eMDR uses the Health Level Seven (HL7) Individual Case Safety Report (ICSR) standard to receive medical device adverse events reports (MDRs). Each adverse event report is described by an XML document that follows the ICSR XML schema.
Low volume reporters using the ESG WebTrader site will utilize the FDA eSubmitter tool to generate the ICSR-compliant XML. Once entry of the MDR information is completed, the software generates a zip file containing an ICSR -compliant XML file.
High volume reporters using the AS2 Gateway will be required to generate the ICSR XML for each MDR using their own software. Once an AS2 submission system has been set up, they often generate and submit MDRs automatically as part of a firm’s complaint handling process.
The HL7 ICSR message supports the exchange of data and other safety reporting requirements between various public health and patient safety organizations—specifically, reporting of adverse events or product problems associated with the use of drugs, therapeutic biologics, vaccines, and devices.
The parts of the ICSR implemented via eMDR map to the device reporting requirement sections of the current MedWatch Form 3500A. The CDRH files include a “schema” or “file format” to utilize for submission of MDR data as an ICSR message. Reporters can use the specified format to submit MDR data.
Technical specifications for implementation of ICSR for the eMDR project are provided in a package of files. To download the files, please go to Health Level Seven (HL7) Individual Case Safety Reporting (ICSR) Files.