FDA Finalizes Guidance on Interoperable Devices

The US Food and Drug Administration (FDA) on Tuesday finalized guidance outlining recommendations on how medical devices should be able to securely interact with other devices and information systems.

The guidance, first drafted in January 2016, is meant to assist manufacturers and FDA staff in identifying considerations related to the ability of electronic medical devices to safely and effectively exchange information and use exchanged information from devices.

It also features help for companies designing and developing interoperable medical devices, and recommendations regarding information to include in device labels and premarket submissions...

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