Vivos Inc (RDGL)

[nbm16yankees]

So how do we interpret this PR?

I am a little confused.. In the PR it states:
"The FDA, which previously advised AMIC that it would review the product as a medical device, has further advised AMIC that it has determined that the product is classified by statute as a Class III medical device, unless the device is reclassified. The Company intends to work with the FDA to seek such reclassification, unless the additional steps required for approval of this product as a Class III medical device are more efficient. The Company has obtained input from the FDA regarding its alternatives and will seek further input to expedite the process."

What is the difference between a medical device and a Class III medical device??? Which is better and quicker to obtain?
How much of a delay will this cause?
Are they satisfied with the way it works or is there a problem??
Why does the company have to seek further input and from whom, to expedite the process? Why couldn't the FDA make it easy and tell them upfront what needs to be done?