Medical device manufacturers utilize a premarket notice (also known as a “premarket submission” or “510k”) to show the FDA that their device is substantially identical (as a “predicate” or “reference”) to another lawfully marketed item currently on the market. This makes it easier and faster for your firm to obtain its medical devices approved by requiring far less clinical trial evidence. The 510k submission process was created to aid in the introduction of novel devices that are “substantially identical” to those that are currently lawfully sold for the same purpose.