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FDA finalizes guidelines on interoperable devices
The FDA recently issued final guidelines outlining its nonbinding recommendations for safe and secure interactions among medical devices and other information systems, calling for devices to be designed with interoperability as an objective.The guideline is intended to highlight what medical device manufacturers should consider to provide a “reasonable assurance of safety and effectiveness” for their interoperable medical devices, and provides manufacturers with design considerations and recommendations regarding information to include in premarket submissions and device labeling.