FDA issued their “Guidance for Industry for Radio Frequency Wireless Technology in Medical Devices” on August 14, 2013. This guidance document highlights and discusses RF wireless technology considerations that should be taken into account to help provide for the safe and effective use of these medical devices. These considerations include selecting wireless technology, quality of service, coexistence, security, and electromagnetic compatibility.
FDA’s guidance documents, including this document do not establish legally enforceable responsibilities. However, this guidance document does describe the agency’s current thinking on a topic and should be viewed only as recommendations unless specific regulatory or statutory requirement are cited.
The term medical devices referred to in this document includes all medical devices that incorporate RF wireless technology such as Wireless Medical Telemetry Service, Medical Device Radiocommunication Service including the former Medical Implant Communications Service as well as Medical Micropower Network, and Medical Body Area Networks, cellular communication chipsets, and RFID products.
The recommendations for RF wireless medical devices includes those that are implanted, worn on the body or other external wireless medical devices intended for use in hospitals, homes, clinics, clinical laboratories, and blood establishments. Both wireless induction-based devices and radiated RF technology device systems are within the scope of the guidance. The use of RF energy to generate images of the internal structures of the body such as MRI systems is outside the scope of this document.
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GjuidanceDocuments/ucm077210.htm has more information. For questions, contact Donald Witters (CDERH) at 301-796-2483 or by email at Donald.witters@fda.hhs.gov.