FCC Makes Some, but not all, Requested Changes to Experimental Radio Service Rules

licensees and compliance testing licensees to use the bands exclusively allocated to the passive services in limited circumstances. The FCC also decided some cost recovery is allowed for the testing and operation of experimental medical devices in clinical medical trials that take place under the agency’s market trial rules, and added a definition of “emergency notification providers” to the rules to clarify that all participants in the Emergency Alert System (EAS) are such providers. But the agency declined to expand the eligibility for medical testing licenses. Medical device maker Medtronic had asked the FCC to expand the definition beyond healthcare facilities of who's eligible for a medical testing license. “In particular, Medtronic argues that expanding the eligibility to device manufacturers would level the playing field under the rules since the line between device manufacturers and health care facilities is blurring as healthcare providers are among those who develop medical devices,” the agency said. The FCC said it considered this request but found “good reason” to deny it. “The Commission limited the eligibility and scope of a medical testing license to hospitals and health care institutions to address their particular needs in conducting multiple clinical trials, both within their institutions and at defined geographic areas beyond their facilities that will be monitored by the licensee,” the agency said. “The Commission’s primary concern in authorizing experimentation with [radio frequency] RF devices is to ensure that the devices do not cause harmful interference to authorized users of the spectrum and that the devices do not enter into commerce prior to Commission certification,” the agency said. “A Part 5 licensee is the party that we hold responsible for the proper operation of the experimental RF devices to avoid harmful interference to authorized spectrum users and to take corrective action as necessary.” Expanding eligibility to hold a license could “create confusion in determining who is responsible for the proper operation of the experimental RF devices to avoid harmful interference to other spectrum users and to take corrective action as necessary,” the FCC said. Companies like Medtronic still have other options, including obtaining a conventional experimental license to conduct a test, the agency said. Medtronic asked the FCC to change the rules in a 2013 petition. In restricting who's eligible, the FCC is out of sync with Food and Drug Administration rules, the company said. “By barring a significant portion of the medical community involved in clinical trials from obtaining medical testing licenses, the ERS Order reflects a misunderstanding of the process of medical device development, arbitrarily imposes additional costs and burdens on entities that sponsor or conduct clinical trials but do not meet the Commission’s narrow definition of ‘health care facility,’ and discourages the very innovation it seeks to encourage,” Medtronic said at the time.