The Food and Drug Administration (FDA) released its “Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices (Final Guidance),” Sept. 6, 2017, representing current recommendations for the design, development, and marketing of interoperable medical devices. The guidance highlights “considerations that should be included in the development and design of interoperable medical devices, and provides recommendations for the content of pre-market submissions and labeling for such devices.”

Several key design consideration points include:

  • Device purpose and design
  • Anticipated users
  • Risk management
  • Consensus standards

Also in the Final Guidance is verification and validation, labeling, and contents of premarket submissions. Recommendations for contents of pre-market submissions include:

  • Device description – Sponsor should include a discussion of each externally-facing electronic interface found on the device, purpose of each interface, and the anticipated users of the interface
  • Risk analysis – Manufacturers should complete a risk assessment that considers the risks associated with interoperability, and reasonably foreseeable misuse and combinations of events that could result in a hazardous situation
  • Verification and validation – A sponsor should include results of verification and validation testing for the electronic interface on the device
  • Labeling – Information regarding the electronic interface on the device should be included in the labeling, allowing the device to be used safely and effectively