FDA Issues Wireless Device Guidance

The U.S. Food and Drug Administration (FDA) has issued its most up-to-date guidance on wireless medical devices. Released by the FDA’s Center for Devices and Radiological Health (CDRH), it is titled “Guidance for Industry and Food and Drug Administration Staff; Radio Frequency Wireless Technology in Medical Devices” and addresses the agency’s recommendations for devices that are implanted or worn on the body, and others intended for use in locations such as hospitals, homes, clinics and clinical laboratories. The guidance also deals with considerations that relate to the design, testing, deployment and maintenance of safe, reliable, and secure wireless medical devices and systems. 

According to the FDA, the guidance document was designed to assist industry and agency staff in identifying and appropriately addressing specific considerations related to the incorporation and integration of radio frequency (RF) wireless technology in medical devices. 

“There has been rapid growth in medical devices that incorporate RF wireless technology due to the expansion of this technology. With the increasing use of RF wireless medical devices, continuing innovation and advancements in wireless technology, and an increasingly crowded RF environment, RF wireless technology considerations should be taken into account to help provide for the safe and effective use of these medical devices,” the guidance reads. “This guidance highlights and discusses RF wireless technology considerations that can have an effect on the safe and effective use of medical devices.  These considerations include the selection of wireless technology, quality of service, coexistence, security and electromagnetic compatibility. Consideration of these areas can help provide reasonable assurance of safety and effectiveness for medical devices that incorporate RF wireless technology, and are supplementary to other device-specific guidances or guidelines. 

FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, a guidance describes the agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  The use of the word should in agency guidance means that something is suggested or recommended, but not required.

According to a blog post written by Bakul Patel, senior policy advisor at CDRH, many medical devices today perform at least one function by using wireless technology to support healthcare delivery.

“In telemedicine, for example, a wireless device can enable real-time monitoring of patients from a distance – data from a patient-worn or implanted medical device goes directly to the health care professional,” he wrote. “The transfer of data is immediate, accelerating communication, decision time and when necessary, intervention.”

He outlined a few worst-case scenarios:
• What if a diabetic’s blood glucose monitor malfunctions and sends a wrong glucose reading to a doctor because another wireless device in the clinic interfered with its signal?
• What if a signal is completely interrupted from a monitor that the patient depends on to transmit time-sensitive health care data?  

In such cases, Patel added, the proper functioning of wireless medical devices can mean the difference—literally—
It is essential that manufacturers first consider and test potential limitations of the wireless connectivity associated with their devices to prevent malfunctions that could harm patients, he advised.

Designers and manufacturers of wireless medical devices should consider whether these devices can function properly in the environments where they are intended to be used. Another consideration is wireless coexistence. Given the limited availability of the radio frequency spectrum, wireless technologies may compete for access to the same spectrum. As a result, coexistence issues may pose risks that could result in medical device signal loss or delay that can be life-threatening, according to the FDA.

To develop the guidance, the FDA worked with the Federal Communications Commission.

FDA Commissioner Margaret A. Hamburg, M.D., has said that while the benefits of RF wireless technology are clear, “to harness the full power of these benefits, we must navigate a delicate balance between innovation and safety and effectiveness.”