A new regulation published by the Federal Communications Commission (FCC) would serve to streamline the Experimental Radio Service (ERS), a block of radio spectrum meant to promote innovation, including its medical testing license, now used in some medical device products.
Background
The ERS is basically a set of rules that "prescribe the manner in which the radio spectrum may be made available to manufacturers, inventors, entrepreneurs and students to experiment with new radio technologies, equipment designs, characteristics of radio wave propagation, or service concepts related to the use of the radio spectrum."
The rule is intended to promote innovation by encouraging a flexible approach that permits innovators to use a slice of spectrum, but under a fairly serious stipulation: The spectrum is not shielded from other frequencies, but may not interfere with established frequencies either.
That's useful for medical devices, which often operate on low-power, short-range frequencies for communicating with one another. For example, FCC recently issued regulations regarding a specific slice of spectrum dedicated to networked medical devices, known as Medical Body Area Networks (MBAN), which is built upon the Medical Device Radiocommunication (MedRadio) network. Users of that spectrum will not be required to be licensed with FCC based on the agency's understanding that interference from and between devices in the network will be minimal, though the companies will need to register.
As explained in FCC's Federal Register document on the rule, the commission had moved in 2010 to implement changes that it hopes will "provide additional flexibility to innovators so that they can more quickly transform their ideas to fully functional new products and services that meet consumer needs."
"Specifically, the Commission proposed to create a new program experimental license [under the National Broadband Plan] to provide greater flexibility than the conventional experimental license to allow experimenters to alter the course of their tests, if needed, without having to request specific permission from the Commission."
The Rule
Under FCC's new rule, the agency will grant three types of licenses, of which one is a "medical testing license" it says will allow health care facilities like hospitals to "undertake clinical trials of cutting-edge wireless medical technologies."
These testing opportunities, which FCC also refers to as "market trials," get complicated when interacting with medical devices intended for human patients under an approved investigational device exemption (IDE) application. Such applications are used by a device sponsor to initiate clinical testing-the very same area FCC's regulation wishes to oversee in part.
FCC acknowledged that dealing with two separate regulatory agencies in this regard had the potential to become overly complicated, and thus explained that it is exploring a streamlined approach along with FDA to "ensure that patient safety is considered" and allow products to get approval more quickly.
"The new program is not intended to replace the FDA's existing oversight and review programs," FCC emphasized.
Clinical vs. Nonclinical
Research that does not involve human subjects will be covered by a single program experimental license now meant for more basic research, while clinical trials will be covered by a medical testing license.
"The Commission does not believe that the issuance of further guidelines about the Commission's and FDA's respective roles in the application, review, and approval processes should serve as a precondition to or otherwise keep us from adopting the proposed rules," FCC said. "Licensees seeking to test medical devices who have specific questions … should continue to raise these matters directly with staff at the respective agencies."
As a basic rule, FCC said it must caution medical device manufacturers to obtain FDA approval for an IDE before conducting human testing involving the ERS, and will need to satisfy both agencies' requirements.
"Thus, medical testing licensees must consider that a license grant by the Commission may not by itself be sufficient to begin testing," it added. "If the Commission determines that FDA requirements have not been met for a particular device that is the subject of an experiment, it may take action up to and including termination of the experimental license."
The license application to FCC will be used to assess "patient compatibility and use, as well as operational, interference, and RF immunity issues in real world situations," it said. The healthcare facilities will be assessed by FCC for the management of radio frequencies "so as not to cause harmful interference to any authorized spectrum user," regulators added.
Licenses will be valid for five years, after which time they will need to be renewed. One license will be able to be used for multiple medical devices involved in clinical trials.
You can read the full regulation here.
FCC: Radio Experimentation and Market Trials-Streamlining Rules