I do agree that the FDA is strict to an almost oppressive extent, but given the types of products they are dealing with, it makes sense. The rigorous and lengthy process of releasing a new product to the public ensures that it is for the right reasons and not just to fool people and make a quick buck. People can’t just give you something they cooked up in a garage that contains components which could seriously harm or even kill you if used. Extensive trials need to be conducted which prove this product will do exactly as intended and not have any serious side effects. This requires time and money, but that is the cost of possible saving hundreds and thousands of lives, if that is the application. Even working for a medical device company and seeing some of the hoops you need to jump through during this process, I understand it and realize it is easier to just comply with them than try to fight it. If something were going to be used inside me body to augment function or even keep me alive, I would want it to have been properly vetted. Even through all this regulation we still see products recalled anyway, so some mistakes make it through the cracks regardless.