I tend to agree with you that some accountability is required....

I tend to agree with you that some accountability is required. Especially in this instance. TIS have been gifted additional time by the regulator to get everything sorted due to imposed delays and that extra time should have been used to better effect.

But the CE Mark has not been withdrawn. It's not back to the drawing board and onto the FDA approval jsut yet. I think the decision to get going on FDA approval will turn out to be a wise one. Probably something they should have done sooner.