Over on the Medical Devices Group, I asked,
Is a CE mark “good enough?”
Responses came pouring in.
“As you know, medical devices sold in America require FDA clearance. Is gaining FDA clearance more stringent than obtaining a CE mark?
And a question for regulatory experts in our group: Is it defensible for your sales reps to say to a prospect, “Well, our device has FDA clearance and the competitor only has a CE mark,” the clear inference being FDA clearance is “better” so you should buy my product instead.”
The kind folks at MedTechInsider published my summary today. Click through to read it.