FDA Industry Systems
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.
FDA Industry Systems / FDA Unified Registration and Listing Systems (FURLS) / 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 Time
Fax: 301-436-2804 or 1-866-573-0846
To e-mail questions about the Bioterrorism Act use this form
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 becoming a trading partner, for the Electronic Submissions Gateway, please visit the FDA Electronic Submissions Gateway
FDA Registration, Listing, or Notification Programs
- Voluntary Cosmetic Registration Program
- Blood Establishment Registration and Product Listing
- Human Cell and Tissue Establishment Registration and Product Listing
- Drug Registration and Listing
- Medical Device Registration and Listing for Firms
Other FDA Industry Information
- Information for FDA-Regulated Industry
- Information Materials for the Food and Cosmetics Industries
- ORA Industry Assistance
- Small Business Guide to FDA
- Cosmetics - Information for Industry
- Food Ingredients and Packaging - Information for Industry
- Over the Counter Drug Products - Industry Information
- Medical Devices and Radiation-Emitting Electronic Products
- Food Labeling and Nutrition - Information for Industry
- Internet Access Internet access is widely available, including at public libraries and Internet cafes.
- Web Browser The following web browsers, with the exception of Safari, are supported for these applications.
- Microsoft Internet Explorer: Versions 7.0, 8.0 (supported in PNSI and FURLS)
- Mozilla Firefox 3.0 or newer (supported in FURLS only), Mozilla Firefox 3.0.3 (supported in PNSI only)
- Google Chrome 8.0 or newer (supported in FURLS only except TRLM)
- Safari 3.1 (supported in PNSI only)