Food & Medical Device Registration Renewals Due By end of 2024

Registrations for all foreign and domestic food and medical device facilities are due by the end of this year. Any facility that fails to properly renew their registration with the Food & Drug Administration (FDA) is at risk of being closed out of the U.S. market. 

Under the Food Safety Modernization Act, all facilities that manufacture, process, pack, or store food, food ingredients, pet foods, or dietary supplements must renew their registrations with the FDA every even-numbered year. Domestic entities may register themselves, but foreign entities must designate a U.S. agent that will act as their representative for all FDA communications. The FDA will only confirm registration once it has received confirmation from the U.S. agent. 

All entities involved in the production and distribution of medical devices intended for commercial distribution in the U.S. must register each year with the FDA. Qualifying businesses include foreign and domestic contract manufacturers, specification developers, relabelers or repackers, and initial importers and foreign exporters. In many cases, these businesses are also required to list out the devices they make and the purpose of those devices.  

Failure of either of these types of businesses to register or renew their registration can result in consequences ranging from being prohibited from importing or exporting their product into or out of the U.S. to civil or criminal action. 

Please reach out to your Scarbrough representative if you have any questions or need assistance with registration.