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FDA eSubmitter

FDA eSubmitter

The FDA's eSubmitter software is part of an electronic submissions process that is available for voluntary use by sponsors, manufacturers, and importers to create a variety of submission types within the drug, blood, device, radiological health, tobacco, animal drug and animal food regulated industries.

Description: The FDA eSubmitter is a free software that supports the creation of electronic submissions of the following submission types. The software and any output files reside locally on your computer, allowing you to work on a submission offline, save, and continue later. The eSubmitter tool does not transmit any data across the Web to the FDA. Once you package a submission in eSubmitter, you can securely submit it as noted in the table below. The FDA does not have the ability to access, review, or supplement the information on your local computer through this application.

Please note that the method for sending submissions to the FDA differs based on the Center and submission type being transmitted. The Transmission Method In the table below refers to how submissions are uploaded to the FDA: CD/DVD, other media, or the FDA's Electronic Submissions Gateway (ESG).

Center Office Submission Type Transmission Method
CBER Office of Blood Research and Review (OBRR) Whole Blood and Blood Components including Source Plasma BLA and BLS
Amendments to applications, and Annual Reports
CD
CBER Office of Biostatistics and Epidemiology (OBE) Individual Case Safety Reports (ICSR) Adverse Event Reporting for VAERS. ESG
CDRH Office of In Vitro Diagnostics and Radiological Health (OIR) Assembler Reports (form 2579) ESG
CDRH Office of In Vitro Diagnostics and Radiological Health (OIR) Radiological Health Reports and Correspondence ESG or CD
CDRH Office of Device Evaluation (ODE) and Office of In-Vitro Diagnostic Device Evaluation and Safety (OIVD) eCopies (for marketing and study submissions for medical devices) CD
CDRH Office of Surveillance and Biometrics (OSB) Electronic Medical Device Reporting (eMDR) (form 3500A) ESG
CTP Office of Science (OS) Tobacco Product Ingredient Listing Submissions CTP Portal, ESG*, or CD
CTP Office of Science (OS) Tobacco Product Health Documents CTP Portal, ESG*, or CD
CTP Office of Science (OS) Reporting Harmful and Potentially Harmful Constituents CTP Portal, ESG*, or CD
CTP Office of Science (OS) and Office of Compliance and Enforcement (OCE) Other CTP submission types CTP Portal, ESG*, or CD
CVM Office of New Animal Drug Evaluation (ONADE) All submission types to include (J)INAD, (A)NADA, VMF, and GC files and applications ESG Only
CVM Office of Surveillance and Compliance (OSC) - Division of Animal Feeds (DAF) Investigational Food Additive (IFA) files, Food Additive Petitions (FAP), Generally Recognized as Safe (GRAS) Notices ESG Only
CVM Office of Minor Use and Minor Species Animal Drug Development (OMUMS) Minor Species Index File (MIF) Submissions ESG Only

The FDA's ESG and the CTP Portal are separate from the eSubmitter tool.

  • The ESG is an agency-wide entry point for various electronic submissions. The ESG authenticates and validates electronic submissions and routes it to the appropriate Center.
  • The CTP Portal is used only to transmit submissions to and communicate with the FDA's Center for Tobacco Products (CTP).
    * If you choose, you can still submit to CTP via the ESG. However, the CTP Portal is CTP's preferred alternative to the ESG.

See the Quick Guide for packaging guidelines for participating eSubmitter Programs.

The FDA eSubmitter tool is government-issued software governed by the Government Paperwork Elimination Act of 1998. As a user of this software you are not required to perform your own validation. However, if you decide to use the software for purposes other than the intended uses identified above, you may be required to comply with additional requirements applicable to that intended use. For example, if you store created electronic records locally, for purposes other than an intended use identified above, you may be responsible for additional regulatory requirements including but not limited to validation, change control, and electronic signatures associated with your changes to the software.