This message was posted by a user wishing to remain anonymous
Hi
In the past we submitted with special 510k for systems with embedded SW, we submitted all the SW reports and went well.
Now due to recent submissions where the reviewer sticks by the guidance, we are afraid it will turn the submission to traditional.
The alternative is to summarize the testing which will require too much time and effort as we have multiple test cases with different acceptance criteria.
Any insight? Recent experience?