The FDA issued its final guidance for medical device interoperability on Sept. 6, 2017. The guidance offers insight into what the agency is looking for in terms of safety and effectiveness for medical devices that are connected to each other and to other technology.

The agency’s intention is to promote development and availability of safe and effective interoperable medical devices Bakul Patel, associate director for digital health in the FDA’s Center for Devices and Radiological Health told Kapstone Medical.

“The intention for drafting and finalizing interoperability guidance was due to the growing need and desire to connect medical devices to other products, technologies, and systems in the health care community,” Patel said in an email interview.

“As electronic medical devices are increasingly connected to each other and to other technology, the ability of these connected systems to safely and effectively exchange and use the information that has been exchanged becomes increasingly important.” 

The guidance aims to assist the medical device industry in identifying considerations that should be included in the development and design of interoperable medical devices and provides recommendations for the content of premarket submissions and labeling of such devices.

Patel, summarized the highlights of the guidance in an article on the website of the Center for Devices and Radiological Health (CDRH). The FDA’s recommendations for smart, safe and secure communication between medical devices and information systems include:

  • Design devices with interoperability as an objective;
  • Conduct appropriate verification, validation and risk management activities
  • Clearly specify the relevant functional, performance, and interface characteristics to the user

In addition, the guidance recommends appropriate functional, performance and interface requirements and the consensus standards that support interoperability include data format, architecture design, and other aspects of interoperability. 

The guidance allows device makers to use their own design preferences for their interfaces in lieu of the published consensus standard as long as obstacles to interoperability are minimized and functional, performance and interface requirements are openly available to all users.

The FDA issued its draft guidance last January and the final guidance includes comment and input from industry, designers and the public, including recommendations for devices requiring premarket submissions to the FDA.

“Most changes in the final guidance clarified language and added examples based on received feedback, such as the importance of time synchronization,” Patel said. “Our guidance incorporates many comments received from the medical device industry, designers and the public.”

The guidance also encourages manufacturers to provide information needed by other devices and medical systems to interface with their devices so that those devices and systems can safely and effectively exchange information with those devices.

The full text of the guidance was published in the Federal register on Sept. 6, 2017. If you are looking for an advisory partner, Kapstone Medical is well versed in regulatory planning, 510(k) submissions, CE Mark and quality systems development.


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