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.
Systems Index
FURLS Acidified/Low Acid Canned Foods (LACF)
Form 2541/2541d/2541e/2541f/2541g
OMB Approval Number 0910-0037
OMB Expiration Date 10/31/2023
See OMB Burden Statement
FURLS Device Registration & Listing Module (DRLM)
Form 3673
OMB Approval Number 0910-0625
OMB Expiration Date 08/31/2025
See OMB Burden Statement
FURLS Food Facility Registration Module (FFRM)
Form 3537/3537a
OMB Approval Number 0910-0502
OMB Expiration Date 9/30/2025
See OMB Burden Statement
FURLS FSVP Importer Portal for FSVP Records Submission
See System Requirements
FURLS Laboratory Accreditation for Analyses of Foods Program - Accreditation Body (AB)
Form 5040
OMB Approval Number 0910-0898
OMB Expiration Date 01/31/2025
See System Requirements
FURLS Laboratory Accreditation for Analyses of Foods Program - Accredited Laboratory (AL)
Form 5040a
OMB Approval Number 0910-0898
OMB Expiration Date 01/31/2025
See System Requirements
FURLS Shell Egg Producer Registration Module (SEPRM)
Form 3733
OMB Approval Number 0910-0660
OMB Expiration Date 8/31/2025
See OMB Burden Statement
FURLS Voluntary Qualified Importer Program (VQIP)
Form 4041
OMB Approval Number 0910-0840
OMB Expiration Date 09/30/2023
See OMB Burden Statement
Import Trade Auxiliary Communication System (ITACS)
OMB Approval Number 0910-0842
OMB Expiration Date 06/30/2023
See OMB Burden Statement
Prior Notice System Interface (PNSI)
Form 3540
OMB Approval Number 0910-0520
OMB Expiration Date 08/31/2023
See OMB Burden Statement
Food Facility Registration Data Management Support Services (FFRDMSS)
FDA Industry Systems / FDA Unified Registration and Listing Systems (FURLS) / Technical Help
Electronic Submissions Gateway Approved Production Transaction Partners, Food Facility Registration Module, Low Acid & Acidified Canned Foods, and Account Management.
Phone: 1-800-216-7331 or 240-247-8804 9:00 a.m.- 6:00 p.m. Eastern Time
Fax: 301-436-2804 or 1-866-573-0846
Effective January 14, 2004: The Food Facility Registration Data Management Support Services (FFRDMSS) is available for technical assistance with online registration and listing systems, and regulated electronic submissions on U.S. Government business days (Monday to Friday, excluding U.S. government holidays) from 9:00 a.m. to 6:00 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
Phone: 1-866-521-2297
The Prior Notice Center staff can answer questions about Prior Notice policies, procedures, system navigation, 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
Additional Information
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
- 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
System Requirements
- Internet Access Internet access is widely available, including at public libraries and Internet cafes.
- Web Browser The following web browsers are supported by FURLS/PNSI applications.
FURLS- Google Chrome 49.0 or newer
- Mozilla Firefox 43.0 or newer
- Microsoft Internet Explorer (Version 11)
- Microsoft Internet Explorer (Version 9.0)
- Mozilla Firefox 45.0.1
- Google Chrome 49.0 or newer
- Google Chrome 49.0 or newer
- Mozilla Firefox 43.0 or newer
- Microsoft Internet Explorer Edge