This is the old story of regulatory bodies wanting to be able to...

This is the old story of regulatory bodies wanting to be able to refer to the playbook of traditional methods of proof.
The problem comes when you are on the cutting edge of new medicine and the playbook does not apply.
What is needed in these situations is a person of knowledge who can educate the panel to a satisfactory level while stroking their ego's and not making them look stupid.
It's a very difficult line to tread.

Having said this, it your product gets across the line at this point, it becomes the reference standard and you are then in the inner sanctum.
The walls to this inner sanctum, along with patents then become barriers to entry which your competitors need to overcome.

A big and pivotal hurdle to overcome, but one that must be overcome nonetheless.