FDA Guidance on Software Changes

On October 25, 2017 the FDA released its guidance on "Deciding When to Submit a 510(k) for a Software Change to an Existing Device". A draft of this guidance was released in August 2016 and I commented on that draft here. The scope of what was changed is not easy to discern, especially since the draft is no longer directly available and the URL for the final guidance is the same as that for the previous draft. No doubt there are many people who have a copy of the draft and the Wayback Machine might also be explored. But such a comparison might be moot anyway with respect to what the FDA is now telling us it expects manufacturers to do when changing software, but doesn't quite require them to do because guidance documents can't set requirements, except when they do. This software guidance is a special case of the more general guidance on "Deciding When to Submit a 510(k) for a Change to an Existing Device"   which was also released on October 25th.   For this discussion I will focus on the decision making flow chart of the software guidance, which has been changed from the draft, at least in its more streamlined appearance. The first question in the flow chart is whether the change is for cybersecurity only without any other impact on the performance of the software, and for embedded software the performance of the device. If the answer is "yes" then the change can be made without a new 510(k), and documented accordingly. If the answer is "no" then the next set of questi...
Source: Medical Connectivity Consulting - Category: Information Technology Authors: Tags: Standards & Regulatory Source Type: blogs