 U.S.C. 379i(14)) Base fee specified in statute $5,546 $5,546

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