Device Interoperability: US FDA Details Expectations In Final Guidance

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...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Digital Technologies

More from Medtech Insight