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 evolved as a result of two very successful pilot programs at CDRH named "eLaser," and "Turbo 510(k)".  FDA eSubmitter is an improved and expanded package for a variety of submission types and is now available for voluntary use by the sponsors and manufacturers in the device and Radiological Health and blood regulated industries. FDA eSubmitter is free software intended to allow sponsors to:

• electronically complete and submit premarket notification applications [510(k)] to the 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
• 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 the Center for Biologics Evaluation and Research (CBER). See more information on becoming a pilot participant for CBER.

The FDA eSubmitter tool includes previously tested features such as the semi-automatic acknowledgement message to the submitter and manufacturer, the Address Book and Contacts Book, PDF files as attachments to the Submission or the Report, the "Missing Data Report," and the ability to save submissions or reports to your hard-drive. There are new features including multiple PDF attachments, improved "Create a Submission" procedure, and more "help" and guidance information. Also, this software is capable of providing automatic updates from the FDA website each time the user opens the application when connected to the Internet. This software application is intended to automate the current paper submission process to the OIVD, Rad Health and Medical Device Adverse Event (MDR) 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 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, on a non-government computer, you may be responsible for additional regulatory requirements including but not limited to validation, change control, electronic signatures associated with you changes to the software. 

This software contains a number of data capturing tools and helpful dialog boxes to reduce redundant responses from you, and to allow us to capture data in a more useful, structured format. These benefits will improve our review process and reduce lengthy review times at the OIVD and Rad Health Programs. Please feel free to download the software using the nearby link to Download and Installation.