FDA Industry Systems (FIS) was created to facilitate making submissions to the U.S. Food and Drug Administration (FDA), including registrations, listings, and other notifications. FIS has been available 24 hours a day, seven days a week, since October 16, 2003 6:00 p.m. EDT.
FIS was created, in part, in response to the Bioterrorism Act of 2002, which gave high priority to improved information management to help protect the food supply. The Act requires that FDA develop two systems: one to support the registration of facilities that manufacture, process, pack, or hold food products intended for consumption in the United States and one to receive prior notice before food is imported or offered for import into the United States. Under the law, facilities must be registered by December 12, 2003 when Prior Notice went into effect.