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.

This packet is separated into 2 separate folders – one for ICSR R1 format submissions and another for ICSR R2 format submissions.

Please read the "ReadMeFirst" file in each folder for more information on the individual files contained in the folder.

Page Last Updated: 06/26/2017
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