Any device that is going to be expected to help save and prolong human life should be strictly regulated. I believe people should have full confidence in anything they purchase that is expected to save their life. I also believe that more holistic medicines should be allowed to be marketed but not receive the FDA approval. I believe if a person is informed that a medicine is not approved by the FDA, and continues to desire the medication they should be allowed to do so. I also feel like a lot of the FDA regulations can be tedious and fixated on details that do not really affect the product functionality or effectiveness. When a company is forced to use an entire Engineering department just to regulate paperwork alongside a document control department then it can be detrimental to mankind. When very intelligent men and women are forced to spend their time worried about paperwork rather than the greater good the FDA seems to be more of an enemy than ally.