![]() ![]() ![]() FCC: Connect2HealthFCC - Wireless Health and Medical Devices BackgroundĪll types of wireless technology face challenges coexisting in the same space. ![]() FCC: Connect2Health FCC - charting the broadband future of health care.FCC: Rules and regulations for Title 47 (Telecommunications).FCC: Equipment Authorization Approval Guide.Food and Drug Administration, Federal Communications Commissionįor information on applicable FCC requirements for wireless medical devices, please refer to the following links: Joint Statement on Wireless Medical Devices - U.S.The FDA’s policies on wireless medical devices are coordinated with the FCC and provide medical device manufacturers with more predictability and a better understanding of regulatory requirements for medical devices that utilize these technologies. The Federal Communications Commission (FCC) oversees the use of the public Radio Frequency (RF) spectrum within which RF wireless technologies operate. As RF wireless technology continues to evolve, this technology will increasingly be incorporated into the design of medical devices.Įxamples of areas that utilize RF wireless technology include:Ĭoordination with Federal Communications Commission (FCC) Examples of functions that can utilize wireless technology include controlling and programming a medical device, monitoring patients remotely, or transferring patient data from the medical device to another platform such as a cell phone. Radio frequency (RF) wireless medical devices perform at least one function that utilizes wireless RF communication such as Wi-Fi, Bluetooth, and cellular/mobile phone to support health care delivery. FDA Recognized Standards Related to Wireless Medical Devices.Information for RF Wireless Developers and Manufacturers.Information for Health Care Facilities: Risk Management.Coordination with Federal Communications Commission (FCC). ![]()
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