FDA: 2023 Medical Device User Fees Announcement

Medical device user fees for the Fiscal Year 2023 are now available following an announcement from the U.S. Food and Drug Administration (FDA). The fiscal year runs from October 1, 2022 – September 30, 2023. All medical device facilities must pay the new fee amounts to keep their FDA status.

Understanding Medical Device User Fees

Medical device companies must pay fees to the FDA for:

• Annual registrations
• Reporting of class III devices
• Certain device applications

Reduced fee applications are available for businesses that must pay user fees but have sales totaling less than $100 million in their most recent tax year. First premarket applications can have their fees waived if sales are less than $30 million.

Businesses that received a fee waiver in 2022 will need to resubmit their documentation to renew their waivers.

The annual establishment registration must be paid for all registrations. Fees for this registration are the same for all businesses, no matter the size or annual revenue. The annual establishment registration must be submitted and paid for by each company-owned physical location that handles specific functions for medical devices.

FDA officials state that the increase in fees, which have been seen across all medical device fees, is to account for the rise in inflation within the past year.

The annual establishment registration fee has risen from $5,546 in 2022 to $6,493. However, the following fees will be determined by the size of the business:

• 501(k)
• 513(g)
• 180-day supplement
• BLA efficacy supplements
• De Novo Classification
• Panel-track supplement
• PMA, PDP, PMR, BLA
• PMA annual report
• Real-time supplement

Completing Medical Device Registrations

Medical device user fees must be paid for any device registration to be considered “complete.” Payments must be made by December 31. If you have not remitted payment by the due date, your establishment may be removed from the FDA database. Removal from the database will mean that your registration is invalid.