To whom who can answer my question,

I am a student and Towson University, Maryland. I am doing a project on the process of receiving classification which is obtained before the FDA classifies the device as Class 1, 2, or 3. The question i would like to ask you is that how microscopic is this process of giving a device a certain class? In other words, what can go wrong during the process of obtaining a classification for a device? Is it a fair simple process?

Thank you very much.
I look forward to your reply.

Sincerely,