The United States Food and Drug Administration

Electronic Medical Device Report (eMDR) Files

Health Level Seven (HL7) Individual Case Safety Reporting (ICSR) Files

The FDA/CDRH staff has created a packet of files to assist in implementing software for generating the HL7 ICSR XML for an eMDR submission.
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FDA eSubmitter Download

To download the FDA eSubmitter software, click on the following link.  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.

  • Download eSubmitter Software, Manual, Guide and FAQ here >>

FDA Warning Letters for MDRs

The following provides a description of each of these files.

File Name Contents
This displays when logged in There are two sheets in this file. The mm.dd.yyyy in the file name indicates the date of the most recent update.

ReadMe Sheet – Provides an overview of all the files in the package

ChangeLog Sheet – Documents all changes made to the files in the package with the exception of the HL7Medwatch.xls file, which has its own ChangeLog sheet for ease of use

ICSRImplTechSpecv1_1Release.doc Technical specifications to be used to implement a high volume submitting solution. Also contains information on Acks.
HL7Medwatch.xls 3500A_HL7 Sheet – Lists each MedWatch element, current instructions, HL7 pointers, and field lengths
Vocabulary Sheet – Lists all the vocabulary items required by the ICSR message
X_Path Sheet – Used to find the particular nodes in the XML document that are used in the 3500A form
ICSRDiagrams.xls ICSR diagrams for CDRH implementation
Con061019.xsd Primary XML schema file to which all eMDR HL7 XML will be validated.  Note that this file is also available in the implementation package under the eMDRHL7\coreschemas folder.
datatypes.xsd, datatypes-base.xsd, infrastructureRoot.xsd, voc.xsd, narrativeBlock.xsd Secondary XML schema files referenced by Con.xsd during XML validation
3500A_Sample_HL7_Submission.xml Example MDR submission XML. Your MDR submission should look similar to this. This file is a sample HL7 message validated against the Con061019.xsd schema file.
When creating your own messages, the data may change from one message to the next, but the structure should stay the same.
3500A_Sample_HL7_Submission.pdf The human-friendly 3500A PDF representation of the example XML file (see mappinginstance.xml).
sample_attachment.pdf This file provides the sample document used as an attachment to the mappingInstance.xml.
Ack3Schema.xsd Schema document for Acknowledgment 3 in xml format
ACK3_SUCCESS_Single_Report.html, ACK3_SUCCESS_Single_Report.xml Sample Ack3 file for a single report submission that passes
ACK3_SUCCESS_Multiple_Reports.html, ACK3_SUCCESS_Multiple_Reports.xml Sample Ack3 file for multiple report submission via a batch file that passes
MFR_REPORT_ALL_DATA_2_ACK3_FAILURE.html, Ack3SampleFail.xml Sample Ack3 file for a submission that fails with invalid content
ACK3_PARTIAL_FAILURE_PARTIAL_PASS.html, ACK3_PARTIAL_FAILURE_PARTIAL_PASS.xml Sample Ack3 file with at least one report that failed and at least one report that passed.
ACK2_SUCCESS.txt Sample Ack2 file from CDRH

Source: FDA

FDA Electronic Medical Device Reporting and eMDR Files
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