About Electronic Medical Device Reporting

For customers using the AECM process within the United States, you can submit an eMDR using the Siebel Business Application. Doing so transmits an XML message in HL7 ICSR format to the FDA. Moreover, you can also manage batch submission, and view their confirmation status by referring to the FDA Status field once they have been submitted.

The FDA has created a single system to accept individual, batch, and summary medical device adverse event reports by way of the FDA electronic gateway server. For additional information about the FDA electronic gateway server and FDA standards for eMDR from the FDA, refer to http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm107914.htm.

For information about eMDR transmission using the Siebel Business Application, refer to Transmitting Electronic Medical Device Reporting Immediately, and Managing Batch Electronic Medical Device Reporting.