Regulatory Policies and Positions Affecting Device Approval in the US

Abstract

In the US there have been few innovative therapies marketed for patients with kidney diseases or kidney failure in the last decade, while a number of new therapies have been marketed in EU and Canada. The workgroup defined and studied 1-2 broad categories of these therapies, determined their value in patient care, and ascertained pathways to expedite approvals in the US. 

Patient Care Issue

There have been few innovative therapies marketed for patients with kidney diseases or kidney failure during the last decade. In addition, many innovative therapies are marketed in Europe and Canada years earlier than in the United States.

Challenge

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).

Solution

KHI assembled a workgroup that defined and studied a few broad categories of devices that have been marketed outside of the US. The workgroup is determined the value of these devices in patient care, ascertained pathways to expedite approvals in the US, and then summarized their findings in a white paper.