While we’re talking about FDA guidelines and resistance to them, our sister site Health Tech Insider carries an interesting story about someone looking for test subjects for a new wearable band. The developers plainly understand that they will, at some point, need to get approval from the FDA but they want a few people to see if their version of electrical muscle stimulation is perfectly safe before they invest the time and money.
There are a few ways this could be OK: they could be working with a medical ethicist or academic institution, for instance. Or they could be a bunch of guys in a Silicon Valley garage with a Really Neat Idea to get funded.
Be careful out there, OK?