# FDA eMDR Generation Data Mapping Learn how Vault generates the FDA eMDR XML file from a _Case_. For details about other supported FDA formats, see FDA Report Formats. ## Prerequisites Your Admin must enable FDA eMDR Generation & Manufacturing Report Number Automation. Optional: To use IMDRF codes, your Admin must enable the IMDRF Dictionary for Maintenance, Case Processing, and Submissions. ## FDA eMDR Mapping The following sections outline the XML sections and the sources for populated values. ### Header Vault populates the following Header data elements:
Data Element Name Populated Value
C.1.2 - Date of Creation If the Case is Approved or Closed, the Approval Date. If Approval Date is blank, the date of report generation or transmission with a system warning. Otherwise, the date and time of report generation, calculated with full precision down to the second.
N.1.2 - Batch Number The E2B Message ID on the Transmission.
N.1.5 - Date of Message Creation The date and time when the report was generated, calculated with full precision down to the second.
N.2.r.1 - Message Identifier The UID on the Case.
N.2.r.2 - Message Sender Identifier The Origin ID on the Transmission Profile associated with the Transmission.
N.2.r.3 - Message Receiver Identifier The Destination ID on the Transmission Profile associated with the Transmission.
N.2.r.4 - Message Date If the Case is Approved or Closed, the Approval Date. Otherwise, the date and time of report generation, calculated with full precision down to the second.
### Section A: Patient Information Vault populates the following Section A data elements:
Data Element Name Populated Value
A1 - Patient Identifier From the Case Patient, Vault populates the Patient Initials / ID. If blank, Vault populates the MRN - Investigation.
A2 - Date of Birth/Age at time of Event From the Case Patient, Vault populates the Date of Birth and the Age (value and unit). If Age (value and unit) is blank, Vault populates the Age (normalized).
A3A - Sex Vault populates a code based on the Sex of the Case Patient:
  • For Male, Vault populates C20197.
  • For Female, Vault populates C16576.
Depending on your Admin's configuration, the Sex field may be labeled Gender.
A3B - Gender Vault populates a code based on the Gender of the Case Patient:
  • For Cisgender Man, Vault populates C46109.
  • For Cisgender Woman, Vault populates C46110.
  • For Transgender man/FtM, Vault populates C46121.
  • For Transgender woman/MtF, Vault populates C46120.
  • For Other Gender Identity, Vault populates C154420.
A4 - Weight From the Case Patient, Vault populates the Weight (value and unit). If blank, Vault populates the Weight (normalized).
A5 - Ethnicity Vault populates a code based on the Ethnicity of the Case Patient:
  • For Hispanic or Latino, Vault populates C17459.
  • For Not Hispanic or Latino, Vault populates C41222.
  • For any Reason Omitted, Vault populates NI.
A6 - Race Vault populates a code based on the Race of the Case Patient:
  • For Black or African American, Vault populates C16352.
  • For American Indian or Alaska Native, Vault populates C41259.
  • For Asian, Vault populates C41260.
  • For Native Hawaiian or Other Pacific Islander, Vault populates C41219.
  • For White, Vault populates C41261.
### Section B: Adverse Event or Product Problem Vault populates the following Section B data elements:
Data Element Name Populated Value
B1 - Type of Report Based on the report type, Vault populates a code:
  • If the Device Report Type includes Malfunction or Product Problem and Malfunction Only is Yes, Vault populates C53054.
  • If the Device Report Type includes Malfunction or Product Problem and Malfunction Only is not Yes, Vault populates C53054 and C41331.
  • If the Device Report Type does not include Malfunction or Product Problem, Vault populates C41331.
B2 - Outcomes attributed to adverse event Vault populates a code for each Overall Case Seriousness value in the Details section of the Case:
  • For Life Threatening, Vault populates C41337.
  • For Caused / prolonged hospitalisation, Vault populates C25179.
  • For Disabling / incapacitating, Vault populates C21007.
  • For Congenital anomaly / birth defect, Vault populates C2849.
  • For Required Intervention to Prevent Permanent Impairment/Damage (Devices), Vault populates C52668.
  • For Other medically important condition, Vault populates C17649.
  • For Results in death, Vault populates C28554.
B2 - Date of Death From the Case Patient, Vault populates the Date of Death in YYYYMMDD format.
B3 - Date of Event The earliest Onset Date from any Case Adverse Event in YYYYMMDD format.
B4 - Date of this Report The date of report generation in YYYYMMDD format.
B5 - Describe Event or Problem Vault populates the Narrative text and then the Company Comments.
B6 - Relevant tests/laboratory data For each Case Test Result, sorted alphabetically and from earliest to latest, Vault populates:
  • Test Name (LLT) and Test Name (Reported)
  • Result (Unit) or Result (Unit) Text
  • Result (Code) or Result (qualifier) and Result and Result (Unit)
  • Test Name (LLT) and Test Name (Reported), Result
  • Test Date
If the adverse event resulted in death, from each Case Cause of Death record, Vault populates:
  • Reported Causes of Death: Cause (MedDRA) or Cause (Reported)
  • Autopsy-Determined Cause of Death: Cause (MedDRA) or Cause (Reported)
B7 - Other relevant history, including preexisting medical conditions For each Case Medical History record Vault populates:
  • Disease / Surgical Procedure (MedDRA)
  • Start Date or --- to End Date or --- or Continuing
  • Comments

After listing each medical history line item, Vault populates any text in the Medical History Text field on the Case.
### Section C: Suspect Products Vault populates the following Section C data elements:
Data Element Name Populated Value
C - Drug Sequence Number Vault populates a number between 1 and 20 to indicate its sequence in the exported suspect products.
C - Drug Type Vault populates a code based on the Registration Type on the Product Registration for the Case Product:
  • For New Drug Application (NDA), Vault populates NDA.
  • For Abbreviated New Drug Application (ANDA), Vault populates ANDA.
C - Approval Number From the Product Registration for the Case Product, if the Registration Type is not Investigational New Drug (IND), Vault populates the Registration Number.
C - If IND/PreANDA, Give Protocol # From the Product Registration for the Case Product, if the Registration Type is Investigational New Drug (IND), Vault populates the Registration Number.
C1 - Name and Strength Vault populates the Product (Reported). If blank, Vault populates the Product (Coded).
C1 - Manufacturer/Compounder Vault populates the Manufacturer on the Product. If blank, Vault populates the Name on the associated Organization.
C1 - NDC # or Unique ID Vault populates the National Drug Code on the Product Registration.
C1 - Lot # Vault populates the Batch/Lot Number on the Case Product Dosage.
C3 - Dose From the earliest-created Case Product Dosage, Vault populates the Dose value and unit.
C3 - Frequency From the earliest-created Case Product Dosage, Vault populates the Frequency value and unit.
C3 - Route Used From the earliest-created Case Product Dosage, Vault populates the code corresponding to the Patient RoA.
C4 - Treatment Dates/Therapy Dates - Start Date From the earliest-created Case Product Dosage, Vault populates the First Admin Date.
C4 - Treatment Dates/Therapy Dates - Stop Date From the earliest-created Case Product Dosage, Vault populates the Last Admin Date.
C5 - Diagnosis Use For Based on your Admin's configuration, from the Case Product Indication, Vault populates the Name (MedDRA) or the Indication (Reported). If Name (MedDRA) is blank, Vault populates the Name (Reported). Vault comma-separates multiple values and sorts them from earliest to latest.
C6 - Product Type Vault populates true or false for each of the following:
  • Whether the FDA Product Type on FDA Product Registrations for the Case Product includes OTC, Compounded, Generic, or Biosimilar
  • Whether the associated Transmission Profile is CDER IND Exempt
  • Whether the International Birthdate on the Product is a date earlier than 1938
C7 - Expiration Date The Expiration Date on the Case Product.
C8 - Event Abated After Use Stopped or Dose Reduced? Vault uses the following fields to calculate whether a dechallenge test occurred and populates true, false, or N/A for each combination:
  • Action Taken on the primary Case Product
  • Outcome on the primary Case Adverse Event
C9 - Event Reappeared After Reintroduction Vault uses the Reaction Recurrence value on the primary Case Assessment to determine whether a rechallenge test occurred and populates a value as follows:
  • Vault populates true if the Reaction Recurrence is yes – yes (rechallenge was done, reaction recurred).
  • Vault populates false if the Reaction Recurrence is yes - no (rechallenge was done, reaction did not recur).
  • Vault populates N/A if the Reaction Recurrence is any of the following:
    • yes - unk (rechallenge was done, outcome unknown)
    • no - n/a (no rechallenge was done, recurrence is not applicable)
    • blank
### Section D: Suspect Medical Device Vault populates the following Section D data elements:
Data Element Name Populated Value
D1 - Brand Name Based on the Device-type Case Product on the Transmission, Vault populates either the Product (Reported) or the Product (Coded). When both exist on the Transmission, Vault populates a value based on your Admin's configuration.
D2 - Type of device Based on the Device-type Case Product on the Transmission, Vault populates the Product Code on the related Product Registration.
D2 - Device Type Name If Vault populates a value in the D2 data element, Vault populates the Generic Name on the associated Product.
D3 - Manufacturer Name Based on the Device-type Case Product on the Transmission, Vault populates the Name of the Organization in the Manufacturer field on the associated Product Family. Otherwise, Vault populates the Organization on the associated Product Family.
D3 - Manufacturer Street 1 Based on the Device-type Case Product on the Transmission, Vault populates the Street of the Organization in the Manufacturer field on the associated Product Family. Otherwise, Vault populates the Street on the associated Organization.
D3 - Manufacturer City Based on the Device-type Case Product on the Transmission, Vault populates the City of the Organization in the Manufacturer field on the associated Product Family. Otherwise, Vault populates the City on the associated Organization.
D3 - Manufacturer State Based on the Device-type Case Product on the Transmission, Vault populates the State of the Organization in the Manufacturer field on the associated Product Family. Otherwise, Vault populates the State on the associated Organization.
D3 - Manufacturer Postal Code Based on the Device-type Case Product on the Transmission, Vault populates the Postal Code of the Organization in the Manufacturer field on the associated Product Family. Otherwise, Vault populates the Postal Code on the associated Organization.
D3 - Manufacturer Country Based on the Device-type Case Product on the Transmission, Vault populates the Country of the Organization in the Manufacturer field on the associated Product Family. Otherwise, Vault populates the Country on the associated Organization.
D3 - Manufacturer Email Address Based on the Device-type Case Product on the Transmission, Vault populates the Email Address of the Organization in the Manufacturer field on the associated Product Family. Otherwise, Vault populates the Email Address on the associated Organization. Vault prepends the value with mailto:.
D4 - Model Number The Model Number on the Device-type Case Product.
D4 - Lot Number The Lot Number on the Device-type Case Product.
D4 - Catalog Number The Catalog Number on the Device-type Case Product.
D4 - Expiration Date The Expiration Date on the Device-type Case Product.
D4 - Serial Number The Serial Number on the Device-type Case Product.
D4 - Unique Identifier The Unique Identifier on the Device-type Case Product.
D5 - Operator of device Vault populates a code based on the Operator of Device of the Case Product on the Transmission:
  • For Health Professional, Vault populates C53287.
  • For Lay Person, Vault populates C16960.
  • For Other, Vault populates C17649.
D5 - Other Operator If Operator of Device is Other, Vault populates the Operator of Device (Other) value.
D6A - Implanted Date Based on the Device-type Case Product on the Transmission, Vault populates the Date Implanted.
D6B - Explanted Date Based on the Device-type Case Product on the Transmission, Vault populates the Date Explanted.
D7A - Is this a single-use device that was reprocessed and reused on a patient? If Yes exists on both the Reprocessed/Reused and Single Use fields on the Device-type Case Product, Vault populates true. Otherwise, Vault populates false.
D7B - Reprocessor Info If Vault populates true in the D7A data element, Vault populates the Reprocessor value on the Device-type Case Product on the Transmission.
D8 - Was this device serviced by a third party? Vault populates a value based on the Third-party servicer for device? of the Case Product on the Transmission:
  • For Yes, Vault populates true.
  • For No, Vault populates false.
  • For Unknown, Vault populates AKSU.
D9 - Device available for evaluation? Vault populates true or false based on the Device Available value of the Case Product on the Transmission.
D9 - Date returned to manufacturer Vault populates the Returned Date on the Device-type Case Product on the Transmission in YYYYMMDD format.
D10 - Concomitant medical products For each Case Product with a Drug Role of Concomitant, Vault populates the Product (Reported). If blank, Vault populates the Product (Coded).
D10 - Therapy dates For each Case Product with a Drug Role of Concomitant, Vault populates values from the following fields when available:
  • Product or Product (Reported)
  • First Admin Date
  • Last Admin Date
### Section E: Initial Reporter Vault populates the following Section E data elements:
Data Element Name Populated Value
E1 - Reporter First Name The First Name on the primary Reporter-type Case Contact.
E1 - Reporter Middle Name The Middle Name on the primary Reporter-type Case Contact.
E1 - Reporter Last Name The Last Name on the primary Reporter-type Case Contact.
E1 - Reporter Title The Title on the primary Reporter-type Case Contact.
E1 - Facility Name The Organization on the primary Reporter-type Case Contact.
E1 - Reporter Address Line 1 The Street on the primary Reporter-type Case Contact.
E1 - Reporter Address Line 2 The Street Line 2 on the primary Reporter-type Case Contact.
E1 - Reporter City The City on the primary Reporter-type Case Contact.
E1 - Reporter State The State on the primary Reporter-type Case Contact.
E1 - Reporter Postal Code The Postal Code on the primary Reporter-type Case Contact.
E1 - Reporter Country The Country on the primary Reporter-type Case Contact.
E1 - Reporter Email Address The Email Address on the primary Reporter-type Case Contact. Vault prepends the value with mailto:.
E1 - Reporter Phone Number The Telephone on the primary Reporter-type Case Contact.
E1 - Reporter Fax Number The Fax on the primary Reporter-type Case Contact.
E3 - Occupation Vault populates a code based on the Qualification on the primary Reporter-type Case Contact as follows:
  • For Biomedical engineer, Vault populates C51960.
  • For Dentist, Vault populates C52654.
  • For Nurse, Vault populates C20821.
  • For Consumer/non-Healthcare Professional, Vault populates C134833.
  • For Other Health Care Professional, Vault populates C53289.
  • For Pharmacist, Vault populates C51840.
  • For Physician, Vault populates C25741.
  • For Physician Assistant, Vault populates C53423.
  • For Third Party Servicer, Vault populates C85488.
  • For Risk Manager, Vault populates C53448.
  • For Healthcare professional, Vault populates C53289.
  • If Qualification is not a healthcare professional, Vault populates C134833.
E4 - Initial reporter also sent report to FDA Based on the Sent to FDA? value on the primary Reporter-type Case Contact, Vault populates true or false.
### Section F: For Use by User Facility/Importer (Devices Only) Vault does not populate section F. ### Section G: All Manufacturers Vault populates the following Section G data elements:
Data Element Name Populated Value
G1 - Site Name The First Name, Middle Name, and Last Name on the Sender User on the associated Transmission.
G1 - Street Address Line The Street Address on the Sender User on the associated Transmission.
G1 - City The City on the Sender User on the associated Transmission.
G1 - State The State on the Sender User on the associated Transmission.
G1 - Postal Code The Postal Code on the Sender User on the associated Transmission.
G1 - Country The Country on the Sender User on the associated Transmission.
G1 - Email Address The Email Address on the Sender User on the associated Transmission.
G1 - Fax Number The Fax on the Sender User on the associated Transmission.
G2 - Contact Report Source Vault populates a code based on the Report Type as follows:
  • For Literature (Spontaneous), Vault populates C48471.
  • For Literature (Study) or Study, Vault populates C15206.
For other Report Types, Vaut populates a code based on the primary Reporter-type Case Contact as follows:
  • If Country is not United States, Vault populates C25512.
  • If Country is United States, Vault populates a code based on the FDA 3500A Report Source or Qualification as follows:
    • For Company Representative, Vault populates C51968.
    • For Distributer, Vault populates C48289.
    • For Other, Vault populates C17649.
    • For a non-healthcare professional Qualification, Vault populates C53568.
    • For a healthcare professional Qualification, Vault populates C53287.
G2 - Contact Report Source - Other Text If the Country of the primary Reporter-type Case Contact is United States and has Other as the FDA 3500A Report Source, Vault populates the Other Source Text.
G3 - Date received by manufacturer For an initial Case, Vault populates the New Info Date. If blank, Vault populates the Initial Receipt Date.

For a follow-up Case, Vault populates the New Info Date.
G4 - PMA/510k (or) BLA # If Registration Type on the associated Product Registration is BLA, PMA, or 510k, Vault maps the Registration Number to a maximum of 12 characters.
G4 - Combination product If any Case Product is a device constituent of a Combination Product, Vault populates C54696.
G6 - Type of report For an initial Case, Vault populates C53620. For a follow-up Case, Vault populates C53579.

Vault populates additional codes based on the FDA Report Type on the Transmission as follows:

  • For 5-day, Vault populates C53573.
  • For 7-day, Vault populates C53574.
  • For 15-day, Vault populates C53576.
  • For 30-day, Vault populates C53577.
  • For Periodic, Vault populates C53578.

If FDA Report Type is blank, Vault populates codes as follows:

  • When the Device Report Type on the Case contains Public Health Risk, Vault populates C53573.
  • When the Case is tagged as a SUSAR and the Seriousness field on the primary Case Adverse Event contains Results in Death or Life-Threatening, Vault populates C53574.
  • Vault populates C53576 when:
    • For an initial study Case, the Case has a SUSAR tag and does not qualify for the 7-day option (for example, the Seriousness on the primary Case Adverse Event is not Results in Death or Life-Threatening).
    • For a postmarket spontaneous Case, whether initial or follow-up, the Seriousness on the primary Case Adverse Event is populated and the Case Expectedness is No.
  • For device malfunction-only reports, Vault populates C53577.
  • In all other instances, Vault populates C53578.
G6 - Follow up number For a follow-up Case, Vault populates the Follow-up Number on the Transmission.
G7 - Adverse Event Terms The Event (MedDRA) or Event (Reported) - English on the primary Case Adverse Event.
G8 - MFR Report # The FDA Manufacturer Report Number on the Case Product on the Transmission. If blank, and only one Case Product on the Case related to the Transmission includes an FDA Manufacturer Report Number, Vault populates that value. Otherwise, Vault populates the UID on the Case.
### Section H: Device Manufacturers Only Vault populates Section H only for _Cases_ concerning a _Combination Product_ with a _Device_-type _Product Constituent_.
Data Element Name Populated Value
H1 - Type of Reportable Event Vault exports codes as follows:
  • If the Seriousness of any Case Adverse Event includes Results in Death, Vault populates C28554.
  • If the Device Report Type on the Case includes Serious Injury, Vault populates C53569.
  • If the Malfunction on the primary Device-type Case Product or the Device Report Type on the Case includes Malfunction, Vault populates C25745.
H2 - If Follow-up, What Type? Vault exports codes based on the Device Follow-Up Type on the Case as follows:
  • For Correction, Vault populates C53585.
  • For Additional Information, Vault populates C53586.
  • For Response to FDA Request, Vault populates C53587.
  • For Device Evaluation, Vault populates C53588.
H3 - Device Evaluated by MFR? If the Device Evaluated on the Case Product contains Yes, Vault populates true. Otherwise, Vault populates false.
H4 - Device Manufacture Date The Manufacture Date on the Case Product.
H5 - Labeled for Single Use? If the Single Use on the Device-type Case Product contains Yes, Vault populates true. Otherwise, Vault populates false.
H6 - Adverse Event Problem Based on the Device Type Code and Device Code on the Device-type Case Product, Vault populates the level 1, 2, or 3 FDA or IMDRF codes. To use IMDRF codes, your Admin must enable the IMDRF Dictionary for Maintenance, Case Processing, and Submissions.
H7 - If Remedial Action Initiated, Check Type Vault populates codes based on the Remedial Action primary Device-type Case Product as follows:
  • For Inspection, Vault populates C53604.
  • For Modification/Adjustment, Vault populates C53606.
  • For Notification, Vault populates C25297.
  • For Patient Monitoring, Vault populates C53607.
  • For Relabeling, Vault populates C53608.
  • For Recall, Vault populates C53609.
  • For Replace, Vault populates C53610.
  • For Repair, Vault populates C53611.
  • For Other, Vault populates C17649.
When the Remedial Action is Other, Vault exports the Remedial Action Other text on the Case.
H8 - Usage of Device Vault populates codes based on the Device Usage Type primary Device-type Case Product as follows:
  • For Initial Use, Vault populates C53612.
  • For Reuse, Vault populates C53613.
  • For Unknown, Vault populates C17998.
H9 - If Action Reported to FDA Under 21 USC 360i(f), List Correction/Removal Reporting Number The Correction/Removal Reporting Number on the Device-type Case Product.
H10 - Additional Manufacturer Narrative The Additional Manufacturer Narrative value on the associated Device-type Case Product. Text that exceeds the field character limit appears in the overflow pages under the heading H.10 Additional Manufacturer Narrative.
### Attachments Vault attaches documents to FDA eMDR XML files using the same criteria as for E2B files. Vault excludes attachments as follows: * For files that exceed 15 MB, Vault excludes attachment contents from generated FDA eMDR files. * If the _Attachment Type_ of the document does not match a _Destination Specific Attachment Type_ on the _Transmission Profile_ or the _Retransmit_ value is _No_, Vault excludes the document content from the XML.