May 21 2009
On March 20, 2009 the FCC adopted rules for the creation of the Medical Device Radiocommunication Service (MedRadio). (ET Docket No. 06-135). MedRadio will replace the existing Medical Implant Communications Service (MICS) formed in 1999. It remains under Part 95I and maintains most of the technical rules of the MICS service. MedRadio keeps the spectrum previously allocated for MICS (402-405 MHz), but adds additional adjacent spectrum (401-402 MHz and 405-406 MHz).
MedRadio is based upon the existing MICS rules. It includes modified spectrum sharing requirements in the new wing bands (401-402 MHz and 405-406 MHz). Implants that are LBT-enabled can be used across the entire 401-406 MHz band. Body-worn devices that are LBT-enabled will be, with one exception, permitted to operate only in the new wing bands at 401-402 MHz and 405-406 MHz. Temporary body-worn transmitters can be used in the 402-405 MHz core band solely during a limited patient evaluation period in order to determine the suitability of a fully implanted device, provided that they fully comply with all other MedRadio rules applicable to the band.
Both implant and body-worn transmitters using non-LBT spectrum access methods (with reduced EIRP and duty cycle limits) will also be permitted in the new wing bands. In the core band, non-LBT operation will be limited to medical implant devices operating with a total channel emission bandwidth not exceeding 300 kilohertz centered at 403.65 MHz. The rules are generally harmonized with EU standards and other international requirements.
The FCC encourages the continuing use of the legacy MICS core band predominantly for life-critical applications, such as pacemakers and defibrillators. MedRadio is not a legal requirement until 90 days after publication in the Federal Register.