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        For Industry

FDA eSubmitter

                        
                CBER eSubmitter Program
          CDRH eSubmitter Program
          Using eSubmitter to Prepare Tobacco Product Submissions
          eSubmitter Download and Installation
          eSubmitter Tutorial Videos
          Contact eSubmitter
          CVM eSubmitter Programs
          eSubmitter Application History Home
          For Industry
          FDA eSubmitterFor Industry FDA eSubmitter
  	
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    PrintThe 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, online portal, or the FDA's Electronic Submissions Gateway (ESG).

Center
			Office
			Submission Type
			Transmission MethodCBER
			Office of Blood Research and Review (OBRR)
			Whole Blood and Blood Components including Source Plasma BLA and BLS
			Amendments to applications, and Annual Reports
			CDCBER
			Office of Biostatistics and Epidemiology (OBE)
			Individual Case Safety Reports (ICSR) Adverse Event Reporting for VAERS.
			ESGCDRH
			Office of Product Evaluation and Quality (OPEQ), Office of Health Technology 8 (OHT8)
			Radiological Health Reports and Correspondence
			Submitting Reports and requirements for Maintaining Records for Radiation, ESGCDRH
			Office of Product Evaluation and Quality (OPEQ)
			eSTAR or eCopy (for premarket submissions for medical devices)
			CDRH Portal, 
			CD/DVD/USBCDRH
			Office of Product Evaluation and Quality (OPEQ)
			Electronic Medical Device Reporting (eMDR) (form 3500A)
			ESGCTP
			Office of Science (OS)
			Tobacco Product Ingredient Listing Submissions
			CTP Portal, ESG*, or CDCTP
			Office of Science (OS)
			Tobacco Product Health Documents
			CTP Portal, ESG*, or CDCTP
			Office of Science (OS)
			Reporting Harmful and Potentially Harmful Constituents
			CTP Portal, ESG*, or CDCTP
			Office of Science (OS) and Office of Compliance and Enforcement (OCE)
			Other CTP submission types
			CTP Portal, ESG*, or CDCVM
			Office of New Animal Drug Evaluation (ONADE)
			All submission types to include (J)INAD, (A)NADA, VMF, and GC files and applications
			ESG OnlyCVM
			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 OnlyCVM
			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.

                                                                                  Content current as of:
      10/16/2023FDA eSubmitter                
                          

                        CBER eSubmitter Program
          CDRH eSubmitter Program
          Using eSubmitter to Prepare Tobacco Product Submissions
          eSubmitter Download and Installation
          eSubmitter Tutorial Videos
          Contact eSubmitter
          CVM eSubmitter Programs
          eSubmitter Application History
 
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