On August 14, 2013, the Food and Drug Administration released the final guidance titled “Radio Frequency Wireless Technology in Medical Devices” for incorporating and integrating RF wireless technology in medical devices.
The guidance covers devices that are worn on the body or implanted and others that are intended for use in locations such as hospitals, clinics and clinical laboratories. The draft guidance was originally issued in January 2007 (72 Fed. Reg. 137).
The guidance discusses issues for the effective use of medical devices that incorporate RF wireless technology including how to select wireless technology, the quality of service, coexistence, security and electromagnetic compatibility. Manufacturers of medical devices are recommended to address potential issues related to the incorporation of RF wireless technology that may affect the safe and effective use of these type of devices.