Jan 29, 2016

Medical device regulators at the US Food and Drug Administration have published new guidance targeting how manufacturers of electronic interoperable devices design their products as well as what to include in premarket submissions to the agency.

The guidance does not prescribe a single design approach for interoperable devices, but recommends that manufacturers take into account information, functional and architectural models during their products’ design and development phases. Furthermore, the guidance highlights five key areas manufacturers should bear in mind during their design and development efforts:

  • Purpose of electronic data interface: What types of data exchanges are taking place?
  • Anticipated users: What are the device’s anticipated users—clinicians, biomedical engineers, technologists, medical device designers, etc.?
  • Security and risk management: How does the manufacturer plan to mitigate risks arising from other parties or systems interconnecting with the device’s electronic data interface?
  • Verification and validation: Setup and maintenance of verification and validation processes are necessary to ensure electronic data interfaces work properly before product delivery.
  • Labeling: Information on how users should connect predictably and safely to the device’s interface should be included on product labels.

What to include in FDA premarket submissions

Considering the issues the FDA addresses above, the agency accordingly recommends information pertaining to those areas is included in manufacturers’ 501(K), Premarket Authorization (PMA) and other US premarket submissions.

Device description: Information on any electronic data interface utilized by a device should be included in a device description, as well as the interface’s purpose and anticipated users. Any data intended to be exchanged with other systems or devices should be covered in this section, as well.

Risk analysis: Risk analysis should include any and all risks attributed to interoperability of the device. Even if risks fall under the “broadly acceptable” category described in ISO 14971, the manufacturer should still mention these risks in a premarket submission.

 Verification and validation: Performance testing included in a premarket submission should include verification and validation testing results for an interoperable device’s electronic data interface. Results verifying that the device interface meets design specifications, performs as intended and that information provided for users to connect to the interface is correct should all be included submitted documentation.

Labeling: Information regarding the device’s electronic data interface should be included on the device label. In addition, if the device is designed to interact with one or more specific devices, those other products must also be listed on the label. Other information to include on interoperable device labels include purpose of device interface, accessibility of data, interface specifications and relevant standards used in the device.

The FDA’s interoperability recommendations follow recent guidance on cybersecurity risk mitigation for medical devices. 


  • Stewart Eisenhart