The Federal Communications Commission issued a final rule April 29 seeking to simplify licensing to the Experimental Radio Service, potentially allowing medical device manufacturers and hospitals easier access to spectrum for conducting clinical trials on wireless devices.

The rule specifically establishes a medical testing license for health care facilities wishing to host human trials for medical devices that employ radiofrequency wireless technology or communication functions for diagnosis, treatment or patient monitoring. The license offers an alternative to conventional FCC research licenses that provide less experimental flexibility.

“[Q]ualified institutions would be permitted to conduct an ongoing program of research and experimentation under a single experimental authorization for a five-year period on a non-interference basis without having to obtain prior authorization for each distinct experiment or series of unrelated experiments,” the Commission writes.

The geographical flexibility of the medical testing license “is necessary to ensure critical functions for many medical devices – such as remote monitoring, device tolerance to potential interference sources, and patient ability to use devices without the benefit of assistance...” – FCC

However, while ultimate authority for the licenses rests with FCC, FDA will still be heavily involved.

“If the Commission determines that FDA requirements [for clinical trials] have not been met for a particular device that is the subject of an experiment,” the rule warns, “it may take action up to and including termination of the experimental license.”

The agency’s reasoning for creating a specific license, separate from its other product licenses, is based on health care’s unique needs. A general program license restricts testing only to a facility under the tester’s control; however, in health care, patients move; additionally, telemedicine and other remote access devices are intended to be used outside of a facility.

“This flexibility is necessary to ensure critical functions for many medical devices – such as remote monitoring, device tolerance to potential interference sources and patient ability to use devices without the benefit of assistance as critical aspects of experiments conducted outside of medical campuses,” the Commission argues. “Health care facilities will specify their intended area of operation when they apply for a medical testing license.”

With that flexibility comes greater responsibility. Hospitals granted a medical testing license will need to be careful to avoid creating harmful interference to other licensed users of the spectrum – the Commission calls any interference “unacceptable.”

“Similarly, medical testing licensees must ensure that their devices are immune to interference affects from authorized services sharing the same bands as their devices,” the rule states.

In order to reduce the incidence of such interference, licensees must register on a website their intention to do an experiment seven days before it starts, and include: a statement describing the experiment; the frequency bands the experiment will use; the power it will be broadcast on; the emission designators; the geographic areas the experiment will run in; the number of units to be used; and a public safety mitigation plan.

The medical testing license would be granted to a facility that is able to take full responsibility for all testing and proper operation of equipment, as well as being responsible for remedying any interference issues that might arise during the trial. Facilities without the necessary expertise for the new license but who are interested in playing host to such experiments may apply to FCC to be an “innovation zone” Such a designation will allow developers and manufacturers, which have separately obtained a more conventional research program license from FCC, to perform clinical testing of the device at the facility.

“This approach may be particularly useful for manufacturers [that] want to test medical or other types of equipment that will be used in a health care setting while it is in the product development stage, but [that] will not be eligible for the medical testing license,” FCC states. Under this arrangement, the manufacturer, rather than the facility, will retain responsibility for the testing and operation of the equipment.

The creation of the medical testing license and innovation zone certification come as FCC has generally deepened its engagement in the issue of giving spectrum access for testing and use of wireless medical devices. Last year, for instance, the Commission granted specific bands of the spectrum to so-called medical body area networks, Band-Aid-sized body sensors connected wirelessly with a nearby patient monitoring hub. (See Also see "Medical Body Area Networks Get Go-Ahead From FCC" - Medtech Insight, 28 May, 2012..)

FCC Simplifies Process To Access Wireless Spectrum For Device Clinical Trials

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