CDRH Kicks Up Inspections on Device Trials

As an early intervention, the FDA is using a quantitative risk-based approach to inspections of device clinical trials, a CDRH official says. “In our risk-based approach, we have been trying to select small-to-medium IRBs [institutional review boards] as part of our early intervention program, as well as IRBs that have never been inspected or not in a very long time,” Michael Marcarelli, director of the Division of Bioresearch Monitoring at CDRH’s Office of Compliance, said.
Devices & Diagnostics Letter