[otoburb]

>>It's usually pretty quick/easy to get stuff approved for in-lab, early human trials.

I'm surprised -- I thought that even if you had an eager group of volunteers for in-lab, early human trials you still needed to jump through understandably onerous red tape and provide reams of documentation and evidence that the device was safe.

Or does signing a (supposedly ironclad) waiver absolve your right as an early human trial participant to sue in the event of failure or adverse side effects?

[caycep]

shortcut is a humanitarian device exemption (HDE) if you have some good preliminary data, not sure what the exact rules are.