FDA Issues Guidance for Integration of RF Wireless Technology in Medical Devices

Due to rapid growth in medical devices that incorporate RF wireless technology, on August 14 the Food and Drug Administration (FDA) released final guidance for integrating radio frequency (RF) wireless technology in medical

MET Engineer Doing a Medical Product Evaluation

devices.  The guidance is recommended, but not mandatory.

FDA said its recommendations cover devices that are implanted or worn on the body, and others intended for use in locations such as hospitals and clinical laboratories.

The guidance discusses issues that may affect the safe and effective use of medical devices that incorporate RF wireless technology, including electromagnetic compatibility (EMC).

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.

FDA says these issues should be considered for all medical devices that incorporate RF wireless technology, such as Wireless Medical Telemetry Service (WMTS); Medical Device Radiocommunication Service (MedRadio) as well as Medical Micropower Network (MNN) and Medical Body Area Network (MBAN); cellular communication chipsets; and RF identification (RFID) products.

FDA recommends that EMC be an integral part of the development, design, testing, and performance for RF wireless medical devices. Beyond FCC requirements, FDA recommends using risk analysis to identify any potential issues associated with EMC and determining risk acceptability criteria based on information about the device and its intended use, including foreseeable misuse, sources of environmental EMD (e.g., radio transmitters, computer RF wireless equipment), and the potential for RF emissions to affect other devices.

IEC 60601-1-2 is a FDA-recognized consensus standard for EMC, but it does not adequately address whether the wireless communications will operate properly in the presence of in-band EMD (e.g., other RF emissions overlapping the frequency band utilized by the medical device wireless signals). Therefore, the medical device’s wireless communication(s) should be actively transmitting while testing for susceptibility during all EMC immunity testing.

EMC considerations for active implantable medical devices are covered under documents such as the ISO 14708-1 standard (see Appendix B).

FDA worked closely with the Federal Communications Commission (FCC) to develop this guidance.

MET Labs teamed with FDA on a voluntary Program to Test Medical Devices for RFID Interference.  Find out more about the Program. 

MET also tests medical equipment for product safety to 60601-1 3rd edition, for EMC compliance to 60601-1-2, and does performance testing for leading medical device manufacturers.

MET’s Annual Global Compliance Seminar in September will include a session on Electrical Medical Equipment Approvals for EU.  Register here.

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