eSubmitter New Version

FDA announced an update to eSubmitter. For device manufacturers, this free software prepares files for submission to the FDA gateway. It includes both MDRs and Correction and Removals reports.

It is not clear from the announcements what will happen to files stored in eSubmitter after updating a manufacturer implements version 3.0.0. Also, eSubmitter interfaces with software to transmit the prepared files to the gateway; the need to revise the interface is not clear.

Software Disposition Notice

The FDA has begun disposition of eSubmitter 2.x.x. The agency will be providing an updated version (3.0.0) of this software in December 2017, which will require a new installation. eSubmitter 2.x.x can continue being used until 5/7/2018, at which point it will be disabled. If you have any questions or concerns please contact the eSubmitter help desk.