Operation in the MedRadio service is permitted by rule and without an individual license issued by the FCC. Duly authorized health care professionals are permitted to operate MedRadio transmitters. Persons may also operate MedRadio transmitters to the extent the transmitters are incorporated into implanted or body-worn medical devices that are used by the person at the direction of a duly authorized health care professional; this includes medical devices that have been implanted in that person or placed on the body of that person by or under the direction of a duly authorized health care professional. Manufacturers of medical devices that include MedRadio transmitters, and their representatives, are authorized to operate transmitters in this service for the purpose of demonstrating such equipment to duly authorized health care professionals. No entity that is a foreign government or which is acting in its capacity as a representative of a foreign government is eligible to operate a MedRadio transmitter. The term “duly authorized health care professional” means a physician or other individual authorized under state or federal law to provide health care services. Operations that comply with the requirements of this part may be conducted under manual or automatic control.

MedRadio operation is authorized anywhere CB station operation is authorized under § 95.405.

A station is not required to transmit a station identification announcement.

Any non-implanted MedRadio transmitter must be made available for inspection upon request by an authorized FCC representative. Persons operating implanted or body-worn MedRadio transmitters shall cooperate reasonably with duly authorized FCC representatives in the resolution of interference.

(a) Except for the purposes of testing and for demonstrations to health care professionals, MedRadio programmer/control transmitters may transmit only non-voice data containing operational, diagnostic and therapeutic information associated with a medical implant device or medical body-worn device that has been implanted or placed on the person by or under the direction of a duly authorized health care professional.

(b) Except as provided in § 95.628(b) no MedRadio implant or body-worn transmitter shall transmit except in response to a transmission from a MedRadio programmer/control transmitter or in response to a non-radio frequency actuation signal generated by a device external to the body with respect to which the MedRadio implant or body-worn transmitter is used.

(c) MedRadio programmer/control transmitters may be interconnected with other telecommunications systems including the public switched telephone network.

(d) For the purpose of facilitating MedRadio system operation during a MedRadio communications session, as defined in § 95.628, MedRadio transmitters may transmit in accordance with the provisions of § 95.628(a) for no more than 5 seconds without the communications of data; MedRadio transmitters may transmit in accordance with the provisions of § 95.628(b)(2) and (b)(3) for no more than 3.6 seconds in total within a one hour time period; and MedRadio transmitters may transmit in accordance with the provisions of § 95.628(b)(4) for no more than 360 milliseconds in total within a one hour time period.

(e) MedRadio programmer/control transmitters may not be used to relay information to a receiver that is not included with a medical implant or medical body-worn device. Wireless retransmission of information intended to be transmitted by a MedRadio programmer/control transmitter or information received from a medical implant or medical body-worn transmitter shall be performed using other radio services that operate in spectrum outside of the MedRadio band.

(a) The channels authorized for MedRadio operation by this part of the FCC Rules are available on a shared basis only and will not be assigned for the exclusive use of any entity.

(b) To reduce interference and make the most effective use of the authorized facilities, MedRadio transmitters must share the spectrum in accordance with § 95.628.

(c) MedRadio operation is subject to the condition that no harmful interference is caused to stations operating in the 400.150-406.000 MHz band in the Meteorological Aids, Meteorological Satellite, or Earth Exploration Satellite Services. MedRadio stations must accept any interference from stations operating in the 400.150-406.000 MHz band in the Meteorological Aids, Meterological Satellite, or Earth Exploration Satellite Services.

No antenna for a MedRadio transmitter shall be configured for permanent outdoor use. In addition, any MedRadio antenna used outdoors shall not be affixed to any structure for which the height to the tip of the antenna will exceed three (3) meters (9.8 feet) above ground.

Manufacturers of MedRadio transmitters must include with each transmitting device the following statement:

“This transmitter is authorized by rule under the Medical Device Radiocommunication Service (in part 95 of the FCC Rules) and must not cause harmful interference to stations operating in the 400.150-406.000 MHz band in the Meteorological Aids (i.e., transmitters and receivers used to communicate weather data), the Meteorological Satellite, or the Earth Exploration Satellite Services and must accept interference that may be caused by such stations, including interference that may cause undesired operation. This transmitter shall be used only in accordance with the FCC Rules governing the Medical Device Radiocommunication Service. Analog and digital voice communications are prohibited. Although this transmitter has been approved by the Federal Communications Commission, there is no guarantee that it will not receive interference or that any particular transmission from this transmitter will be free from interference.”

(a) MedRadio programmer/control transmitters shall be labeled as provided in part 2 of this chapter and shall bear the following statement in a conspicuous location on the device:

“This device may not interfere with stations operating in the 400.150-406.000 MHz band in the Meteorological Aids, Meteorological Satellite, and Earth Exploration Satellite Services and must accept any interference received, including interference that may cause undesired operation.”

The statement may be placed in the instruction manual for the transmitter where it is not feasible to place the statement on the device.

(b) Where a MedRadio programmer/control transmitter is constructed in two or more sections connected by wire and marketed together, the statement specified in this section is required to be affixed only to the main control unit.

(c) MedRadio transmitters shall be identified with a serial number. The FCC ID number associated with a medical implant transmitter and the information required by § 2.925 of this chapter may be placed in the instruction manual for the transmitter and on the shipping container for the transmitter, in lieu of being placed directly on the transmitter.

Transmitters intended for operation in the MedRadio Service may be marketed and sold only for the permissible communications described in § 95.1209.

MedRadio medical implant or medical body-worn transmitters (as defined in appendix 1 to subpart E of part 95 of this chapter) are subject to the radiofrequency radiation exposure requirements specified in §§ 1.1307 and 2.1093 of this chapter, as appropriate. Applications for equipment authorization of implant devices operating under this section must contain a finite difference time domain (FDTD) computational modeling report showing compliance with these provisions for fundamental emissions. The Commission retains the discretion to request the submission of specific absorption rate measurement data.