Here’s this week’s example of an Additional Information Request (AI Request):
FDA Additional Information Request – Example #10: Missing Testing of All Device Functionality
It does not appear that all functionality of your software was tested.
For example, your labeling notes that various functionality is critical to the device operation. FDA could not find any level of testing (unit, integration, system) to demonstrate that this software function was tested.
Additionally, your labeling describes a special critical mode. FDA was unable to find any level of testing to demonstrate that this mode functions as expected and as described in your labeling.
Finally, your labeling describes an ability to enter patient information and to determine some patient characteristics. This is not described or tested in your software documentation.
These are three examples of 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.
Please provide software verification and validation at the unit, integration, and testing levels to demonstrate that all aspects/functions of your software have been tested.
In this example, the FDA’s Additional Information Request focuses on the lack of completeness in the software system testing (requirement-based).
The FDA found numerous occurrences of incomplete testing of certain device functionality, pointing out no software unit, software integration, nor software system testing was provided in the submission.
The medical device company must provide verification at the software unit, software integration, and software system levels which adequately demonstrate that all aspects/functions of the software have been properly implemented and tested.
The lack of traceability between the software documentation and testing is a challenge the medical device company needs to address. A complete requirements traceability matrix (RTM) is a key mechanism to document the completeness of the implementation of the software’s requirements – tracing requirements through design, coding, and testing. FDA recognizes a complete RTM as a sign of software maturity within the medical device company.
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.