New FDA Guidance for Interoperable Medical Devices

The FDA just released their latest guidance on Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices (

The FDA position on this topic fits largely into the Medical Device industry expectations.  Where your device has an electronic interface that is intended to exchange data with another device, the following basics need to be considered (and documented as part of any submission):

  • Purpose
  • Anticipated Users and their use scenarios (both nominal and misuse)
  • Risk analysis including both anticipated use and misuse scenarios
  • Verification and Validation
  • Labeling

If your device is in this category, contact a Realtime expert to discuss how we can help provide submission ready documentation for your product that is aligned with this guidance.

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Don Hurd, VP Quality and Validation Services