US Establishment Registration Renewals

US Establishment Registration Renewals

It’s that time of year again! Any domestic and foreign establishments registered with US FDA must renew their registration annually between October 1st and December 31st. Even facilities that registered as late as September 30th, 2021 are still required to renew their registration. 

Facilities located outside of the U.S. must also designate a U.S. Agent to communicate with the FDA on their behalf. The FDA will not finalize a facility’s renewal until the U.S. Agent accepts the designation. Failure to renew a facility registration during the renewal period could result in the cancellation of the registration.

Drug Facilities

When an establishment registration renewal is filed with the FDA, the facility identifier will remain the same after the renewal. Drug manufacturers must have at least one drug listing with the FDA to keep their establishment registration and NDC label code active. 

Medical Device Facilities

Foreign manufacturers of medical devices whose products are available in the US Market must identify all US Importers at the time of registration renewal. US Importers are required to identify all foreign manufacturers at the time of registration renewal. 

Food Facilities

Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires food facilities that are registered with FDA to renew such registrations during the period beginning on October 1 and ending on December 31 of each even-numbered year (2020, 2022, 2024, etc.). Therefore, food facility registrations will need to be renewed next year.

How We Can Help

Our Experts at Quality Smart Solutions can offer US regulatory compliance services for dietary supplements, foods, cosmetics, OTC drugs and medical devices.

Contact us today to learn more about how we can support your compliance needs during and after licensing!

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