IMDRF 2023 updates

Summary

IMDRF 2023 Updates (Enhancement 36057359)

Description

IMDRF released AER Terminology codes annexures (A-G annexures) in March 2023, followed by FDA releasing Annexures by for the updated FDA codes in August 2023.

IMDRF Repository updates for Annex A-F

The CFG_FDA_IMDRF_CODES repository has been enhanced as specified below:

• Annex A
  • Added terms: A2501, A0514, A050408, and A0723
  • Modified terms: A050405, A07, A14, and A1412
  • Retired term: A071205
• Annex B
  • Added term: B25
  • Modified terms: B15, B16, and B24
• Annex C
  • Added terms: C0109, C0210, C0708, C2301, C2302, and C24
  • Modified terms: C1302 and C160504
• Annex D
  • Added terms: D20 and D21
• Annex E
  • Added terms: E0209, E0520, E0624, E0625, E0626, E0627, E0854, E0855, E0856, E0857, E1212, E1312, E1313, E1314, E1419, E1420, E1727, E2124, and E2343
  • Modified terms: E040202, E0607, E0824, E0827, E0845, E120501, E1308, E2012, E2302, E2322, and E2401
• Annex F
  • Added term: F2307
  • Modified terms: F11, F19, F1907, F2202, and F24

Device Component Repository updates for Annex G

The DEVICE_SUBCOMPONENTS flexible code list has been enhanced as specified below:

• Annex G
  • Added terms: G0200804, G03014, G03015, and G03016
  • Modified terms: G0200401 and G04097

CFG_M2 Repository updates

The Allowed Value repository (CFG_M2 table) for eVAERS and FDA 2.2 DTD profile has been updated.

For details on the new and updated values, refer to the OracleArgusSafety842_CaseForm_Console_Updates_Summary.xls