Official Says FDA Guidance on IDE Decisions Aims to Improve Transparency, Efficiency

In issuing final guidance on investigational device exemptions (IDEs), the FDA hopes to make the decision-making process more transparent as well as reduce the time and cost of conducting these studies, the FDA’s acting director of device trials said during a Sept. 4 webinar.

Owen Faris, acting director of clinical trials for the Office of Device Evaluation in the Food and Drug Administration’s Center for Devices and Radiological Health, discussed the guidance, “FDA Decisions for Investigational Device Exemption Clinical Investigations: Guidance for Sponsors, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff,” published Aug. 18 and dated ...