The FCC has proposed a new experimental radio license that is intended to facilitate development of wireless medical devices. The medical program experimental license would allow institutions to conduct ongoing research and experimentation related to development of new medical devices that utilize wireless technology under a single FCC authorization. The license could streamline product development by eliminating the need to obtain multiple experimental licenses to develop and evaluate wireless medical devices. By establishing the new license, the FCC hopes to cultivate test beds for medical device innovation that will attract research and facilitate commercialization of new wireless medical devices.
The proposal was announced in a Notice of Proposed Rulemaking published by the FCC on November 30, 2010. “Promoting Expanded Opportunities for Radio Experimentation and Market Trials under Part 5 of the Commission's Rules and Streamlining Other Related Rules,” FCC 10-197, http://tinyurl.com/4hazob8. In the publication, the FCC also proposed two additional licenses intended to foster research and innovation: a research program license and an innovation zone program license.
A licensee under the proposed medical program license would enjoy a blanket experimental use authorization that would offer significant flexibility over the types of tests and the range of products that could be evaluated. The license would be available to institutions that create and manage medical device test beds, such as research and teaching hospitals and other institutions. Device manufacturers, developers, and other researchers could partner with the licensed institutions to conduct testing under the institution's license. By channeling licensing through institutions, the FCC looks to balance freedom of development with management of logistical and certain technical aspects of experimental radio testing activities.
The license would cover activities related to the evaluation of wireless devices for therapeutic, monitoring, diagnostic, or RF ablation purposes that have not been submitted for equipment certification. Developers of wireless medical devices teamed with licensed institutions would have broad ability to test and assess operational readiness of experimental and new devices under a single license without obtaining FCC pre-approval for evaluations. For example, devices tested, radio frequency bands used, and technical characteristics of evaluations may be established as appropriate without prior FCC approval.
The proposed license would have a five-year duration that could be renewed. Licensee institutions would be required to comply with certain FCC reporting requirements describing testing that had been conducted. Although reports would be made available to the medical community in order to foster technical advances, confidentiality over proprietary technology and information would be maintained. Under the proposal, licensees would submit an annual activity report and submit a summary report of findings to the FCC within 30 days of completing a test.
Because the proposed license is intended to facilitate innovation, testing would be limited to evaluation of new devices. Accordingly, the existing experimental radio license program will continue to be available to support other experimental activities as well as licensees that do not qualify for the proposed license. To further facilitate innovation of wireless medical devices, the FCC also is proposing to simplify existing rules and expand opportunities for market trials of wireless devices such as streamlining investigational device exemptions (IDE) for wireless medical devices evaluations involving patients.
The wireless medical device field is viewed by the FCC as ripe for significant innovation that could lead to economic growth. The medical program experimental license is intended to accelerate innovation in this area and shorten the time needed to bring new wireless devices to market.