Here’s this week’s example of an Additional Information Request (AI Request):
FDA Additional Information Request – Example #13: Incomplete Software Requirements Documentation
You provided Software Requirements Specification (SRS) documentation in your submission.
However, it is not adequate because it does not include sufficient details on the functions that the software will perform, user interactions, or all ranges, limits, defaults, and specific values that the software will accept.
For example, a critical mode is not described, limits and defaults are not described, and adjustments and methods are not described. This information is important to understand how your device is intended to operate, understand the functionality of your software, and 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, please revise the SRS to include the missing information and provide this updated information for our review as recommended in the “Software Requirements Specifications” section of the FDA guidance document “Content of Premarket Submissions for Device Software Functions”.
In this week’s example, the Additional Information Request focuses on the missing information in the software requirements documentation. In particular, the software requirements do not include sufficient details on the functions that the software will perform, user interactions, ranges, limits, defaults, and specific values that the software will accept.
A critical mode of operation for the device is not described in the software requirements, including limits, defaults, adjustments, and methods. The software requirements need to include descriptions on how the device is intended to operate, the overall functionality of the software, and determination of testing needed to ensure mitigation software-related risks.
The FDA is requesting the medical device company revise their Software Requirements Specification (SRS) to include the missing information. Making changes to the requirements will likely lead to a need to update design documentation, as well as the potential for source code changes and even a complete update and re-execution of testing.
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.