Regulatory Policies and Positions Affecting Device Approval in the US

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 U.S. Food and Drug Administration. A workgroup was assembled that defined and studied a few broad categories of devices that have been marketed outside of the United States. The workgroup is determining the value of these devices in patient care, ascertaining pathways to expedite approvals in the United States (if appropriate), and then summarizing their findings in a white paper. Learn more about this project here.

Hemodiafiltration to Address Unmet Medical Needs ESKD Patients Regulatory Considerations for Hemodiafiltration in the United States