Between October 1 and December 31, Food and Drug Administration (FDA)-registered facilities must renew their registrations. Our team has handled registration renewals for thousands of facilities. Here are some things you need to know to ensure your renewal is completed on time.
Medical device establishments:
- The process of paying the annual Device Facility User Fee can take a couple of weeks – but don’t pay it before October 1, or it will apply to FY 2024 instead of the next year and will not be usable for renewal.
- FDA has published User Fee requirements for the upcoming renewal season. The User Fee for FY 2025 is $9,280.
- FDA’s system requires users to periodically change their passwords for security reasons – get started on renewal early and ensure you can still access your account.
- Use renewal as an opportunity to review your registration and listing information and ensure it’s all up-to-date.
Drug establishments:
- The OMUFA doesn’t get paid during the renewal year like medical devices and it doesn’t impact a drug facility’s registration, for now. But if you don’t pay the FDA user fee, you get put on FDA’s Arrears list. In addition, all OTC monograph drug products manufactured or processed at your facility (or containing an ingredient manufactured at that facility) shall be deemed misbranded.
- Use renewal as an opportunity to review your registration and listing information and ensure it’s all up-to-date.
Food facilities:
- Food facility registrations need to be renewed this year.
- You will need to pay your U.S. Agent fee annually if you are using FDAImports as your U.S Agent.
- Use renewal as an opportunity to review your registration information and ensure it’s all up-to-date.
Cosmetic facilities:
- Manufacturers and processors must register their facilities with FDA and renew their registration every two years. The responsible person for each cosmetic product must submit a product listing. Listings must be updated annually.
- FDA opened the new electronic submission portal for submitting registration and product listing information in December
- Information in the voluntary cosmetics registration program (VCRP) was not transferred to this new system. Compliance for existing cosmetic facilities and products has been required since July 1, 2024.
Near the end of the renewal season, FDA’s system gets overloaded and FDA personnel go on their Christmas holidays. Don’t wait until December to start the renewal process; that mistake can result in a deactivated registration and an inability to import.
If you have any problems trying to renew using FDA’s electronic registration and listing system, or you aren’t sure what information FDA needs on your submission, our experienced team is here to help. Contact us today for registration renewal, new facility registration, US agent services and more.
This blog 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 FDAImports representative for additional information.
