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Medical Devices / Submissions and Approvals

FDA Seeks to Build Risk-Benefit Database for Robotically-Assisted Surgical Devices

March 4, 2019

The FDA is monitoring adverse events involving robotically-assisted surgical devices, the agency said in a safety communication Thursday.

The FDA reviews such devices on an individual basis based on the complexity of the technology and its intended use, according to the FDA. The agency continues to monitor adverse events in the literature and those reported to the FDA to collect data on their benefits and risks.

In the meantime, the agency is encouraging device experts, manufacturers and professional societies to develop patient registries to gather data on the use of such devices, including for prevention and treatment of cancer.

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