The U.S. Food and Drug Administration (FDA) has announced its new medical device user fees for fiscal year 2025, effective October 1, 2024, highlighting significant updates aimed at strengthening regulatory oversight and ensuring the safety and efficacy of medical devices.
The FDA’s user fee program is designed to generate necessary resources for the agency’s regulatory activities, including premarket review, compliance checks, and post-market surveillance. For FY 2025, the FDA’s new device fee fiesta includes adjusted fees across several categories, including:
- Premarket Application Fees
- Establishment Registration Fees
- Device Listing Fees
Key Changes in Device Registration Fees
Fee Increase
For FY 2025, the FDA has proposed a notable increase in device registration fees, from $7,653 (FY 2024) to $9,280 (FY2025). This adjustment is intended to better align with the actual costs incurred by the agency in managing the registration process and ensuring compliance with regulatory standards. The increased fees are expected to support enhanced regulatory activities and help FDA increase the efficiency of its review process.
Tiered Fee Structure
To address the diverse landscape of the medical device industry, the FDA continues to implement a tiered fee structure. This system categorizes fees based on the size of the business:
- Small Businesses: Qualifying small businesses will continue to benefit from reduced registration fees, easing the financial burden and encouraging innovation and market entry for new players.
- Large Corporations: Larger entities continue to be subject to higher fees, reflecting their greater capacity to absorb these costs.
Annual Registration Requirement
As a reminder, all device companies subject to the device registration requirements (manufacturers, specification developers, foreign exporters, device initial importers and more) are required to renew their device registration for the next fiscal year, beginning October 1. This requirement aims to maintain an accurate and up-to-date registry of medical devices, facilitating more efficient monitoring and faster response times in case of recalls or safety issues.
As a significant number of FDA import detentions and refusals for medical devices center on facilities lacking the requisite medical device registration and device listing, we remind affected businesses that the failure to register a medical device facility is a prohibited act, and may result in enforcement actions, including injunction or prosecution. FDA regulations provide that the failure of a device establishment to register with the FDA causes the devices manufactured or processed in such an establishment to be misbranded, and therefore subject to refusal of admission.
We remind businesses to continue to be fee-nomenal and get ahead on compliance! We recommend understanding and incorporating the new fee changes for planning purposes, and ensuring timely compliance to mitigate FDA enforcement issues.
For more information on the new FDA medical device user fees, FDA device registration and listing, or for general questions on medical device compliance, please contact us at info@garg-law.com.
