The Food and Drug Administration (FDA) issued guidance yesterday (September 6, 2017) entitled “Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices,” which is intended to “assist industry and FDA staff in identifying specific considerations related to the ability of electronic medical devices to safely and effectively exchange information and use exchanged information.”

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.”

The guidance focuses on risk management for the electronic interface incorporated into the medical device. Considerations to be evaluated include:

  • The Purpose of the Electronic Interface
  • The Anticipated Users
  • Risk Management
  • Verification and Validation
  • Labeling Considerations
  • Use of Consensus Standards

The recommendations for contents of pre-market submissions include:

  • Device Description—the sponsor should include a “discussion of each externally-facing electronic interface found on the device, the 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, reasonably foreseeable misuse, and “reasonably foreseeable 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, so that the device can be used safely and effectively.”

The FDA acknowledges that the industry may need up to 60 days to implement the guidance for submissions, so this information will not be requested by staff in the next 60 days. It appears from the guidance that all submissions thereafter should include the information contained in the guidance.