FDA Final Guidance: Interoperable Devices

The FDA issued the final guidance entitled “Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices.” This guidance addresses medical devices that exchange information; whether wired or wireless, or through the internet. It includes unidirectional exchange, bidirectional, or command and control. The guidance focuses on data exchange not physical connection types. It includes a section on information on interoperability to be included in premarket submissions.

Section V identifies six key considerations under 21 CFR 820. Key design considerations identified include:

  • purpose of the electronic interface
  • anticipated users
  • risk management
  • V&V
  • labeling
  • use of consensus standards

Section VI of the guidance defines information to be included in premarket submissions, including a description of the API (Application Programming Interface) if the software can be used by other software, medical devices, or systems.

Take a look at the guidance here:  Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices

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