I Feel FDA rules are more like a filter to bad products from entering into market. With lot of competition in the market, some companies tries to cut corners and save time or even money. Since, any company’s main motto is to create a product that makes money and have a good business plan, FDA has to intervenes and protect public health by assuring the safety and efficacy of drugs or devices. As a0242 mentioned, FDA is not too rigid. Moreover, it has been amending acts and rules to fit the needs of present day scenario based on the market and needs.