These costs have a bigger impact in those companies that are just starting and don’t have a big budget. Big company have no problem with paying a lot of money for it because they have a big budget. The FDA (I’m gonna use it as an example) uses these expensive standards as a barrier for companies to enter the medical devices field (Which makes sense to me because they would prefer dealing with 10 companies that produce medical devices in the New Jersey region rather than dealing with 25). I am sure there are more barriers to enter this market but this one is not present in all the markets of the United States. So from a FDA point of view it makes sense to have these expensive tags.