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FY 2020 FDA fee for Medical Device

8

Aug

2019

FY 2020  FDA fee for Medical Device is now published, here is the summary of  MDUFA Fee for FY 2020.

Medical Device establishment registration fee  for FY 2020 is    $5,236 , no waiver or fee reduction for small companies. 

Other medical device submission fee for FY 2020

  • 510(k)‡ – Standard Fee 11,594. Small Business Fee 2,899.
  • 513(g) – Standard Fee 4,603. Small Business Fee 2,302.
  • PMA, PDP, PMR, BLA – Standard Fee 340,995. Small Business Fee 85,249.
  • De Novo Classification Request – Standard Fee 102,299. Small Business Fee 25,575.
  • Panel-track Supplement – Standard Fee 255,747. Small Business Fee 63,937.
  • 180-Day Supplement – Standard Fee 51,149. Small Business Fee 12,787.
  • Real-Time Supplement – Standard Fee 23,870. Small Business Fee 5,968.
  • BLA Efficacy Supplement – Standard Fee 340,995. Small Business Fee 85,249.
  • 30-Day Notice – Standard Fee 5,456. Small Business Fee 2,728.
  • Annual Fee for Periodic Reporting on a Class III device (PMAs, PDPs, and PMRs) – Standard Fee 11,935. Small Business Fee 2,984.
† For small businesses with an approved SBD.
‡ Note: All types of 510(k)s (Traditional, Abbreviated, and Special) are subject to the user fee. However, there is no user fee for 510(k)s submitted by an FDA-accredited Third-Party Reviewer to the FDA.
 
The FY2020 user fees apply to medical device submissions received by the FDA on or after October 1, 2019. If you wish to pay the FY2019 user fee for a submission, both your submission and your user fee payment 

 

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