FDA Industry Systems
Food Facility Registration Module
Prior Notice System Interface
Low Acid Canned Foods
Electronic Submission Gateway
FDA Industry Systems / Technical Help
Electronic Submissions Gateway Approved Production Transaction Partners, Food Facility Registration Module, Prior Notice, Low Acid & Acidified Canned Foods, and Account Management.
Phone: 1-800-216-7331 or 301-575-0156 7:30 a.m.-11:00 p.m. Eastern
Effective January 14, 2004: The FDA Industry System Help Desk is available for technical assistance with online registration and listing systems, Prior Notice, and regulated electronic submissions on U.S. Government business days (Monday to Friday, excluding U.S. government holidays) from 7:30 a.m. to 11:00 p.m. Eastern Time. (See Federal Holidays and Federal Government Operating Status.)
You may leave a message or send e-mail at other times. These will be addressed on the next business day.
Prior Notice / Policy Help
The Prior Notice Center staff can answer questions about Prior Notice policies, procedures, and interpretations 24 hours a day, 7 days a week.
Electronic Submissions Gateway / Pre-Production Help
If you want to become a trading partner, or have a question about
FDA Registration, Listing, or Notification Programs
Other FDA Industry Information
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.