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Device Interoperability: US FDA Details Expectations In Final Guidance

 
• By Elizabeth Orr

Electronic interface functionality, data-exchange factors and time synchronization are among key interoperability factors for device-makers to consider in device design and pre-market submissions, US FDA says in a final guidance document. The guidance stresses the need for developers to consider potential risks of interoperability from device conception and throughout the lifecycle.

A newly finalized guidance document from US FDA urges firms to incorporate device interoperability design and assessment from the beginning stages of product design. Companies should pay close attention to electronic interface functionality, data-exchange factors and time synchronization, among other challenges, the agency states.

The 21-page document spells out several specific concerns related to devices’ ability to safely exchange and use identifying information wirelessly or over ports such as USB, as well as strategies the agency expects manufacturers to use to mitigate any risks tied to interoperability

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