USA – FDA says IRB review still needed for IVD studies involving human specimens

The US Food and Drug Administration (FDA) reiterates that clinical studies of in vitro diagnostic devices (IVDs) using leftover, « deidentified » human specimens still have to be approved by Institutional Review Boards (IRBs).

This pronouncement was made in an 18 October reminder letter to IVD manufacturers by William Maisel, chief medical officer and director of the Office of Product Evaluation and Quality within FDA’s Center for Devices and Radiological Health.

The IRB approval requirement applies to investigations using leftover deidentified human specimens  supporting an investigational device exemption, a marketing application, and to IVD technical or analytical studies that use human specimens…