From my past experience working at two different medical device companies it always seems that the FDA is extremely tough and is very difficult to work with. I do think that FDA is slowing down the process by dragging out different stages of approval and testing. However, I do not think that FDA is being too strict. When it comes to medical devices, and especially implantable medical devices, they pose a serious health concern and risk for the user. If enough time is not taken to clear and allow a new medical device to the hit the market then the users can become seriously injured from the body rejecting the device or the user can die due to complications from the device that were not accounted for. I think the middle ground is the FDA allowing devices that pass for the Humanitarian Device Exemption to be used on individuals who are extremely sick and do not really have any other option but attempting to use the device or drug. In addition, when it comes to drugs such as vaccines, it is important that the device is 100% safe and effective considering it will be administered to possibly millions of individuals. It may take years to approve devices or drugs, but it is important to save lives and to make sure that the products that do make it through the process, are the best and will stay on the market for a long time. I believe in the future, devices that are not new and pose no serious risk should be advanced through the market a lot quicker, and should have fewer regulations and years of testing.