The Federal Communications Commission (“FCC”) recently released a Second Report and Order (“R&O”), which for the first time enables Program Experimental Licensees (“Program Licensees”) access to restricted frequency bands to conduct testing and experiments on radiofrequency (“RF”)-based medical devices. This ruling is critical for many reasons, not the least of which is that the restricted frequencies include the 401-406 MHz “MedRadio” band, frequently used by manufacturers of implanted and body-worn medical devices.
In 2015, the FCC updated its experimental licensing program by establishing certain categories of licenses, including: (a) “Medical Testing Licenses,” authorizing health care facilities to conduct clinical trials and other experiments on RF medical equipment; and (b) “Program Experimental Licenses,” which authorize qualified colleges and universities, research labs, health care institutions, and equipment manufacturers to conduct testing and market trials of RF devices. The FCC previously permitted Medical Testing Licensees access to the restricted frequencies, but not Program Licensees.
Based on comments submitted by a large medical technology company, arguing that Program Licensees are unfairly disadvantaged by not having access to the restricted bands, the FCC decided to grant those licensees the same access as it grants Medical Testing Licensees. The FCC reasoned that because Medical Testing Licensees are authorized to conduct market trials as well as clinical testing using the restricted bands, it should allow Program Licensees to utilize those bands for their own research and experimental purposes. The FCC codified the R&O by amending Section 5.303 of its rules
The revised FCC rule significantly expands the flexibility of all qualified entities to conduct a wide range of RF-based medical experiments, regardless of whether they qualify as a Medical Testing Licensee. As the FCC’s experimental licensing program is very often a critical component of RF equipment designers’ pre-marketing stratagem, this expansion of experimental authorization is quite significant.
If you would like additional Information about this proceeding or other matters pertaining to the FCC’s experimental licensing program; or to obtain a hard copy of our comprehensive Global RF Equipment Regulatory Compliance Guide, please contact IoT Attorney Ronald E. Quirk, Jr. at (703) 714-1305 or firstname.lastname@example.org.