Request for Use Cases

The UDI Team is collecting stories addressing common concern/questions with UDI implementation. Please use the template below to send us the Use Cases that are the most important to you to the e-mail address: CDRHUDI@fda.hhs.gov.

We suggest the following format for each use case:

1. Use Case Name
2. Description of Use case
   Provide a brief story that thoroughly describes a situation involving potential positive or negative affects on data quality, timeliness of data entry/access, adverse event reporting, recalls or any other area of concern that we should consider during UDI implementation.
3. Reason for Providing this Use Case
   State the reason you think that this use case is important for us to consider
4. Specific UDI Issues
   Provide a bulleted list with brief descriptions of the specific issues that are addressed in this use case. Examples include: allocation rules, system requirements, use of data standards.
5. Specific Business Rules to address (optional)
   List any business or validation rules that may be applicable to this story.
6. Other Considerations
   Identify any considerations for the use case that may need to be addressed during design or implementation.