Between October 1 and December 31, Food and Drug Administration (FDA)-registered facilities must renew their registrations. Our team has handled registration renewals for hundreds 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 2017 instead of the next year and will not be usable for renewal.
- FDA has not yet finalized the budget and User Fee requirements for the upcoming renewal season, but has proposed that the renewal fee be $4,375. Stay alert and watch for the final decision.
- 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:
- There’s no fee for drug establishment registration renewal.
- The new Center for Drug Evaluation and Research (CDER) Direct submission system has slowed FDA’s response time for confirmations and error help – budget your time accordingly.
- 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.
Tobacco facilities:
- There’s no 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. Contact us today for registration renewal, new facility registration, US agent services and more.
