I don't know if I've got any concrete advice, but I can certainly chime in with my own experience...
We submitted a 510(k) last year for a Class II, and the reviewer had the same issue.
I went through the exact same trains of thought:
- "...but none of the nearly identical product currently on the market are labelled with a shelf life..."
- "...here is our evidence to back up the product life stated in the 510(k)..."
- " ...there is absolutely no risk to the user
even if materials were to degrade (rationale provided)..."
In the end, it was futile. We finally added a statement of shelf life to the label...which to this day I find ridiculous. It has yet to be seen whether this will just confuse end-users into mistakingly thinking the device is volatile and might somehow "go bad".
