FDA Published User Fees for FY 2019

 

  • 510(k), Standard: $10,953
    • (in FY 2018: $10,566) 
  • 510(k), small business:  $2,738
    • (in FY 2018: $2,642)
  • De Novo classification, Standard: $96,644
    • (in FY 2018: $93,229)
  • De Novo classification, small business $24,161
    • (in FY 2018: $23,307)
  • PMA, Standard: $322,147
    • (in FY 2018: $310,764)
  • PMA, Small Business: $80,537
    • (in FY 2018: $77,691)

The full overview for FY 2019 as published on the FDA Website (for FY 2018)