# FDA Report Formats
Vault supports compliant generation and submission of multiple FDA-specific formats, including:
* FDA MedWatch 3500A (August 2024 Version)
* FDA MedWatch 3500A (October 2015 Version)
* FDA eMDR
* FDA E2B(R3)
* FDA VAERS E2B(R3)
* FDA E2B(R2)
## FDA MedWatch 3500A Data Mapping Considerations {#data-mapping}
When generating FDA MedWatch 3500A forms, Vault populates certain data as follows:
* For coded events, diagnoses, indications, test names, and medical conditions, Vault populates the MedDRA Lowest Level Term (LLT). Otherwise, Vault populates the reported term.
Note: Your Admin can configure your Vault to populate the MedDRA Preferred Term (PT), instead of the LLT, for adverse events.
* Dates appear in `dd-mmm-yyyy` format. Blank dates appear 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_
### August 2024 Version Device Data Mapping {#device-products}
When generating the August 2024 version of the form:
* If the _Case Product_ on the _Transmission_ is a device, Vault exports data for that product to sections D and H. If the _Case_ includes any other devices, Vault exports each to separate FDA MedWatch 3500A forms.
* For section G, if the _Case_ is for a clinical trial _Study_, Vault populates fields G.4 and G.5 using the following priority:
1. The Investigational New Drug (IND) _Study Registrations_ with the FDA. If multiple IND registrations exist, Vault populates information from the earliest-created _Study Registration_.
2. The _Product Registration_ related to the _Case Product_ on the _Transmission_.
* If the _Case Product_ on the _Transmission_ is blank:
* Vault populates the device _Case Product_ with the highest rank in section D, and populates section D information for all other devices in the overflow pages. If _Case Products_ are not ranked, Vault populates the earliest-created device _Case Product_ in section D.
* 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.