FDA proposes new fast path to market for certain medical devices, page-5

Those "... burdensome regulations ....." are also there to 'save' lives, who takes responsibility for the failure of a product!

Will you?

The failure of the mesh product from Johnston and Johnston, American Medical Systems has been disastrous for numerous women, for a spec company, the failure of a product, would be company destroying, even the Giants take a hit in these cases.

That the POA is fulfilling this particular promise is also the same man that is fulfilling his promise to build the 'wall'!

As been mentioned before, special dispensation can be applied for to use a product yet to be approved, I have no doubt that there is a fair bit of 'ass' covering that goes on, right or wrong, before approval of any new product.

If the product is the real 'McCoy'/break thru tech IT will happen, that is, be approved.

I get the feeling sometimes that this 'rush' to see things get fast tracked is for ulterior motives, that is, sp appreciation and products in the market for a company to make profits from, to the cost, at times, the detriment of the end user, the patient.

A product that is 'break thru'/cutting edge WILL rise to the top and WILL be approved and WILL be successful!

Steady, solid focus by Admedus to bring its IP to the market place, if indeed cutting edge, WILL happen, though perhaps at a pace slower than we would wish for.