# FDA Report Formats Vault supports compliant generation and submission of multiple FDA-specific formats, including: * FDA MedWatch 3500A (September 2025 Version) * FDA MedWatch 3500A (August 2024 Version) * FDA MedWatch 3500A (October 2015 Version) * FDA eMDR * FDA FAERS E2B(R3) * FDA VAERS E2B(R3) * FDA E2B(R2)

Note: Vault generates only the FDA MedWatch 3500A form version configured by your Admin.

## FDA MedWatch 3500A Data Mapping Considerations {#data-mapping} The following list describes how Vault handles certain data while generating FDA MedWatch 3500A forms: * For events, diagnoses, indications, test names, and medical conditions, Vault Safety always populates the MedDRA Lowest Level Term (LLT) when there is a coded value available. If there is no MedDRA term available, the reported term is used.

Note: Your Admin can configure your Vault to populate the MedDRA Preferred Term (PT) for adverse events instead of the LLT.

* Dates are populated using the format `dd-mmm-yyyy`. Blank dates are populated as dashes (-\-\-). * Certain fields may be masked, depending on the blinding settings on the _Case_ or masking settings on the _Distribution_. * Depending on your Admin's configuration, open-label _Products_ within blinded _Studies_ may be unmasked. * When populating section C, Vault exports up to 20 suspect _Case Products_ and 20 concomitant _Case Products_ based on _Rank_. When _Rank_ is blank, Vault uses the following priority order: 1. The earliest-created _Company Products_ 2. The earliest-created _External Products_

Note: For FDA eMDR files, Vault exports up to 20 Case Products.

* If a _Case_ includes a _Company Product_ with an unknown formulation, Vault determines the form sections to map to based on the _Product Registrations_ within the _Product Family_: * If all _Registrations_ have a _Registered As_ value of _Drug_, Vault considers the unknown formulation _Product_ a drug and maps to section C * If all _Registrations_ have a _Registered As_ value of _Device_, Vault considers the unknown formulation _Product_ a device and maps to section D * If _Registrations_ have differing _Registered As_ values, Vault maps to section C * Vault maps _Case Products_ with an eligible _Drug Role_ to form sections as follows: * **C. Suspect Products**: * Company _Products_ if the _Product Type_ is not _Device_ or _OTC Device_ * _Study Products_ if the _Product Type_ is not _Device_ * _External Products_ if the _Product Type_ is not _Device_ * **D. Suspect Medical Device** and **H. Device Manufacturers Only**: * Company _Products_ if the _Product Type_ is _Device_ or _OTC Device_ * _Study Products_ if the _Product Type_ is _Device_ * _External Products_ if the _Product Type_ is _Device_ * When generating the August 2024 version of the form, for _Cases_ with _Combination Products_ that have multiple device constituents: * Vault populates the device constituent _Case Product_ with the highest rank in section D and populates section D information for all other device constituents in the overflow pages. If _Case Products_ are not ranked, Vault populates the earliest-created device constituent _Case Product_ in section D. * Vault considers all device constituents when populating section H.