The FCC's Office of Engineering and Technology (OET) conducts many activities relating to wireless medical devices, including equipment authorization (for products such as smartphones, car door remote controls, Wi-Fi devices, baby monitors, and personal computers); testing for radio frequency safety; and regulation of radio spectrum.
OET has a long history of working to enable health and medical devices. Some of its more recent accomplishments include:
MedRadio (Medical Device Radiocommunications Service): In the course of two rulemaking proceedings, the Commission allocated spectrum and adopted technical rules for innovative new body-worn and implanted medical radio devices that can provide a variety of diagnostic and therapeutic functions from diabetes and heart monitors to pacemakers and cardiofribrilators.
Medical Body Area Networks (MBANs): In 2012, the FCC released an Order to allocate spectrum for Medical Body Area Networks (MBANs), making the U.S. the first country in the world to make spectrum available for this specific usage. MBANs are networks of wireless sensors, often no bigger than a Band-Aid, which can transmit data on a patient's vital health indicators to their doctor or hospital. For more information, see the MBANs Fact Sheet and a listing of Frequency Bands for Medical Devices.
Medical Micropower Networks (MMNs): In 2011, the FCC adopted rules to enable a new generation of wireless medical devices that can be used to restore functions to paralyzed limbs. MMNs are ultra-low power wideband networks consisting of transmitters implanted in the body that take the place of damaged nerves, restoring sensation and mobility.
Retinal Implants: In November 2011, OET granted a waiver of the Commission's rules to Second Sight Medical Products, Inc. to allow it to obtain FCC certification for and market its Argus II Retinal Prosthesis System which is a medical implant system designed to treat profoundly blind people suffering from advanced retinal degenerative diseases. For more information, see the waiver (https://docs.fcc.gov/public/attachments/DA-11-1951A1.pdf)
Experimental Licensing Program: In May 2012, the FCC announced a plan to cut red tape and increase spectrum flexibility for testing new wireless health innovations, to speed new wireless health technologies to market. The new experimental licensing regime will create more flexibility and streamlined processes for testing new wireless medical devices.
FCC-FDA Memorandum of Understanding: In 2010, the FCC entered into an unprecedented partnership with the Food and Drug Administration, working together to ensure that communications-related medical innovations can swiftly and safely be brought to market. In June 2012, the FCC issued a letter in response to an inquiry from Reps. Walden, Bilbray, Blackburn, Burgess, Gingrey, and Pitts regarding wireless medical devices and the FCC's partnership with FDA, providing a comprehensive overview of activities that the two agencies have undertaken since enacting the MOU in 2010.
Frequency Bands for Medical Devices
- Medical Radio Communications Service (MedRadio)
- Authorized under Part 95, subpart I
- Frequency Band – General Usage: medical devices for transmitting data containing operational, diagnostic and therapeutic information associated with a medical implant device or medical body worn devices
- - 401-406 MHz
- Frequency Bands for Specific Applications:
- Medical Micropower Networks (MMNs): wireless medical devices that can be used to restore functions to paralyzed limbs
- - 413-419 MHz
- - 426-432 MHz
- - 438-444 MHz
- - 451-457 MHz
- Medical Body Area Networks (MBANs): networks of body-worn wireless sensors that transmit patient data to a health care provider
- - 2360-2400 MHz
- Please refer to the rules to determine specific technical and operational rules for each MedRadio frequency band
- Wireless Medical Telemetry Service (WMTS): a short distance data communication service for transmitting patient medical information to a central monitoring location in a medical facility
- Authorized under Part 95, subpart H
- Frequency Bands:
- - 608-614 MHz
- - 1395-1400 MHz
- - 1427-1429.5 MHz(location specific)
- - 1429-1431.5 MHz (location specific)
- Please refer to the rules to determine specific technical and operational rules for each MedRadio frequency band
- Medical devices may also operate under the rules for unlicensed devices under Part 15 in any frequency band available under that Part.