Zinco, I know very little about how the FDA works but maybe the info here might help: Clinical Trials Guidance Documents .

I am more familiar with the UK system (I worked there for many years). In the UK there is what is called the "Yellow Card" scheme - anybody (patient or clinician) can report a suspected side-effect of a medical procedure: https://yellowcard.mhra.gov.uk/ .

I don't know if there is an American equivalent of Yellow Card.