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).
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.
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.
Download Software
To download the FDA eSubmitter software, click on the following link.
Way to Install
Save the installation zip file to your computer and extract the jinstall.exe file. Double-click the jinstall.exe file to run the installation. Follow the instructions provided in the installation wizard.
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Download eSubmitter Software
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Download User Manual (Updated June 2009)
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Download Quick Guide (Updated June 2009)
