Business · 03/01/2007

FDA Releases Draft Guidance on Radio-Frequency Wireless Technology in Medical Devices

The Food and Drug Administration (FDA) has released a draft guidance document addressing the safe and effective use of radio frequency (RF) wireless technology in medical devices, including wireless coexistence, performance, data integrity, security, and electromagnetic compatibility (EMC). The guidance is intended to help industry and FDA staff prepare premarket submissions and ensure compliance with regulatory requirements.