Wireless Device Guidance Focuses on Interference, Risk Mitigation

Developers of wireless medical devices need to consider whether their products will play well with other devices sharing the same radio band, an FDA guidance says. The document outlines steps to ensure wireless devices transmit data correctly, securely and in a timely manner. In issuing the guidance, the FDA cites the growing use of medical devices in electromagnetic environments that contain multiple sources of radiofrequency (RF) energy. This increases the likelihood that emissions from one device could interfere with the functioning of another, the agency says.
Devices & Diagnostics Letter