FDA Announces New Medical Device User Fees for 2024
On July 28, 2023, the U.S. Food and Drug Administration (FDA) unveiled the latest medical device user fees and annual establishment registration fees, which are set to take effect for Fiscal Year 2024 (FY 2024). These new fees will be applicable from October 1, 2023, and will remain in place through September 30, 2024.
The U.S. Food and Drug Administration is responsible for ensuring the safety and effectiveness of medical devices before they reach the market. In order to fund these regulatory activities, the FDA charges fees from manufacturers and importers of these devices. The funds generated through these user fees play a crucial role in financing the FDA’s oversight of the vast medical device market.
Every year, the FDA reviews and adjusts the user fee rates based on a complex set of factors including inflation, projected workload, and budgetary requirements. The aim is to ensure that the FDA is adequately funded to perform its critical functions while being fair to the medical device industry.
The FDA’s recent announcement underscores its ongoing commitment to ensuring that the medical device industry remains both innovative and safe for consumers. Stakeholders in the medical device sector are urged to familiarize themselves with the latest fees and regulations to ensure smooth operations and compliance in the upcoming fiscal year.
For the most accurate and up-to-date details on the medical device user fees and the annual establishment registration fees for FY 2024, as well as the specifics on the small business fee reductions, we recommend keeping an eye on the Federal Register or the official FDA website.