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.

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). Note: Your Admin can configure your Vault to export the Product (Coded) value by default.
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). Note: Your Admin can configure your Vault to export the Product (Coded) value by default.
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.