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This is a reminder that the FDA renewals for both food facilities and medical devices are due by December 31, 2020. All domestic and foreign food and medical device facilities, along with the companies that source from them, are required to renew their registration this year.

Food Facilities:

The Food Safety Modernization Act requires that all domestic and foreign facilities that process, pack, manufacture, or store food, food ingredients, dietary supplements, or pet foods renew their registrations with the FDA every even-numbered year. Please also remember that all foreign facilities must designate a U.S. agent that is located or has an office in the U.S. as their representative. The U.S. agent must confirm that they have agreed to serve and will be the primary liaison for all communication with the FDA.

Please click here for Food Facility Registration.

Medical Devices:

All domestic and foreign facility owners and operators involved in the distribution and production of medical devices intended for commercial distribution in the U.S. (including manufacturers, developers, relabelers, packers, initial importers, and foreign exporters) must register annually. In most cases, these facilities must also list the devices they produce and the activities performed on those devices at each establishment.

Please click here for Medical Device Registration.

Failure to renew prior to the December 31 deadline will cause import delays and can result in criminal or civil action.

For more information, please contact your local Noatum Logistics USA representative.