FDA announced the updated medical device user fees for the fiscal year 2019/2020, which apply from October 1, 2019, through September 30, 2020. 

USA: FDA medical device user fees FY 2020

Establishment Registration Fee

For the FY 2020, the amount for each establishment registration is set at $5,236 after adjustment. This fee shall be paid between October 1 and December 31, 2019. There is no small business rate for the annual establishment registration fee; all establishments pay the same fee.

FY2020 user fees for applications

Application Type Standard Fee 2019 Small Business Fee 2019
510(k) $11,594 $2,899
513(g) $4,603 $2,302
De Novo classification $102,299 $25,575
PMA, PDP, PMR, BLA $340,995 $85,249
Panel-track supplement $255,747 $63,937
180-day supplement $51,149 $12,787
Real-time supplement $23,870 $5,968
BLA efficacy supplement $340,995 $85,249
Annual Report $11,935 $2,984
30-day notice $5,456  $2,728

The updated amounts refer to all applications submitted to the FDA after October 1, 2019.