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:
- Use Case Name
- 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.
- Reason for Providing this Use Case
State the reason you think that this use case is important for us to consider
- 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.
- Specific Business Rules to address (optional)
List any business or validation rules that may be applicable to this story.
- Other Considerations
Identify any considerations for the use case that may need to be addressed during design or implementation.