In the lecture Dr. Simon mentioned that if your device posses a significant risk the FDA might require clinical trials. I know there are other reasons for why a product might require clinical trials but what is meant by “significant risk”? Does a product present a significant risk if the lives of humans are in danger or simply if any injury is caused to the human body ? What is the borderline between “significant risk” and “non-significant risk”? Let me know what you think about this.

Sincerely,
Roberto Pineda.