The United States Food and Drug Administration
Electronic Medical Device Report (eMDR) Files
Health Level Seven (HL7) Individual Case Safety Reporting (ICSR) Files
- Complete Packet: eMDR_HL7ICSR.zip (Download; Updated September 1, 2015)
- Electronic Medical Device Reporting (Final Rule)
- Medical Device Reporting for Manufacturers
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.
|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|