It helps if a similar product is already approved in whatever country the company is trying to release their product. If it is a whole new product that is being brought to market most of the cost are going to be exorbitant. If it is a high risk PMA expect to pay millions of dollars. Part of this is due to the FDA process of reviewing in which delays occur and there is turnover within the company and regulators. Labeling issues with products add to cost. Also, regulations is a way to “weed-out” companies to see if they are truly serious about bringing a device to market. If you want to compare, the European Union process for cost of regulation is controlled mostly by physicians.