The answer to this question depends on the nature of your product, and what 'class' of medical device it would fall under. Depending on what class it is, the process could be as easy as filling out a simple form and sending it to the FDA, or it could be as hard as a multi-year multi-million dollar process involving clinical testing in hospitals. In either case, I'd be happy to map out the process for you.

Feel free to send over more background info and I'll look it over.

best,

Lee