An increasing number of devices employ radio frequency wireless technology. This trend is likely to continue. These devices present some new technological issues. To respond to these new issues, FDA has just released a draft guidance titled, “Radio Frequency Wireless Technology in Medical Devices.” The purpose of the guidance is to “assist industry and FDA staff in identifying and appropriately addressing specific considerations related to the incorporation and integration of radio frequency ("RF") wireless technology in medical devices.” The guidance states that there are certain RF considerations that can affect the safe and effective use of medical devices, namely, selection of wireless technology, quality of service, coexistence, security, and electromagnetic compatibility ("EMC"). The guidance describes the various issues for a manufacturer to consider with respect to design, testing, and use of wireless medical devices, and information to include a premarket submission for devices that incorporate RF wireless technology.
Design, testing, and use of wireless medical devices. With respect to the design, testing, and use of wireless medical devices, the guidance suggests that manufacturers “consider the ability of their devices to function properly in the intended use environments where other RF wireless technologies will likely be located.” FDA states that it will be important for the manufacturer to assure the “correct, timely, and secure transmission of medical data and information” for the safe and effective use of both wired and wireless devices, though, given the expanding use of wireless devices, the majority of the guidance discusses issues unique to those products.
The guidance makes clear that it will be important for a manufacturer to conduct a risk analysis that includes testing to show that the device can operate safely and effectively in the intended environment; the wireless network selected is appropriated for the intended use of the device; data integrity will be protected; and steps have been taken to minimize the likelihood of interference with other devices. Additionally, the guidance provides suggestions for information to include in the instructions for use to help ensure that the user can safely and effectively operate the device.
Information to include in a premarket submission. The guidance states that FDA would like to see certain “information specific to the wireless technology and functions.” This includes a description of the technology and functions, the intended use environment, a description of how the device design assures timely, reliable, accurate, and secure data and wireless information transfer, and a discussion of whether other wireless products can make a wireless connection to the device, and, if so, what design features have been incorporated to protect the subject device from such interference. Additionally, a pre-market submission would need to include information about verification and validation of the device, such as information about the wireless quality of service appropriate for the device, any risks and potential performance issues associated with wireless coexistence, and any testing performed, including protocols and results. The submission should also include information addressing the security of wireless signals and data and EMC of the wireless technology. Finally, the submission should include labeling that includes risk mitigation measures that address RF wireless issues and precautions users should take.
Given FDA’s recent statements expressing concern about the safety of devices with wireless, Internet- and network-connected features (see our previous post here), companies with RF wireless devices should carefully review and consider the issues set forth in this guidance.