Background

Foreign and domestic food and medical device facilities that do not properly renew their registrations with the Food and Drug Administration can be locked out of the U.S. market. Renewals for both types of facilities are due this year.

Under the Food Safety Modernization Act, all foreign and domestic facilities that manufacture, process, pack, or store food, food ingredients, pet foods, or dietary supplements are required to renew their registrations with the FDA every even-numbered year. When registering, foreign food facilities must also designate a U.S. agent, a person or entity that is located or maintains an office in the U.S. and acts as the facility’s domestic representative through which all communication with the FDA takes place. U.S. agents must confirm that they have agreed to serve as such and the FDA will not confirm a registration or provide a registration number until the U.S. agent has provided this confirmation.

In addition, owners or operators of establishments involved in the production and distribution of medical devices intended for commercial distribution in the U.S., including those that are imported for export only, must register annually with the FDA. These facilities include foreign and domestic contract manufacturers, specification developers, relabelers/repackers, and initial importers and foreign exporters. Most such establishments must also list the devices they make and the activities performed on those devices at that establishment.

For food facilities, failure to register can result in the facility being prohibited from importing or exporting food into or from the U.S., offering to import or export food into or from the U.S., or otherwise introducing food into interstate or intrastate commerce. Failure to submit, renew, update, or cancel a registration can also result in civil or criminal action. Similar consequences exist for medical device registrations.

Foreign and domestic food and medical device facilities, as well as the companies that source from them, should ensure those facilities renew their registrations on time. The current renewal period opened Oct. 1 and will close Dec. 31. Renewals are mandatory regardless of when the initial registration occurred.

FDA Solutions Group offers facility registration services, including identifying a company's registration obligations and potential exemptions and registering foreign or domestic companies, as well as service as a U.S. agent for foreign facilities. To learn more and ensure your company is registered during the renewal period this year, please contact Domenic Veneziano at (202) 734-3939.

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