Here’s this week’s example of an Additional Information Request (AI Request):
FDA Additional Information Request – Example #4: Missing Software Version History
You provided some software version history documentation in this submission; however, it does not document the history of software versions generated during product development from the initial version to the final release version. The documentation that was provided in your submission starts at the version submitted for FDA’s review, which is not a complete version history. The version history provided also lacks the version histories of the individual software modules/sub-systems/components.
Software modules have their own versioning and version history which are not provided in your documentation. A complete software version history tabulating the changes to the software during the development cycle (including date, version number, and a brief description of the changes in the version relative to the previous version) 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 software version history documentation that identifies the history of the software versions that were generated during the course of product development, along with (a) any differences between the tested and release software versions and (b) an assessment of the potential effect of these differences on the device’s safety and effectiveness.
In this example, the FDA’s Additional Information Request focuses on the area of Software Version Control.
The medical device company failed to provide the FDA with a coherent set of software versions created and tested during the medical device’s product development life cycle.
The FDA is requesting the medical device company provide the recommended “Software Version History.” Often, this is a challenging request for the company to provide if they have not kept track of the software versions released for testing (as well as the resulting anomalies generated by testing relevant to each version).
As with most AI Request items, the FDA justifies the regulatory requirements, then asks for the relevant documentation required by the regulatory requirements.
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 here to help. Please give us a call to discuss and we’ll help you craft what you need to do going forward.
