Between October 1 and December 31 this year, all FDA-registered facilities must renew their registrations. Our team has handled registration renewal for hundreds of facilities. Here are some of our best tips for ensuring the renewal season goes smoothly.
Medical device establishments:
- The process of paying the annual Device Facility User Fee can take a couple of weeks – but pay this $3,382 fee after October 1, or it will apply to FY 2016 instead of next year.
- 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 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:
- There’s no fee for food facility registration renewal. FDA does require, under the Food Safety Modernization Act, any facility involved in the manufacturing, processing, packaging, or importing of a food to register and renew their registrations every even-numbered year.
- Use renewal as an opportunity to review your registration information and ensure it’s all up-to-date.
Tobacco facilities:
- There’s no fee for tobacco facility registration renewal.
- The recent tobacco regulations are shaking things up in the tobacco world – check out the regs or check with FDAImports.com to see if you need to register.
- 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.
