SW (Software) changes during a pending 510(k)

[Rezzi]

Imagine the following:

We submit a 510(k) for a few changes to an existing device with SW version 1.0. During the 510(k) review and before we recieve the final SE letter, we decide to add an additional minor insignificant SW change (read a SW change that would not require a 510(k)) to a new SW version 1.1. Am I required to make an update of my pending 510(k) and inform FDA about this new SW change?

Thanks for any advice.

 

[Ronen E]

Imagine the following:

We submit a 510(k) for a few changes to an existing device with SW version 1.0. During the 510(k) review and before we recieve the final SE letter, we decide to add an additional minor insignificant SW change (read a SW change that would not require a 510(k)) to a new SW version 1.1. Am I required to make an update of my pending 510(k) and inform FDA about this new SW change?

Thanks for any advice.

I believe though formally you might get away with a letter to file only, since you are anyway dealing with the FDA's examiner - best inform them and have their "ruling" in writing on file.