There have been few innovative therapies marketed for patients with kidney diseases or kidney failure in the US in the last decade, while new therapies have been marketed in Europe and Canada years earlier. For medical device development, it is essential that device manufacturers and other stakeholders have optimal information regarding the standards and requirements for approval of clinical trial protocols and market approval for devices at the US Food and Drug Administration (FDA). A Kidney Health Initiative working group defined and studied a few broad categories of devices that have been marketed outside of the US. It determined the value of these devices in patient care, ascertained pathways to expedite approvals in the US, and summarized its findings.