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 2023 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 2024 is $7,653.
- 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 Over-The-Counter Monograph Drug User Fee (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 can expect to be added to FDA’s Arrears list (which is basically a no-no list). There are no fines or voided registrations yet; however, we encourage you to pay the user fee because FDA publishes that list and any buyer of OTC drugs can see who is on it and choose not to buy your products.
- 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 do not need to be renewed this year. These registrations are valid for two years and need to be renewed in the even-numbered years.
- You will need to pay U.S. Agent fee annually if you are using FDAImports as your U.S Agent.
Cosmetic facilities:
- FDA ended the previous voluntary registration program as of March 27, 2023, and FDA intends to make the new electronic submission portal available for submitting registration and product listing information in October 2023.
- Information in the voluntary cosmetics registration program will not be transferred to this new system. Compliance for existing cosmetic facilities and products is required by Dec. 29, 2023.
- Manufacturers and processors must register their facilities with FDA and renew their registration every two years. Listings must be updated annually.
Tobacco facilities:
- There’s no FDA fee for tobacco facility registration renewal.
- Use renewal as an opportunity to review your registration and listing information, and to ensure it’s all up-to-date and active.
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.
Our team at FDAImports is experienced with filing FDA facility registrations as well as with troubleshooting problems that may arise in the process. 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.
