Here’s this week’s example of an Additional Information Request (AI Request):
FDA Additional Information Request – Example #7: Missing Software Unit Testing
FDA is unable to locate the unit testing described in your submission.
FDA acknowledges that you note unit testing was completed and reference test cases in your documentation; however, these test cases do not appear to be unit tests.
Software units, as described in IEC 62304: “Medical Device Software – Software life cycle processes”, are the lowest level of software item that is not further decomposed. As outlined in the FDA Guidance document, titled “General Principles of Software Validation”, unit level testing ensures functionality not visible at the system level is examined and ensures that quality software units are furnished for integration into the finished product.
The testing provided does not appear to be of software units but instead appear to be system or integration testing of the software items in your software. Please provide unit testing for your software units.
In this example, the FDA’s Additional Information Request focuses specifically on the area of Software Unit Testing.
The medical device company failed to provide the FDA with testing of the individual “units” of the software. Units was the abstract name chosen by the FDA for functions/methods/procedures/etc. – the smallest software item that can’t be further decomposed. In this case, the medical device company was defining a “unit” as the software requirements testing of a microcontroller, which is not acceptable by either the FDA or the EU.
The FDA is requesting the medical device company provide unit testing of correctly leveled software units – function, procedures, and methods.
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.