By Nathaniel Weixel
The Food and Drug Administration Aug. 13 released final guidance for industry and FDA staff on incorporating and integrating radio frequency (RF) wireless technology in medical devices.
In a Federal Register notice announcing the guidance and set for Aug. 14 publication, FDA said its recommendations cover 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 discusses issues that may affect the safe and effective use of medical devices that incorporate RF wireless technology, including selection of wireless technology, quality of service, coexistence, security, and electromagnetic compatibility. The guidance also provides recommendations for information to be included in FDA premarket submissions for such devices, FDA said.
According to the guidance, titled Radio Frequency Wireless Technology in Medical Devices, there has been rapid growth in medical devices that incorporate RF wireless 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,” FDA said in the guidance.
The use and deployment of RF wireless technology in and around medical devices is an increasing concern because the electromagnetic environments where medical devices are used might contain many sources of RF energy, and the RF wireless emissions from one product or device could potentially affect the function of another, the agency said. The guidance recommends that manufacturers address the potential issues that relate to the incorporation of RF wireless technology that may affect the safe and effective use of medical devices.
The draft guidance was issued in January 2007 (72 Fed. Reg. 137), and addressed “design, development, and evaluation of radio frequency wireless technology in medical devices.”
In an Aug. 13 blog posting, FDA senior policy adviser Bakul Patel said the guidance “reflects FDA's ongoing commitment to the practice of regulatory science; that is, the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products.”
In this instance, Patel said FDA worked closely with the Federal Communications Commission (FCC), which in 2009 was charged by Congress to develop a National Broadband Plan to ensure every American has access to wireless technology and to delineate the respective areas of expertise and jurisdiction between the agencies.
“Our goal is to help industry develop a range of innovative, safe, and effective medical devices that incorporate wireless technology, which can, in turn, help reduce health care costs, enhance quality, and benefit patients and providers alike,” Patel said in the blog posting.
The device guidance said wireless safety was a priority, and referred manufacturers to a June draft guidance on cybersecurity. In that draft, FDA provided recommendations on cybersecurity management measures for manufacturers preparing premarket submissions for medical devices (see previous article).
The final guidance also called for RF-specific safeguards.
“While most wireless technologies have encryption schemes available, wireless encryption might need to be enabled and assessed for adequacy for the medical device's intended use. In addition, the security measures should be well coordinated among the medical device components, accessories, and system, and as needed, with a host wireless network,” FDA said in the final guidance.
Similar to the draft guidance, the RF final guidance noted that wireless devices must be able to coexist with each other. According to the final guidance, designers and manufacturers of wireless medical devices “should consider the ability of their devices to function properly in the intended use environments where other RF wireless technologies will likely be located. In the design, testing, and use of wireless medical devices, the correct, timely, and secure transmission of medical data and information is important for the safe and effective use of both wired and wireless medical devices and device systems.”
Since it is possible for an electromagnetic disturbance (EMD) to affect important medical device functions, mitigation measures for some risks could aid the device operator in recognizing a hazardous situation and taking action to prevent harm, FDA said in the guidance.
The guidance cautioned manufacturers to take into account other risks, such as:
• poorly characterized or poorly utilized wireless systems (e.g., wireless networks);
• lost, corrupted, or time-delayed transmissions, and degradations in wireless transmissions;
• lack or compromise of wireless security; and
• potential misuse of a wireless medical device because of lack of or inadequate instructions for use.
The guidance also describes what sponsors should incorporate into a premarket approval application for RF devices.
The guidance said manufacturers will need to consider the quality of service necessary to ensure proper functioning in the device, security of wireless signals, maintenance of the device, and whether the device will be able to coexist and operate effectively with other devices in a shared environment.
FDA also noted the need for test data summaries and proper labeling procedures.
The guidance is at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm077272.pdf.
The FDA blog posting is at http://blogs.fda.gov/fdavoice/index.php/2013/08/cutting-the-wires-fda-provides-industry-guidance/.
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