FDA Issues Interoperable Medical Devices Final Guidance Document

On September 6, 2017, FDA-CDER & CBER issued a final guidance document entitled Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices.

The guidance document defines an interoperable medical device as a device with the ability to exchange and use information through an electronic interface with another medical product or non-medical product.

During the design phase the guidance recommends applying these considerations to the interface:

  • Purpose of the electronic interface
  • The anticipated users
  • Risk management
  • Verification and validation
  • Labeling considerations
  • Use of consensus standards

Pre-market submission should include:

  • A device description
  • Risk analysis
  • Verification and validation
  • Labeling

The Federal Register announcement says that FDA recognizes that it would take up to 60 days to put the guidance document in place. Pre-market submissions for interoperable medical devices made after 60 days should include the information covered by the guidance.

FDA plans to hold a webinar on the guidance document on October 26, 2017.