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  6. Health Level Seven (HL7) Individual Case Safety Reporting (ICSR) Files
  1. Postmarket Requirements (Devices)

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

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.

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