I agree with the above post but, I think the criteria in general have to be further explained. If you look at the requirements from the site all of them say “serious risk”. This brings up the question in the original post asking what qualifies a “serious risk”. Also what makes something serious as opposed to not serious? I think a “serious” risk would be something that can potentially cause harm in the body. This can be from any injuries to any body components or creates some sort of morphological change within the human body. I’m sure you guys can think of more risks that are involved, those two were the two that came to my head first. But, I guess anything that has some sort of adverse reaction or has the ABILITY to create an adverse reaction would be classified as a “serious risk”. And then obviously, clinical trials would need to be performed to discover and eradicate those adverse reactions. On the other hand, something that doesn’t really affect the body would be your non-serious risk devices.

Tell me what you guys think. What are some other potential risks that you can think of.