Exporting medical devices to the USA (How to do business with the Food and Drug Administration)

It is concluded that the Food and Drug Administration (FDA) is analogous to a referee of a soccer match. No matter what the decision, half of the attendees will be displeased. What is the lesser of evils? FDA's conservative, belt and braces corporate culture of keeping "bad" product off the market at the expense of "good" product, or the emphasis of getting good product to market along with some bad? Nevertheless, to do business in the USA in medical devices, all one has to do is: register the establishment; list the devices; obtain FDA approval before commercial distribution; implement a quality system in compliance with the quality system regulation.