Recently, the U.S. Food and Drug Administration (FDA) finalized guidance summarizing its recommendations for interoperable medical devices, or devices that are connected to each other and to other technology. Noting the growing need and desire to connect medical devices to each other as well as other products, including products from different manufactures, FDA highlighted the devices’ potential to foster rapid innovation.
On the other hand, FDA pointed out that failure to address appropriate safety considerations in the device design can result in “unforeseen safety and effectiveness issues for the patient, operator, device or system.” Specifically, FDA pointed to various risks associated with connected devices, such as errors stemming from inadequate interoperability or the exchange of inaccurate, untimely or misleading information. Device malfunction, which could lead to patient injury or even death, is another concern for the agency.
Accordingly, FDA summarized its recommendations for device design and premarket submissions for device manufacturers. FDA said manufactures should clearly set forth in device labeling the functional and performance requirements of their electronic interface to minimize risks associated with failure to exchange and use data as intended. Moreover, manufacturers should identify the anticipated users of the electronic interface, and design the device and its electronic interface with this user population in mind. Manufacturers also should include risk management and verification and validation mechanisms as part of the design process.
As with all FDA guidance, this document is not binding on the industry and does not constitute regulation. However, it does represent FDA’s current thinking on this topic. As more interoperable devices are developed, FDA’s views likely will continue to evolve. FDA’s associate director for digital health in FDA’s Center for Devices and Radiological Health noted that FDA’s guidance is a “good step towards safer devices, and [FDA] will continue to work with all stakeholders to adapt along with the technology.”
If you have any questions about this guidance or other healthcare regulatory issues, please contact one of the authors below.