The FDA or U.S. Food and Drug Administration recently announced the Fiscal Year Medical Device User Fee (MDUFA) amendments.
The fiscal year will begin on October 1st, 2022, and end on September 30th, 2023. All medical device facilities will have to pay these fees to remain FDA-compliant.
In this blog, we’re going to elaborate on everything that you should know going into 2023 and which we’ll elaborate on everything you should know including which fees may apply in 2023.
Medical Devices and Establishments:
- Certain medical device applications
- Periodic reporting on class III devices
- Annual registration of establishments
All businesses that have sales that are less than $100 million in the most recent tax year can qualify as small businesses and pay a reduced fee on their applications. If your business has sales of less than $30 million you can receive a waiver for your first premarket application or reports.
These Medical Device Establishment registration fees are consistent no matter the business size and must be paid to complete registrations. There are no waivers or reductions for small businesses, establishments, or groups when it comes to this establishment registration fee. This fee must be paid for every physical location a company owns that handles applicable medical device functions. All medical device fees have increased to deal with inflation over the last year as a result of FDA suggestions.
What is the purpose of Medical Device User Fees:
- User fees are used to fund FDA’s medical device regulatory programs
- MDUFA fees are used to fund the medical device user fee program
- FDA uses these fees to review new medical devices and monitor the safety of existing devices
- FDA has a budget for these fees
FDA’s Medical Device User Fee Programs:
- MDUFA VI is the sixth amendment to the Medical Device User Fee and Modernization Act (MDUFMA)
- MDUFA VI was signed into law in December 2017
- MDUFA VI will go into effect on October 1, 2022
FDA’s Proposed FY 2023 Medical Device User Fee Rates:
- increase in fees for the first time since 2017
- MDUFA VI rates are based on the number of submissions and inspections
- MDUFA VI rates are based on inflation and volume
- MDUFA VI rates are lower than the proposed FY 2023 MDUFA VI rates
FY 2023 MDUFMA Financial Highlights:
- FDA is proposing to refund 50% of the user fee for 510(k) applications filed in 2023
- FDA is proposing to refund 50% of the user fee for Premarket Reports filed in 2023
FDA’s Proposed FY 2023 Refund Policy for the Premarket Application User Fee and the Premarket Report User Fee:
- FDA is proposing to refund 50% of the user fee for 510(k) applications filed in 2023
- FDA is proposing to refund 50% of the user fee for Premarket Reports filed in 2023
How Quality Smart Solutions can help
FDA won’t consider medical device registrations to be complete until all required payments have been paid and the deadline for renewal is December 31st, 2022. If not paid, the FDA can remove your registration from its database.
Our experts at Quality Smart Solutions are here to help and offer medical device-related regulatory advice and support on successfully securing your medical device licenses and registrations. We can help you by responding to potential information requests, keeping your licenses and registrations updated, and reviewing your device labels.
Contact us today to learn more about how we can support your compliance needs during and after licensing! For more assistance with FDA regulatory requirements call 1-800-396-5144, email: info@qualitysmartsolutions.com, or book a FREE regulatory consultation with one of our experts using the form.
How can Quality Smart Solutions help you ensure your 510k medical devices are FDA-compliant? We offer medical device license application services that consist of preparing and submitting applications, as well as handling communication with the FDA. Our team of experts can handle all medical licensing matters and are happy to help you with future projects or questions! Please find our contact information here:
