In Medical Devices
Guidance for Industry and Food and Drug Administration Staff
This FDA Document Issued on: August 13, 2013
FDA has developed this guidance document 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. There has been rapid growth in medical devices that incorporate RF wireless technology due to the expansion of this technology. With the 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 help provide for the safe and effective use of these medical devices. This guidance highlights and discusses RF wireless technology considerations that can have an effect on the safe and effective use of medical devices. These considerations include the selection of wireless technology, quality of service, coexistence, security, and electromagnetic compatibility (EMC). Consideration of these areas can help provide reasonable assurance of safety and effectiveness for medical devices that incorporate RF wireless technology, and are supplementary to other device-specific guidances or guidelines.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
This guidance document addresses considerations that may affect the safe and effective use of medical devices that incorporate RF wireless technology (also referred to as wireless medical devices), including the selection of wireless technology, quality of service, coexistence, security, and EMC. These issues should be considered for all medical devices that incorporate RF wireless technology, such as Wireless Medical Telemetry Service (WMTS); Medical Device Radiocommunication Service (MedRadio) (including the former Medical Implant Communications Service (MICS)) as well as Medical Micropower Network (MNN) and Medical Body Area Network (MBAN); cellular communication chipsets; and RF identification (RFID) products. Such RF wireless technologies operate under a grant of certification and/or issuance of a license from the Federal Communications Commission (FCC).
This guidance also provides recommendations for information to be included in FDA premarket submissions for medical devices and device systems that incorporate RF wireless technology. Requirements by other agencies are not covered within this document, although we note that requirements established by the FCC may be applicable.
The recommendations in this guidance are intended for RF wireless medical devices including 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 this guidance. The use of RF energy to generate images of the internal structures of the body such as in magnetic resonance imaging systems is outside the scope of this guidance document.
See Appendix A for a glossary of key terms associated with RF wireless technology and wireless medical devices that have been adapted from the IEC 60050-161 International Electrotechnical Vocabulary (IEV) and other sources.
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