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FDA suggests controls on interoperable devices

December 12, 2017

The final FDA guidance on design consideration and pre-market submission for interoperable medical devices was released on September 6. The demand for these devices is increasing in the healthcare system as our dependence on more rapid and protected interactions between devices grows. This increase presents a need for a parallel increase in adequate FDA regulations for this elaborate device field.

An interoperable medical device is one with the ability to exchange and use information with another medical or non-medical product, system, or device. An electronic interface is a medium by which these systems can communicate.

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