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 2541/2541a/2541c
OMB Approval Number 0910-0037
OMB Expiration Date TBA
See OMB Burden Statement

FURLS Biologics Export Certification Application & Tracking System (BECATS)
FDA 3613
OMB Approval Number 0910-0498
OMB Expiration Date 03/31/2015
See OMB Burden

FURLS CDRH Export Certification Application & Tracking System (CECATS)
FDA 3613
OMB Approval Number 0910-0498
OMB Expiration Date 03/31/2015
See OMB Burden

FURLS CFSAN Certificate Application Process (CAP)
FDA 3613d/3613e
OMB Approval Number 0910-0793
OMB Expiration Date 05/31/2018
See OMB Burden

FURLS Device Registration & Listing Module (DRLM)
Form 3673(03/08)
OMB Approval Number 0910-0625
OMB Expiration Date 03/31/2012
See OMB Burden Statement

FURLS Food Facility Registration Module (FFRM)
Form 3537/3537a
OMB Approval Number 0910-0502
OMB Expiration Date 08/31/16
See OMB Burden Statement

FURLS New Dietary Ingredient Notification (NDIN)
Form 3880
OMB Approval Number 0910-0330
OMB Expiration Date 03/31/2018
See OMB Burden Statement

FURLS Shell Egg Producer Registration Module (SEPRM)
Form 3733
OMB Approval Number 0910-0660
OMB Expiration Date 08/31/2016
See OMB Burden Statement

FURLS Tobacco Registration and Product Listing (TRLM)
FDA 3741
OMB Approval Number 0910-0650
OMB Expiration Date 10/31/2015
See OMB Burden

Prior Notice System Interface (PNSI)

Form 3540
OMB Approval Number 0910-0502
OMB Expiration Date 06/30/2017
See OMB Burden Statement

Help Desk

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

Account Management Help Electronic Submissions Gateway Help

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

Phone: 1-866-521-2297

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

System Requirements

  1. Internet Access Internet access is widely available, including at public libraries and Internet cafes.
  2. 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)

Page Last Updated: 07/25/2015
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