FDA Industry Systems (FIS) is a gateway for 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.
The first of these FDA Industry Systems to be available was the Food Facility Registration Module (FFRM) for the electronic Registration of Food Facilities. FFRM is the initial component of the FDA Unified Registration and Listing System (FURLS) which will be expanded in the future to provide central access to all FDA registration and listing systems such as those listed on the left.
The Prior Notice System Interface, PNSI, came on-line December 12, 2003. PNSI allows individuals to submit prior notice through an on-line web interface. Prior Notice for shipments through international mail must be submitted through PNSI. Brokers and other filers engaged in importing food products other than through the mail can choose to submit prior notice through PNSI or through the Bureau of Customs and Border Protection (CBP). CBP's Automated Commercial System (ACS) has been enhanced to accept the prior notice information required by FDA.
All that is needed to use FIS is an Internet connection and a web browser. (See browser requirements below.) |