FDA Begins Reorganization that Will Affect How it Regulates Medical Technology

What impact will the U.S. Food and Drug Administration’s significant reorganization efforts have on how the agency regulates medical technology? The agency is reorganizing the Office of Regulatory Affairs (ORA) and combining the Office of Compliance (OC) and Office of Device Evaluation (ODE) within the Center for Devices and Radiological Health (CDRH). The changes are part of its mission to better ensure patient safety and quality of medical devices in both the pre- and post-market settings.


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