Here’s this week’s example of an Additional Information Request (AI Request):
FDA Additional Information Request – Example #5: Missing Observed Results in Test Logs
You provided software testing as part of Verification and Validation section of your submission. However, FDA has concerns regarding the documentation that was provided.
Please note that adequate software testing documentation is important to demonstrate with objective evidence that software development output meets its input requirement, and that the software conforms with user needs and intended uses of the device.
Adequate software testing is also important because inadequately validated software could result in adverse health effects for the patient.
For all software module test reports, you did not describe observed test results to support your determination that the test cases passed. Therefore, as recommended in the “Software Testing as Part of Verification and Validation” section of FDA’s guidance document “Content of Premarket Submissions for Device Software Functions”, please update your test reports to include the observed test results.
In this example, the FDA’s Additional Information Request focuses on the area of Software Testing.
The medical device company failed to provide the FDA with adequate testing documentation, especially related to capturing contemporaneous objective evidence. There needs to be both expected results and observed (actual) results documented, which can then lead to the determination of the individual test step passing or failing.
CriTech has found the FDA welcomes handwritten filled in test logs signed by the tester with the corresponding date/time as proof of the contemporaneous recording. Some companies attempt to skirt the handwritten test logs by capturing the data in an electronic spreadsheet after the fact, which can be difficult to prove what was actually observed during the test execution. As one FDA reviewer told me – “I welcome the slightly coffee stained and crumpled paper test results because I know they are real.”
The FDA is requesting the medical device company update their test reports (test logs) to include observed results, which will likely trigger the need for re-execution of all testing in order to properly capture the observed results.
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.
