Here’s this week’s example of an Additional Information Request (AI Request):
FDA Additional Information Request – Example #11: Incomplete Software Design Documentation
You provided a software design specification document in your submission; however, it does not demonstrate how the requirements were implemented to an appropriate level of detail.
For example, IEC 62304 recommends that the software detailed design subdivide the software until it is represented by software units, and it does not appear that the document you have provided describes the software units of your software.
Additionally, the software design document appears to be incomplete and does not adequately capture all of your software design as described in your labeling, such as some critical software functionality.
Multiple software functions described in other parts of your documentation (such as cybersecurity and labeling) but are not traceable back to your software documentation and testing.
None of these design details are described in your design specification document.
This information is important to assess the adequacy of the implementation of the software requirements in terms of intended use, functionality, safety, and performance, which is important to determine the testing needed to mitigate relevant software-related risks. Adequate testing and risk mitigation are important because software with unmitigated risks could result in adverse health effects for the patient.
Therefore, as recommended in the “Software Design Specification” section of the FDA guidance document “Content of Premarket Submissions for Device Software Functions”, please update your software design specification document to address the concerns cited above.
In this example, the FDA’s Additional Information Request focuses on the lack of detail in the software design documentation. In particular, the FDA couldn’t find what typically would be found in Software Detailed Design documentation: descriptions of how a unit is to be implemented.
In addition, the FDA is looking for traceability of the software requirements to the units in which those requirements are implemented, as well as related testing.
The FDA is also looking for detailed design documentation which allows the assessment of sufficiency of testing to demonstrate the safe implementation of the software requirements.
The FDA is requesting the medical device company update the software design specification document to address the concerns found.
Please follow us to see more examples of AI Requests – a new one is released every week.
Should you receive an Additional Information Request from the FDA, CriTech is here to help. Please give us a call to discuss and we’ll help you craft what you need to do going forward.