FDA eSubmitter

The Food and Drug Administration’s eSubmitter tool is part of an electronic submissions program that originated in the Center for Devices and Radiological Health (CDRH). The eSubmitter program is the result of two successful pilot programs at CDRH named "eLaser," and "Turbo 510(k)". The current FDA eSubmitter is an improved and expanded package for a variety of submission types and is now available for voluntary use by sponsors, manufacturers, and importers within the blood, device, radiological health, and tobacco regulated industries. The eSubmitter program is designed to minimize redundant data entry while collecting data in a structured format.

FDA eSubmitter is free software to allow for the following submission types:

Center for Devices and Radiological Health (CDRH) to:

• electronically complete and submit premarket notification applications [510(k)] to the CDRH Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
• electronically complete and submit information for a variety of radiation safety Product Reports and Annual Reports for radiation emitting products to the Radiological Health Program
• electronically complete and submit the Medwatch 3500A form for medical device adverse event reports
• electronically complete and submit form 2579 for Report of Assembly of a Diagnostic X-Ray Systems

Center for Tobacco Products (CTP) to:

• electronically complete and submit establishment registration, product listing, ingredient listing and other submissions to CTP

Pilot Only: Center for Biologics Evaluation and Research (CBER) to:

• electronically submit blood related BLA’s as an approved participant in the FDA eSubmitter pilot evaluation program for the Office of Blood Research and Review (OBRR) within CBER. See more information on becoming a pilot participant for CBER.

The FDA eSubmitter tool includes features such as:

• Address / Contacts Books for reuse across submissions
• ability to upload file attachments to the submission or the report
• "Missing Data Report" to validate submission completion
• automatic program updates from FDA when the user’s computer is connected to the Internet (see note below)
• automated acknowledgement message to the submitter upon receipt at FDA

Note: eSubmitter 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. eSubmitter does not transmit any compiled data across the web to FDA. Therefore, 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. See the Quick Guide for packaging and transmission guidelines for participating eSubmitter Programs.

FDA Electronic Submission Gateway (ESG) : CDRH’s Radiological Health submissions program, the eMDR program and CTP utilize the FDA ESG, an agency-wide entry point for all 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.

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 then 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, electronic signatures associated with your changes to the software.