Between October 1 and December 31, Food and Drug Administration (FDA)-registered facilities must renew their registrations. 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 2018 instead of FY 2019 and will not be usable for renewal.
- FDA’s User Fee will be $4,884 for FY 2019 renewal season.
- 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:
- Facilities that are filing for registration renewal must also review and file an update to their drug product listings – even if the filing says, “no changes.”
- 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 must be renewed this year. These registrations are valid for two years and need to be renewed between October and December of every even-numbered year.
Tobacco facilities:
- Use renewal as an opportunity to review your registration and listing information, and to ensure it’s all up-to-date and active.
Registration and listing can be a complex, tedious process, involving some legal analysis and requiring you to create accounts on multiple government websites and match data in obscure databases. If you have any problems trying to renew using FDA’s electronic registration and listing systems, 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, U.S. Agent services and more.
