Story time: I'm from Germany, co-founder of a company that builds lasers which are marketed toward users in biomedical research. So when selling into the USA we

Story time: I'm from Germany, co-founder of a company that builds lasers which are marketed toward users in biomedical research. So when selling into the USA we've to deal with the FDA twice: Because the application is medical and because these things are lasers (little known fact: The FDA also oversees laser safety regulations and enforcement). In February I attended a conference in San Francisco and at the end of the week came down with benign infection; anyway I was headed to a pharmacy looking for some remedy; the first thing that had the label "FDA approved" on it I took. Why? Because I know firsthand how strict the FDA is and that they are a no-bullshit agency, so I knew that this thing surely was safe and be effective. BTW: Getting a new medical device FDA approved is not a very time consuming process; at least not for diagnostic applications. It can be done in under half a year, if your paperwork is thorough and your testing solid.