On July 28, 2023, the U.S. Food and Drug Administration (FDA) announced the Medical Device User Fee for Fiscal Year 2024 (FY 2024). This fee will be applicable from October 1, 2023, to September 30, 2024.
All companies involved in the manufacturing and distribution of medical devices for sale in the U.S. market are required to pay an annual establishment registration fee to the FDA.
Companies that need to complete or renew new registrations should be mindful of the deadlines and associated costs.
What is Medical Device User Fee?
The Medical Device User Fee is a fee authorized by the Medical Device User Fee Amendments of 2022 (MDUFA V) to the Federal Food, Drug, and Cosmetic Act (FD&C Act). It grants the FDA the authority to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. Section 738 of the FD&C Act (21 U.S.C. 379j) establishes fees for certain medical device applications, submissions, supplements, notices, and requests (for simplicity, this document refers to these collectively as “submissions” or “applications”); for periodic reporting on class III devices; and for the registration of certain establishments.
FDA user fees crucially support FDA's public health activities and provide funding to secure the necessary staff to conduct product review processes.
FY 2024 Medical Device User Fees
Annual Establishment Registration Fee: $7,653
There are no waivers or reductions for the annual registration fee for small businesses, firms, or groups.
Other review fees are as follows:
When is the deadline for FY 2024 Medical Device Annual Establishment Registration?
The FY 2024 annual establishment registration user fee can be paid anytime between October 1 and December 31. There is no penalty for paying late, but if the fee is not paid, the registration status will become inactive, and you will not be able to submit new device applications or import products to the USA.
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