I don’t think the FDA is being too strict. With anything that is new, there has to be accountability. The regulations that are put in place, forces companies to be ethically sound when proposing new technology that can have negative impacts on the lives of people if corners are cut. No impact should be considered small enough to warrant a lack of due diligence on both the company proposing the device and the FDA in regulating it. We often step back from situations if it does not directly pertain to us or someone we know. How would you feel if one of your loved ones were negatively impacted due to a device getting cleared by the FDA under a less strict regulation procedure?