1. FDA eSubmitter (formerly referred to as CDRH eSubmitter or CeSub) Software
The eSubmitter program is a free, downloadable application that allows users to create one report at a time. With eSubmitter, the user manually enters the required MDR information into the eSubmitter program. The program contains data elements that correspond with 21 CFR 803.32, 803.42, and 803.52, and generates the .xml message, in HL7 ICSR format, needed to successfully transmit the report via the ESG.
The eSubmitter program allows the user to print a copy of the submitted report(s) and allows the attachment of labeling or other documents to the initial report or to a supplemental or follow-up report.
2. Health Level Seven (HL7) Individual Case Safety Reporting
This option provides the capability to create and submit eMDRs either individually or in batches (containing multiple individual reports in a single submission). Entities who choose this option are encouraged to develop systems that can save or print the resultant report and that can encode attachments into their eMDRs.
