I have worked for 30 years in the diagnostic industry that is regulated by the FDA. I have had at least 20 products go through the regulatory 510K process, and have found the FDA to be both difficult and tough. But they often ask excellent questions, demand the highest in quality and generally help industry improve the quality of their product. As a significant stakeholder in multiple diagnostic companies, I know there is a cost associated with regulation, but without it we are left with a higher incidence of tragedy and unintended consequences that we all regret. So when you wish for a gift (present), make sure you know what you are getting.
Stanley M. Liffmann