FDA eMDR regulation updates

Summary

FDA eMDR enhancements 2022 (Enhancement 34749011)

Description

CDRH has published revised guidance for eMDR in August 2022, which is effective from March 2023.

The following changes have been made in the application based on the regulation updates:

• The size of the FDA Exemption number field in Case Form > Product Information > Device information is increased from 7 to 10.
• The country name for MACEDONIA, THE FORMER YUGOSLAV REPUBLIC OF within the Country code list is changed to NORTH MACEDONIA as per the ISO specification.
• The data length of the element EXEMPTIONNO is extended from 7 to 10 in eMDR profile.
• The DESCRIPTION DESCRIPTION_J data in CFG_M2 for the following elements in eMDR profile is changed from MACEDONIA, THE FORMER YUGOSLAV REPUBLIC OF to MACEDONIA as per GENC3 standards that is applicable for eMDR report.
  • FMFRCOUNTRY[F14]
  • MFRCONTACTCOUNTRYCODE[G1]
  • MFRCOUNTRY[D3]
  • REPORTERCOUNTRYR3[E1]
• The data element number for UFCONTACTEMAIL is changed from [F3] to [F4].
• The following new validations are provided in the eMDR profile:
  • UFCONTACTEMAIL[F4]
  • MFRCONTACTEMAILADDRESS [G1]
  • FDAPATIENTCODES [F10 Part 1]
  • FDADEVICECODES [F10 Part 2]
  • MFRPATIENTCODE[H6]
  • MFRDEVICECODE[H6]
• The validation on the TYPEOFDEVICENAME[D2] element is removed from the eMDR profile.
• The validation for the TYPEOFREPORTABLEEVENT[H1] element is revised to be applicable only for the initial report (Enhancement 29681544).