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 Biologics Export Certification Application & Tracking System (BECATS)
Form 3613
OMB Approval Number 0910-0498
OMB Expiration Date 04/30/2024
See OMB Burden Statement

FURLS Export Listing Module (ELM)

Form 3972
OMB Approval Number 0910-0509
OMB Expiration Date 08/31/2025
See OMB Burden Statement

FURLS CDER Export Certification Application & Tracking System (CDER eCATS)
Form 3613
OMB Approval Number 0910-0498
OMB Expiration Date 04/30/2024
See OMB Burden Statement

FURLS CDRH Export Certification Application & Tracking System (CECATS)

Form 3613, 3613a, 3613c and 3613g
OMB Approval Number 0910-0498
OMB Expiration Date 04/30/2024
See OMB Burden Statement

FURLS CFSAN Export Certification Application & Tracking System (CFSAN eCATS)
Form 3613d/3613e/3613k
OMB Approval Number 0910-0793
OMB Expiration Date 08/31/2024
See OMB Burden Statement

FURLS CVM Export Certification Application & Tracking System (CVM eCATS)
Form 3613, 3613a, 3613b
OMB Approval Number 0910-0498
OMB Expiration Date 04/30/2024
 

FURLS Device Registration & Listing Module (DRLM)
Form 3673
OMB Approval Number 0910-0625
OMB Expiration Date 08/31/2025
See OMB Burden Statement

FURLS Electronic Biological Product Deviation Report (eBPDR)
Form 3486/3486A
OMB Approval Number 0910-0458
OMB Expiration Date 02/28/2026
 

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 Qualified Facility Attestation (QFA)


Form 3942a/3942b
OMB Approval Number 0910-0751
OMB Expiration Date 11/30/2024
See OMB Burden Statement

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 Third-Party Program - Accreditation Body Module (AB)
Form 3997
OMB Approval Number 0910-0750
OMB Expiration Date 08/31/2025
See OMB Burden Statement

FURLS Third-Party Program - Certification Body (CB)
Form 3997a
OMB Approval Number 0910-0750
OMB Expiration Date 08/31/2025
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 0910-0046
OMB Expiration Date 08/31/2026
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

Validate FDA CVM Export Certificates (FECV)


See System Requirements

Observation and Corrective Action Report (OCAR) Industry Portal


See System Requirements

CDER Office of Manufacturing Quality (CDER OMQ e-Portal)


See System Requirements

Validate FDA CDRH Export Certificates (FECV)


See System Requirements

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

Account Management Help Electronic Submissions Gateway Help

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

System Requirements

  1. Internet Access Internet access is widely available, including at public libraries and Internet cafes.
  2. 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)
    PNSI
    • Microsoft Internet Explorer (Version 9.0)
    • Mozilla Firefox 45.0.1
    • Google Chrome 49.0 or newer
    FECV
    • Google Chrome 49.0 or newer
    • Mozilla Firefox 43.0 or newer
    • Microsoft Internet Explorer Edge

Page Last Updated: 1/2/2024
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