Ensure Proper FDA Facility Registration to Avoid Import/Export Problems
U.S. and foreign 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 domestic and foreign 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.
However, the FDA has observed a significant decrease in the number of registered food and medical device facilities that has been primarily attributed to a failure to renew registrations. 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.
Domestic and foreign food and medical device facilities, as well as the companies that source from them, should ensure those facilities renew their registrations on time. The next renewal period will be open Oct. 1 through Dec. 31. Renewals are mandatory regardless of when the initial registration occurred.
ST&R’s FDA Solutions Group can register facilities, serve as U.S. agent for foreign facilities, and assist with the full range of related functions. For more information, please contact Shelly Garg at (305) 894-1043.