FDA Finalizes a Guidance on Radio Frequency Wireless Technology for Devices

The Food and Drug Administration Aug. 13 released a 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 that was published Aug. 14 (78 Fed. Reg. 49,529), 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 ...