Daily Buzz

A debate comparing the European and US regulatory approval process and asking if the CE mark sufficiently ensures patient safety continues to rage on the Medical Devices Group page on LinkedIn.

Medtechinsider recently excerpted some of the comments that were posted on LinkedIn. Since then, several more people have weighed in. One comment that I found especially provocative came from Dr. Michael Ward, who questions the politics driving US FDA.

"I have always felt the FDA process has one major weakness. Many beside me have thought hard and long about a third-party review process that removed the politics from decision-making and overall regulatory process and infrastructure. That has yet to be identified and perhaps a successful overhaul of the FDA is always prevented by Congress, because [the politicians] don't want to lose control of a nice system they can bounce around like a tennis ball."

If you have any interest in this topic, you should definitely take a moment to join this conversation.