The Food and Drug Administration (FDA) and Center for Devices and Radiological Health (CDRH) have announced efforts to modernize the 510(k) clearance pathway for medical device approval. Device manufacturers more frequently use the 510(k) pathway than other pathways to market. To gain market approval under 510(k), the manufacturer demonstrates that their device is substantially equivalent to an already marketed, or predicate, device. The 510(k) pathway is faster and easier than for devices that have no predicate. Modern devices are more technologically advanced than devices from even ten years ago. Because of its reliance on existing devices, there are concerns that following the 510(k) pathway may inhibit advancements in technology.