Medical Devices

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

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

The following provides a description of each of these files.

File NameContents
ReadMeFirst Release.xls

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.docTechnical specifications to be used to implement a high volume submitting solution. Also contains information on Acks.
HL7Medwatch.xls3500A_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.xlsICSR diagrams for CDRH implementation
Con061019.xsdPrimary 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.xsdSecondary XML schema files referenced by Con.xsd during XML validation
3500A_Sample_HL7_Submission.xmlExample 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.pdfThe human-friendly 3500A PDF representation of the example XML file (see mappinginstance.xml).
sample_attachment.pdfThis file provides the sample document used as an attachment to the mappingInstance.xml.
Ack3Schema.xsdSchema document for Acknowledgment 3 in xml format
ACK3_SUCCESS_Single_Report.html, ACK3_SUCCESS_Single_Report.xmlSample Ack3 file for a single report submission that passes
ACK3_SUCCESS_Multiple_Reports.html, ACK3_SUCCESS_Multiple_Reports.xmlSample Ack3 file for multiple report submission via a batch file that passes
MFR_REPORT_ALL_DATA_2_ACK3_FAILURE.html, Ack3SampleFail.xmlSample Ack3 file for a submission that fails with invalid content
ACK3_PARTIAL_FAILURE_PARTIAL_PASS.html, ACK3_PARTIAL_FAILURE_PARTIAL_PASS.xmlSample Ack3 file with at least one report that failed and at least one report that passed.
ACK2_SUCCESS.txtSample Ack2 file from CDRH


Page Last Updated: 09/01/2015
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