eMDR 2023 Regulation updates

Summary

FDA eMDR system enhancements 2023 (Enhancement 36057701)

Description

CDRH has published revised guidance for eMDR in September 2023, which is effective from March 2024. The Argus application is enhanced to comply with the latest guidance updates.

Console changes

The Gender code list is updated with NCI codes for the new values that are supported in eMDR.

Codelist value	NCI Code
Cisgender man/boy	C46109
Cisgender woman/girl	C46110
Transgender man	C46121
Transgender woman	C46120
Undifferentiated	C41438

In System Configurations > Common Profile Switches > Reporting > Expedited – MedWatch > MedWatch Configuration, Default Text to Appear on Block H10 is renamed as Default Text to Appear on H10 - MW device / H11- eMDR.

UF/Importer Report # is added to the Reference Type code list.

Interchange mapping changes

The following elements are added to the eMDR profile:

• PATIENTGENDER (A3b)
• RELATEDREPORTEDNUMBER (H10)

The element numbers are renamed for the following elements:

• PATIENTSEXR3
• TYPEOFDEVICENAME
• TYPEOFDEVICECODE
• ADDMFRNARRATIVE

The length for the following elements are increased:

• MFRREPORTNUMBER (G8)
• USCNUMBER (H9)

The following elements are removed from the eMDR profile:

• DEVICEEVALSUMMARYATTACH (H3)
• DEVICENOTEVALUATEDREASON (H3)
• DEVICENOTEVALUATEDREASONOTHER (H3)
• DEVRETURNTOMFR (H3)

The mapping logic are revised for the following elements:

• THIRDPARTYSERVICED (D8) - Inclusion of Null flavor UNK
• UFREPORTNUMBER (F2) is generated for the final eMDR report by concatenating the HCFA number entered in the Device Company Identification Reporting Destination > Agency Information > Registration #, Year, and a 4-digit Seq_num in the format: RRRRRRRRRR-CCYY-SSSS.

  This is auto-generated for each of the devices for which a report is scheduled when the destination is marked as Importer/Distributor [Bug ID: 32448693].

• BATCHMESSAGENUMB for user facilities reports, this element is populated by concatenating the HCFA number entered in the Device Company Identification Reporting Destination > Agency Information > Registration # and Year, and local system date (database) in the CCYYMMDDhhmmss format.

Validation message updates:

• TYPEOFDEVICECODE[D2b] - The validation message The value of UF/Importer Report Number (F2) for a report belonging to another case. is removed.

Case form changes

• The length of the Device tab > MW Info > 21 USC 360i(f) correction /removal reporting number field is increased from 24 to 50 characters.
• The UF/Dist report # field is made read-only field as it is computed on generation of the final report. This information is saved in Case form > Additional Information > References.

For more information, refer to the ArgusSafety843_CaseForm_Console_Updates_Summary.xlsx and ArgusInterchange843_eMDR (R2) Export Mappings.xlsx.