FY2022 User Fees

FY2022 User Fees

The US FDA released the 2022 user fees for certain medical device submissions and establishment registration. On August 2, 2021, the FDA announced the FY2022 user fees in a Federal Register notice titled Medical Device User Fee Rates for Fiscal Year 2022. FY2022 User fees are required for the following types of medical device submissions:

FY2022 User Fees

Standard fee

Small business fee

Premarket application (a PMA, PDP, or BLA) $ 374,858 $ 93,714
Premarket report $ 374,858 $ 93,714
Efficacy supplement (to an approved BLA) $ 374,858 $ 93,714
Panel-track supplement $ 281,143 $ 70,286
De novo classification request $ 112,457 $ 28,114
180-day supplement $ 56,229 $ 14,057
Real-time supplement $ 26,240 $ 6,560
510(k) premarket notification submission $ 12,745 $ 3,186
30-day notice $ 5,998 $ 2,999
513(g) request for classification information $5,061 $ 2,530
Annual Fees:
Annual fee for periodic reporting on a class III device $ 13,120 $ 3,280
Annual establishment registration fee $ 5,672 $ 5,672

SoftwareCPR® can assist with US FDA regulatory strategy, planning, and interaction.  Would you like to discuss FY2022 User Fees more?  Contact us!

Want to understand FY2022 user fees more?  See our post Breakdown of FDA’s Medical Device User Fees

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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