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In this section: Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities

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.

Complete Packet: eMDR Implementation Package (ZIP - 2.51 MB, Updated Augus 26, 2024)

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

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