WHAT:  FDA position and guidance on medical device interoperability  – ability to safely, securely, and effectively exchange and use information among one or more devices, products, technologies, or systems.

WHY:  Interoperable devices with the ability to share information across systems and platforms can:

  • Improve patient care,
  • Reduce errors and adverse events
  • Encourage innovation.

WHO: CDRH – along with  hospitals, health care providers, manufacturers, standards development organizations, and other interested parties to promote medical device interoperability.


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