Software item classification and Detailed Design

I always thought the DRAFT guidances did a good job explaining that they reflect the current thinking (and training delivered to) the current set of agency employees. We outside of the agency simply can’t use them as “get out of non-compliance” trump cards. It is a little like reading tea leaves, but that’s part of the relationship.

I don’t precisely know how the agency is going to view your communication with them, but they are going to expect a relatively straightforward risk analysis that aligns with your intended use. Where you (in this thread) have been offering discussion around “some is Class A, it won’t have as much documentation as the stuff that is Class B” is essentially immaterial to agency discussions… it those areas are really class A, they simply won’t be showing up (with details) in an accurately established risk management file, so there would not need to be those documents in your communication with the FDA. Picture sending someone into the wilderness with only a list of risks (the “class B” items) you think they will encounter… doesn’t it seem reasonable to also include on such a list that the other things they encounter that you don’t consider to be risk? (the “class A” items)

What follows is not meant to be cruel:This situation reminds me of someone trying to see how high the bar is set and that person is trying to jump just high enough to clear the bar. This has always been a bad strategy when dealing with regulators. The guidance(s) are about how much of the work a developer did should be submitted for the reviewers to adequately their job…. not about how much work the developer needs to do. Any slight change and there is a risk of not clearing the bar on the first attempt.

There is an additional twist: there is no guarantee that any particular FDA reviewer will have lots of experience and/or familiarity with your documents (or even product). In past years I worked on a submission that had a relative “rookie” who was very professional and by no means ill-informed, but had some basic questions that would have otherwise slowed down the review had we not already included material in the packet that some “rules lawyers” thought were not required per the guidance(s). I can barely begin to describe how much more reassuring it is to be on a 20-minute phone call with a reviewer and their more experienced peer/supervisor and to be able to say to the agents “That’s a reasonable ask, the information you are looking for is in volume ____ of the packet” instead of “We didn’t think you needed _____, do we really need to pull that together for you? Will this slow down the review?”