In agreement with this. You can have two similar functioning products but have different risk. An implantable suture that biodegrades into the body would have significant risk as these sutures are used to sustain life. However, you can also have a suture that applied topically on smaller wounds and removed which would have non significant risk. Before a clinical trial is ran, companies already have some form of draft of a risk assessment done. Companies have a very clear idea whether a product has significant or non signficant risk prior to reaching clinical trial stages