Typically yes. Device manufacturers usually opt for the 510(K) equivalence pathway and typically get it. If they are truly first to market they may have to pay for studies to get coverage but that is the exceeding minority. Also, most devices are not approved by the FDA but rather cleared. Separate pathways with different bars. Can you tell who's wife is in regulatory? First pharma and now med device
I used to work in medical affairs for a RT device manufacturer, and part of my job was regulatory. I guess I will have to use proper terminology next time rather than firing off the cell phone hip.
I always found it curious that condoms and linacs are both 510(k) class 2 devices.