I feel like the FDA approval process seems like it is too strict compared to regulations in other countries, but I agree that the FDA is right in being as extensive as it is. The FDA was originally put in place to regulate the food industry because there was no way of proving that labels were accurate as to what companies were putting in the product. Since then the FDA has overseen the medical device and drug industries to ensure efficacy of the products and protect the consumers. For products classified as class iii devices, a sufficient amount of evidence is needed in order to ensure a product is safe enough to be used in situations where they are supporting/sustaining life.