CDRH eMDR changes

Based on the updates to the CDRH regulations, the following changes have been made to Case Form, Argus Console, and eMDR Profile.

• The GTYPEOFREPORT [G7] element is now repeatable within the GREPORTTYPE [G7] node. Mappings and allowed values for this element have been revised to distinguish between the Thirty Day report and Initial report.
• The Concept Codes for the DECHALLENGE [C9] and RECHALLENGE [C10] elements have been updated to C86045 and C54055, respectively.
• The list of allowed values for the LOCATIONEVENTOCCUR [F12] element has been updated according to the latest regulations. Mapping changes have been made to the LOCATIONEVENTOCCUR [F12] and LOCATIONEVENTOCCURTEXT [F12] elements.
• The list of allowed values for the APPROXDEVICEAGETEXT [F9] element has been updated to include the Week unit. The Age Unit codelist and DEVICE_AGE_UNIT flexible codelist have been updated to enable the Week unit to appear under Case Form > Product > Device > Device Age field.
• The list of allowed values for the following elements has been updated according to the latest regulations:
  • FDAPATIENTCODE [F10]
  • MFRPATIENTCODE [H6]
• Mapping for UDINUMBER [D4] has been updated to populate data based on the new UDI-DI field added to the Device tab. If this data is missing, data is populated based on existing logic, using the Unique Device Identifier field in the Device tab.
• Data Length for the following eMDR elements has changed according to the latest guidelines:
  • MFRCONTACTFACILITY [G1]
  • CONCOMPRODUCTNAME [D11]
• The Email Address field has been added to Case Form > Analysis > MedWatch Info > F. For Use by User Facility/Importer (Devices Only). The UFCONTACTEMAIL [F3] element has been added to the eMDR Profile to populate data from the User Facility’s Email Address field.
• Mapping for USAGEOFDEVICE [H8] has been updated to send appropriate NCI codes if the Unknown value is selected in the Usage of Device field.

For changes to the Case Form fields and Argus Console fields, see Oracle Argus Safety8.2.2 CaseForm_Console_Updates_Summary sheet.

For mapping changes, see eMDR (R2) Export Mappings sheet.