I suggest if you go and post links, you read & understand the...

I suggest if you go and post links, you read & understand the content of the link that you post & how it actually reinforces the point I made.

"FDA approval always requires a full clinical trial or trials, whereas the CE Mark can be obtained through a clinical evaluation—a review of published data for existing equivalent devices. For a clinical evaluation, the only requirement is that the manufacturer conduct a postmarket clinical follow-up study once the CE Mark is obtained. "

Basically any idiot can get a CE mark based on a , we can do an evaluation later .

The FDA requires you to show some evidence of efficacy up front, not necessarily through double blind studies. the level of proof varies depending on the category/class the product falls under. Lower risk = lower burden of proof.

But hey RAP is approved right ?