Official: FDA uses risk-based approach for device-trial inspections

12/7/2008 | FDAnews

The FDA is using a quantitative risk-based strategy as an early intervention in evaluating clinical trials of medical devices, said an official with the Center for Devices and Radiological Health. This method involves small and medium-sized institutional review boards as well as those "that have never been inspected or not in a very long time," the official said.

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