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FDA Renewal Period Approaching

The next FDA Renewal period begins October 1, 2018. All domestic and foreign food and medical device facilities, along with the companies that source from them, are required to renew their registration during the period from October 1, 2018 through December 31, 2018. 

Food Facilities:

The Food Safety Modernization Act requires all domestic and foreign facilities that process, pack, manufacture or store food, food ingredients, dietary supplements, or pet foods to renew their registrations with the FDA every even numbered year. Further, 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.

Click here for details regarding Food Facility Registration.

Medical Devices:

All domestic and foreign facility owners and operators, including manufacturers, developers, re-labelers, packers, and initial importers and foreign exporters involved in the distribution and production of medical devices intended for commercial distribution in the U.S. 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.

Click here for details regarding Medical Device Registration.

Failure to renew by the December 31, 2018 deadline will cause import delays and can result in criminal or civil action.

For additional information, contact your local MIQ Logistics representative.