Here’s this week’s example of an Additional Information Request (AI Request):
FDA Additional Information Request – Example #17: Lack of Documenting the Final Version Number of the Software and Firmware
The final version number of your software/firmware was not provided in your submission.
The version number is needed to identify the current software version utilized in your device to ensure that the documentation provided with your premarket submission corresponds to the final version. This is important to understand any differences between the tested software version and final release version of the software. Differences between the tested software version and release software version could impact the device’s safety and effectiveness profile and result in software that is not safe and effective for its intended use, resulting in adverse health effects for the patient.
Therefore, as recommended in the “Software Version History” section of FDA’s guidance document “Content of Premarket Submissions for Device Software Functions”, please provide the final version number of your software and each of your software components.
In this example, the FDA’s Additional Information Request identifies an omission in the medical device company’s submission: the lack of documenting the final version number of the software and firmware.
As the FDA points out, the correct and proper control of a software versioning process is critical for the overall safety and efficacy of the medical device. Key in this regard is knowing which versions of what software were used to make an overall software version release for testing and tracing the resulting anomalies back into source code, design, and requirements documentation.
The FDA is requesting the medical device company provide the final version number for the software release, as well as the specific versions of each of the software components. The FDA will use this information to ensure consistency across the various documents as well as testing performed.
If testing for a given component refers to an earlier release of a component version, a regression analysis needs to be performed to document the continued adequacy of the previous executed testing versus the latest release of the software.