What Constitutes a Medical Device?
At the time of writing this column, Fashion Week had just concluded in New York City. Without waxing philosophical about what constitutes style or beauty, as the author professes to possess neither, and claims no French heritage, it did make one ponder about a growing array of aesthetic products on the market today. For example: • Is a product that is a machine used for aesthetic purposes a medical device? This aesthetic medical product does pose risk to the recipient—and potentially the user. Furthermore, the product contacts the human body and is invasive. However, it only purports aesthetic benefits. • By the same token, what about a cosmetic product that is implanted into one’s lip to increase the tissue mass of the lips to make the lips appear fuller? Despite the fact that the acknowledged level of risk of using these products is similar to that for medical devices, the first product generally is not considered a medical device because an aesthetic purpose typically is not interpr