UPDATE:
Breaking News: The Medical Device User Fees have just been announced for FY2023. The Annual Establishment Registration Fee is $6,493. Other fees are now listed and can be found here: https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa?utm_medium=email&utm_source=govdelivery
Original Post:
Medical device companies with a history in the U.S. market will be familiar with the requirement to pay a user fee to the Food and Drug Administration (FDA) prior to registering their facility. Although the registration renewal season officially began on October 1, companies looking to complete their annual medical device facility registration for 2023 have so far been unable to do so. FDA has been unable to announce the fees for 2023 due to a delay in the required authorization from Congress. The fee portal is currently not accepting fees, offering the following message:
FDA is awaiting congressional action to provide authority to collect FY 2023 user fees under the Biosimilar User Fee Act (BsUFA), Generic Drug User Fee Amendments (GDUFA), Medical Device User Fee Amendments (MDUFA) and Prescription Drug User Fee Act (PDUFA) programs. As a result, FDA cannot accept FY23 coversheets for these user fee programs at this time. FDA will announce the FY 2023 user fee rates and payment instructions through Federal Register notices once legislation authorizing FDA to collect user fees for FY 2023 is signed into law.
While inconvenient for companies who prefer to fulfill their registration requirement as early as possible, existing registrations will maintain validity through the end of the year. However, this delay is problematic for first-time medical device establishment registrants who need to register in order to begin operations in the U.S. market. FDA’s Center for Devices and Radiological Health (CDRH) has advised that companies must wait to register their facilities until the new user fees are announced.
Other user fee-bound industries have been impacted as well, such as generic and prescription drug companies looking to pay the fees required under the Generic Drug User Fee Amendments (GDUFA) and Prescription Drug User Fee Act (PDUFA).
CDRH has informed our firm that Congress has reauthorized the collection of user fees in recent days, and that they expect an announcement from FDA on the 2023 user fee amounts by the end of this week. When the fee amounts are determined, FDA will publish a Federal Register notice and further update the Device Facility User Fee website.
FDAImports will continue to monitor the situation, and we plan to share the announced fees in an update to this page as soon as they become available. Please check back for updates. If you require assistance with the registration of your facility, please don’t hesitate to contact our experts here.
This blog/post is provided for informational and educational purposes only and does not constitute legal advice, and is not intended to form an attorney-client relationship. Please contact your regular Benjamin L. England & Associates, LLC attorney contact for additional information.
