Hello, I hope I can find some guidance and advice on this forum. I am a Ph.D. with an idea for a medical device. It is a small appliance already available in the US market, although not for a medical use. My idea is to modify it slightly and market it for a medical use. The modification actually makes it safer for its current use as well. Using the modified small appliance, it is practically 100% effective and safe for the medical use. Other available treatments are either not completely safe, not completely effective, cost up to 10 times what mine would cost, or are not easy to access or execute. In other words they are a hassle, are expensive or don't work. So I think mine is definitely the best thing out there. I am looking for someone with knowledge of medical device law to give me advice. Perhaps someone who is an attorney or regulatory professional in this area. Optimistically I am hoping perhaps since it is already marketed (and my modification makes it even safer for its current intended use), the modified form could have an easier time going through FDA approval. If I need to go through FDA approval, what would I need to do in terms of a clinical trial? How much would it cost and how long would it take? I appreciate any help offered. Thank you for your time.