The Food and Drug Administration's eSubmitter tool is part of an electronic submissions program 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 and animal drug regulated industries.
Description: The FDA eSubmitter tool is a stand-alone application that allows the input of data and compilation of an FDA-compatible output submission file. The application and any output files reside locally on your computer allowing users to work on a submission offline, save, and continue later. The eSubmitter tool does not transmit any compiled data across the web to FDA. It is the responsibility of each user for the security of the application and data contained within it. The FDA does not have the ability to access, review, or supplement the information on your local computer through this application.
The FDA eSubmitter is a free software that currently supports the creation of the following submission types. Please note that the method for sending completed submissions to FDA differs based on the Center and submission type being transmitted. The Transmission method refers to the FDA's Electronic Submissions Gateway, or 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
|CBER||Office of Biostatistics and Epidemiology (OBE)||Individual Case Safety Reports (ICSR) Adverse Event Reporting for eVAERS Pilot Testing||Gateway|
|CBER / CDER||Office of Compliance and Biologics Quality (OCBQ)|
Office of Compliance (OC)
|Generic Drug Facility Electronic Self-Identification||Gateway|
|CDER||Office of Surveillance and Epidemiology (OSE)||Drug Adverse Event Report||Gateway|
|CDRH||Office of Compliance (OC)||Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program||Gateway|
|CDRH||Office of In Vitro Diagnostics and Radiological Health (OIR)||Assembler Reports (form 2579)||Gateway|
|CDRH||Office of In Vitro Diagnostics and Radiological Health (OIR)||Radiological Health Reports and Correspondence||Gateway |
|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)||Gateway|
|CTP||Office of Compliance and Enforcement (OCE)||Establishment Registration and Product Listing||Gateway |
|CTP||Office of Science (OS)||Tobacco Product Ingredient Listing Submissions||Gateway or CD|
|CTP||Office of Science (OS)||Tobacco Product Health Documents||Gateway or CD|
|CTP||Office of Science (OS)||Reporting Harmful and Potentially Harmful Constituents||Gateway or CD|
|CTP||Office of Science (OS) and OCE||CTP submission types not listed above (ESG transmittal form)||Gateway 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||Gateway Only|
FDA's ESG is 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. Please visit http://www.fda.gov/esg/ to register as a trading partner for an initial ESG test account. Upon successful transmission of the test submission, your account will be promoted to a production account and you can start submitting required documents to FDA electronically.
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.