This week the Federal Communications Commission (FCC) announced a proposal to create a new medical program experimental radio license that would help create “cutting-edge test-bed facilities, where manufacturers and developers could try out new wireless medical technologies and assess operational readiness.”
The FCC said that the idea for such a program arose during its meeting with the Food and Drug Administration (FDA) this past summer.
“Researchers, educators and practitioners could partner with Veterans Affairs facilities and leading research and teaching hospitals, for example, to speed the development of new ideas and innovations,” the FCC wrote in its proposal. “A medical experimental authorization would allow for the testing and operation of new medical devices that use wireless telecommunications technology for therapeutic, monitoring, or diagnostic purposes that have not yet been submitted for equipment certification, or for devices that use RF for ablation, so long as the equipment is designed to meet the FCC’s technical rules.”
The FCC said it would work with the FDA to implement such a program, especially when researchers seek to test new devices with patient participation. On that note, the FCC noted that “this program is not intended to replace the FDA’s existing oversight and review programs.”
“The proposals herein are intended to shorten the time it takes manufacturers to develop devices and systems by streamlining the approval process – in particular, the process by which medical equipment must be approved under the [FCC's] equipment authorization procedures,” the proposal reads. “Consequently, this arrangement could lead to quicker development of medical breakthroughs that will help all Americans, including the brave men and women who were wounded in defense of our Nation and who deserve our best efforts to facilitate the creation of tools and services that could ease their transition to civilian life.”
The FCC specifically describes two types of medical devices that the proposal focuses on: “Radio-frequency (RF) wireless medical devices which are medical devices that include at least one function that is implemented using RF wireless communications; examples of functions that may be implemented wirelessly include data transfer, device control, programming, power transmission, remote sensing and monitoring, and identification…. and 2) Medical devices that use RF for ablation (i.e., removal of a part of biological tissue usually by surgery. RF ablation can very precisely deliver RF energy to kill specific cells, such as cancer cells, without causing damage to nearby healthy cells).”
This proposal from the FCC calls to mind the Centers for Medicare and Medicaid Services (CMS) recently launched Innovation Center, which will “act as testing grounds for new practices, yielding innovative ideas and lessons” that will (hopefully) lead to reimbursement for some wireless health services.
Read the FCC’s proposal in its entirety here (PDF)