I’m about to finish up a senior project and about to demo it very soon. One of the assignments I needed to complete was to classify the device based on what the FDA would think of my device. At first it seemed like I knew exactly what class it was, but as I examined my device more as well as what the classes actually entailed, I became very confused. I asked Dr. Simon for advice and he helped me in solving this dilemma by suggesting de novo 510k, because my device was significantly novel and really didn’t have any predicate devices. I had to really examine what this device was and what the FDA would assume was its main purpose.

So my question to you guys, have you every worked on a project or a medical device and the line between device classification was blurred? If so, how did you solve the issue of classifying the device based on FDA standards?