FDA Issues Final Guidance on Radio Frequency Wireless Technology in Medical Devices
Radio frequency wireless technology is becoming increasingly prevalent in our society, including its use in the health care industry and in the development of new medical devices. Today the Food and Drug Administration (FDA) issued the Radio Frequency Wireless Technology in Medical Devices Guidance for Industry and Food and Drug Administration Staff. The FDA is issuing this final guidance to assist industry and FDA staff with the design, testing, deployment, regulatory submission, and maintenance of reliable, safe, and effective radio frequency wireless medical devices and systems.
The FDA also launched a Wireless Medical Devices web page to provide resources and common considerations to promote the safety and effectiveness of radio frequency wireless technology used in medical devices. We believe this information will continue to promote the exciting strides technology has taken to further health care for providers, patients, and consumers.
Thank you for your continued support.
Food and Drug Administration
Center for Devices and Radiological Health