eMDR System Update

eMDR System Update

eMDR TEST System Adverse Event Codes Update

On March 6, 2018, CDRH plans to update the TEST Electronic Medical Device Reporting (eMDR) system. This update will affect the
following FDA and NCI codes accepted in sections F10 and H6: Device Problem Code (DPC), Manufacturer Evaluation Method Code
(EMC), Manufacturer Evaluation Result Code (ERC), and Manufacturer Evaluation Conclusion Code (ECC). Patient Problem Code (PPC)
and Device Component Code (DCC) will not be affected by this change. New IMDRF-harmonized FDA and NCI codes will be added,
and retired codes will be removed.

This update will take place in the production environment on April 6, 2018. Production eMDR and eSubmitter will receive the update
simultaneously. AS2 submitters must apply code changes to their adverse event complaint handling systems by the production
deployment date. Hardcopy submitters should continue to rely on adverse event code resource files.

Please use the links below to access relevant resources.

MDR Adverse Event Codeshttps://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ReportingAdverseEvents/MDRAdverseEventCodes/default.htm

Coding Resourceshttps://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ReportingAdverseEvents/MDRAdverseEventCodes/ucm584205.htm

eMDR System Enhancementshttps://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ReportingAdverseEvents/eMDR–ElectronicMedicalDeviceReporting/ucm475303.htm

Thanks,
eMDR Team