question about clinical trial

aihara
Thu, 12 Jul 2007 15:05:34 +0000

If an independent individual (not affiliated with any hospitals, schools, etc…) or company come up with a device that can be used in the medical field, they technically need FDA approval before it can be marketed for medical use. Most of time, this requires a clinical trial right?

My question is, does the clinical trial have to be performed by certified professionals in the field (MDs, doctors, etc…) or can it be performed by layperson also?

And if it have to be performed by experts in the field, how does one contact/find such people? Do they usually require monetary compensation in order to do a clinical trial for you?

I’ve already got volunteers. But I just don’t know what kind of requirements the FDA requires for the clinical trial. And how to go about it…

Anyone with any knowledge in this area, please help.

Thanks