U.S. Food and Drug Administration

About

The U.S. Food and Drug Administration (FDA) is a federal regulatory agency responsible for protecting public health by ensuring the safety, efficacy, and security of medical devices, including surgical robotics systems. The FDA provides regulatory clearance and approval pathways for robotic medical devices through its Center for Devices and Radiological Health, establishing standards that govern the development and commercialization of medical robotics in the United States. The agency plays a critical role in determining which robotic surgical systems can enter the market and under what conditions they may be used.

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