The U.S. Food and Drug Administration has published final guidance 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.
"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," states the FDA document. "This guidance highlights and discusses RF wireless technology considerations that can have an effect on the safe and effective use of medical devices."
Among the considerations emphasized by the FDA are the selection of wireless technology, quality of service, coexistence, security, and electromagnetic compatibility. According to the regulatory agency, consideration of these issues should be considered for all medical devices that incorporate RF wireless technology, such as Wireless Medical Telemetry Service, Medical Device Radiocommunication Service (including the former Medical Implant Communications Service), as well as Medical Micropower Network and Medical Body Area Network (MBAN). The guidance also provides recommendations for information to be included in FDA premarket submissions for medical devices and device systems that incorporate RF wireless technology.
"The proper functioning of wireless medical devices can mean the difference--literally--between life and death," wrote Bakul Patel, senior policy advisor in FDA's Center for Devices and Radiological Health, in an Aug. 13 blog. "It is FDA's role to assure that before such wireless medical devices are introduced into the marketplace, that they have been properly tested. 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."
The recommendations in the FDA guidance are intended for RF wireless medical devices including those that are implanted, worn on the body or other external wireless medical devices intended for use in hospitals, homes, clinics, clinical laboratories, and blood establishments. In addition, both wireless induction-based devices and radiated RF technology device systems are within the scope of the agency's guidance, while the use of RF energy to generate images of the internal structures of the body, such as in magnetic resonance imaging systems, is outside the scope of the guidance.
The FDA argues that its guidance 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." However, at the same time, the FDA is quick to point out that its final guidance, like the agency's other guidance documents, does not establish legally enforceable responsibilities but rather describe the FDA's "current thinking" on the topic.
As such, the agency said that its guidance should be viewed only as recommendations, not specific regulatory or statutory requirements, unless otherwise cited that way. For instance, the FDA said that requirements by other agencies were not covered within its guidance document, and that requirements established by the Federal Communications Commission may be applicable.
In September 2012, the FCC posted its final rules for MBANs, which will consist of wearable monitors that send non-voice data to nearby hubs and will free patients from their hospital beds. The FCC is allocating 40 MHz of spectrum in the 2360-2400 MHz band for MBANs, with the 2360-2390 MHz band to be used indoors only, and the 2390-2400 MHz band to accommodate outdoor use.