On August 13, 2013, the Food and Drug Administration (“FDA”) issued final guidance on design principles for medical devices using radio frequency (“RF”) wireless technology that are implanted or worn on the body and that are intended for use in locations such as hospitals, homes, clinics, and clinical laboratories. This guidance comes as the FCC and FDA continue to work towards regulatory initiatives for wireless-enabled medical devices. The FDA’s final guidance updates a draft originally issued in 2007.
Demand for wireless medical devices has exploded in recent years and continues to grow. The market for wireless monitoring devices, for example, has doubled in the past four years to $7.1 billion and is expected to triple in the next four years, to $22.1 billion. Meanwhile, some analysts have estimated that the demand for wearable medical devices alone will exceed 100 million units by 2016.
The Federal Register notice announcing availability of the guidance document explains that, while common, the use of RF wireless technology for medical devices carries some concerns where the devices are used in environments with multiple other sources of RF energy that could potentially affect the function of the device. The FDA guidance is intended to assist the industry in addressing the issues specific to developing wearable RF devices.
Key in the approach put forth by the FDA is the full assessment of safety issues related to the use of wireless technology and careful consideration of which device functions should be wireless. The guidance particularly encourages review of wireless quality of service, wireless coexistence, and the security of wireless signals and data, as well as electromagnetic compatibility. The guidance also includes information on appropriate labeling and considerations for product maintenance.
The FDA notes that many wireless medical devices will operate as unlicensed devices not entitled to protection from interference. As a result, the FDA urges developers to include error control processes and consider any limitations on proper operations in the event that the RF link is lost. In assessing the acceptable quality of service, moreover, the FDA advises developers to consider the “acceptable latency, acceptable level of probability for loss of information within the network, accessibility, and signal priorities of the network.”
In addition, the FDA notes that wireless medical devices would have to coexist with one another and that their design should take into account other expected RF wireless technologies. Device manufacturers should assess and test the RF interference risks related to co-existence, and risks deemed acceptable should be justified. Consistent with long-standing precedent, the FDA referenced testing of such devices under IEC 60601-1-2 (electromagnetic compatibility). In addition, the FDA recommends that wireless medical devices use wireless protection measures such as encryption and data-access controls.
To ensure devices are adequately installed, the FDA also advises developers to include reasonably specific set-up and configuration information for users, such as the specific RF wireless technology type, any limitations on the number, output power, or proximity of other transmitters that might adversely impact the device’s operation, and information about the device’s needed quality of service. Moreover, developers should anticipate nonconforming uses of their devices and incorporate those uses into their maintenance procedures. These procedures should generally manage risks associated with the entire life cycle of the device. If a failure or malfunction is identified, the developer must investigate and correct the problem as well as prevent its recurrence.
Finally, the guidance addresses the necessary content of a premarket submission for a wireless-enabled medical device. This included a device description that addresses the wireless aspects of the product, the expected wireless quality of service, risks arising from wireless device coexistence, risks to the security of wireless data and the measures taken to address such risks, a statement on the device’s electromagnetic compatibility, as well as summaries of all relevant test data. Finally, the guidance requests that product labeling address the issues discussed above.
These final guidelines are part of a government-wide movement to update regulations for the explosion of wireless medical technologies. The Federal Communications Commission, which has broad jurisdiction to manage the nation’s wireless frequencies, has opened several spectrum bands for medical purposes. For example, the Federal Communications Commission (“FCC”) recently issued final rules for medical body area networks (“MBAN”), which allow wearable medical sensors to operate on the 2360-2400 MHz band on a secondary basis. In addition to establishing technical parameters for MBAN devices, the FCC allowed these devices to operate without an individual license. The Commission also recently founded a new Healthcare Connect Fund that will support cost of broadband services or facilities used by rural healthcare providers.
Furthermore, the FCC authorizes wireless equipment, allowing it to set technical specifications and enforce compliance with its engineering standards. Thus, MBAN devices must now seek and receive FCC approval to be legally marketed or sold in the United States. Similarly, medical implant devices designed to restore sensation, mobility, and other functions to paralyzed limbs and organs (known as medical micro-power networks), which the FCC authorized to operate on certain frequencies in 2011, must make certain certifications and disclosures.
The new regulatory initiatives from the FDA and the FCC suggest both the promise and risks of next-generation wireless medical devices.