I think the reason the FDA is so harsh when it comes to rules, regulations, and the process to approve a device/treatment is because of liability issues. If a patient/customer is not satisfied with the device or shows any adverse effects, it becomes a huge issue. Not only would companies lose money, but patients can also become hurt or ill as a result of devices not working properly. Also, as people have already stated before, the FDA needs to maintain a competitive market to ensure that innovation will continue. Unfortunately, the process for approval can be very long, making it very inconvenient for companies trying to create revenue off of the product; however it is important to remember that these devices are usually meant to treat illness. From the opposite perspective, I think it would be worse if the FDA had regulations that were less strict. More people would show adverse effects as a result.