I can see why many would think the FDA are being strict and potentially hampering the journey of medical devices. However, the FDA is a regulatory board and its main job is to be an overruling force. If the FDA were to lax its rules, many companies will take shortcuts to bring the device to the market a lot quicker. This may result in a lot more cases of damage to the general population. Companies can argue that certain rules and regulations are stretching the power of the government, and in certain cases I agree. However, it is hard to nitpick over specific rules. The FDA has been in this position for a long time and has accumulated years of data. This data would be a benchmark to see if their rules and regulations are too much or are they working fine. There will always be recalls of medical devices, but with a strict government agency in place to look over it, a lot more recalls are prevented.