The FDA Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, Center for Biologics Evaluation and Research issued a Guidance document on “Radio Frequency Wireless Technology in Medical Devices” containing recommendations to assist industry and FDA staff in identifying and appropriately addressing specific considerations related to the incorporation and integration of radio frequency (RF) wireless technology in medical devices.
With increasing use of RF wireless medical devices, continuing innovation and advancements in wireless technology, and an increasingly crowded RF environment, RF wireless technology considerations should be taken into account to provide their safe and effective use. Considerations should include the selection of wireless technology, quality of service, coexistence, security, and electromagnetic compatibility.
Designers and manufacturers of wireless medical devices should consider the ability of their devices to function properly in the intended use environments where other RF wireless technologies will likely be located. As part of a comprehensive quality system under 21 CFR Part 820, medical device manufacturers must manage risks including those associated with RF wireless technology, and the FDA recommends that industry carefully consider which device functions should be made wireless and which device functions should employ wired connectivity.
You may submit comments and suggestions at any time for Agency consideration. Submit electronic comments to http://www.regulations.gov .
Consideration should also be given to any limitations or restrictions for proper operation and RF wireless performance (e.g., alarms, back-up functions, alternative modes of operation) when the RF wireless link is lost or corrupted. In addition, worldwide frequency band allocation and international compatibility is critical to the operations of RF wireless devices, and should be considered in the design and development of wireless medical devices.