Services to Ease FDA Regulatory Compliance

FY 2020 Medical Device Registration Fee

8

Aug

2019

FDA has published  Medical Device Registration Fee for  FY 2020 .FDA  Medical  device  registration fee

Medical Device establishment registration fee  for FY 2020 is    $5,236 , no waiver or fee reduction for small companies. Medical device registration fee FY 2020  will be effective from 1st October , 2019. 

In order to renew  registration   for FY2020 , medical device establishment  renewal fee $  5236 is applicable.  Facilities which  are registered in FY 2019  must renew the medical device registration and listing before 31st December  2019.  The renewal period for FY 2020 begins on 1st October 2019. 

In order pay medical device registration fee, applicant  must generate the user fee cover sheet.  Here are the step by step instructions for FDA fee payment. 

  1. Create user fee account 
  2. Prepare the use cover sheet for FY 2020 registration 
  3. After submitting  the cover sheet, you can make online  payment 

 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. 
 
 
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