Prior to reading this article I had not heard of "registration study" as a pathway to FDA approval so I did some research. Still not clear on why we would choose that route other than there would be no competitor. I'm interested to learn from anyone out there that has any additional insight.

In the meantime, I'm putting this link out for those who want to learn more about registration studies.

http://www.clinicaldevice.typepad.com/cdg_whi...d-how.html