The Federal Communications Commission recently proposed a new experimental radio license intended to facilitate development of wireless medical devices. Under the proposed medical program experimental license, qualifying institutions would be permitted through a single FCC authorization to conduct ongoing research and experimentation related to the development of new medical devices that utilize wireless technology. The proposed license aims to eliminate the need to obtain multiple experimental licenses for developing and evaluating wireless medical devices. By establishing the new license, the FCC hopes to foster creation of test beds for medical device innovation that will attract research funding and facilitate commercialization of innovative wireless medical devices.

The proposed experimental license was developed in collaboration with FDA and the American Society for Healthcare Engineering. The details of the proposal were announced in a Notice of Proposed Rulemaking published by the FCC on November 30, 2010.1 In the notice, the FCC also proposed creation of two additional experimental radio licenses—the research program license and the innovation zone program license. In addition, the commission presented further proposals to facilitate market trials of new wireless products and streamline existing experimental rules.

FCC Waives Preapproval

As presently proposed, the medical program experimental license would be available to research hospitals, teaching hospitals, Veterans Affairs facilities, and other leading institutions. The FCC has proposed that the license have an initial duration of five years and be renewable thereafter. The license would provide wireless device manufacturers and developers who are teamed with licensed institutions the broad ability to test and assess operational readiness of new devices under a single license without obtaining FCC preapproval. The FCC’s existing experimental use regime supports discrete research projects, requires detailed documentation prior to approval, and restricts how experiments can be modified once authorization is granted. The proposed license, however, is a blanket authorization that would provide the licensee with substantial flexibility in controlling what products are tested and how testing is conducted.

Under the new proposal the FCC is striving to strike a balance between the goals of promoting experimentation and managing the technical and logistical aspects of testing carried out at an institution. Thus, institutions that create and manage the new device test beds will be granted the new program experimental licenses, while device manufacturers that may be developing the products and conducting the testing will be excluded from holding licenses. However, the FCC is seeking input on the application process and the qualifications necessary to be granted and hold a license.

As initially proposed, the new license would cover evaluation of devices for therapeutic, monitoring, diagnostic, or RF ablation purposes that have not been submitted for equipment certification. Commissioner Mignon Clyburn observed that the program license could also accelerate innovation in telemedicine, enabling technologies that would support broader collaboration opportunities for physicians. Additionally, FDA and FCC are exploring approaches to streamline issuance of investigational device exemptions to manufacturers performing wireless medical devices evaluations involving patients.

Broad Leeway for Testing

The licensed institution will be given broad leeway in conducting tests. For example, licensees will not be required to seek prior FCC approval to establish the appropriateness of each evaluation for devices tested, radio frequency bands used, and technical characteristics exhibited. The license is intended to facilitate development and evaluation. As a result, testing would be limited in scope to what is necessary and would be conducted under controlled environments to, for example, identify and mitigate potential interference issues before the device enters the market. Accordingly, the FCC will continue to offer conventional experimental radio licenses. The conventional license will remain available to support research, development, and trials of new wireless devices where the developer does not qualify for the new license and for activities that fall outside the scope of the new license. To further promote wireless medical device innovation, the FCC is concurrently proposing to streamline existing rules and expand opportunities for market trials of wireless devices.

Under the new license, the licensed institution would be required to comply with certain reporting requirements. For example, regular reports would be submitted to the FCC regarding test results. These reports to the FCC would be made available to the medical community at large to further foster patient care and development of technical advances in wireless medical devices. However, confidentiality over proprietary technology and information would be maintained. The FCC is presently proposing that the institution submit a report that briefly summarizes the findings to the commission within 30 days of completing a test. Additionally, the institution would file a yearly report of the activity performed under the license.

Seeking Input

The FCC is seeking input on a number of key issues that may define the logistics and potential scope of the new license. Notably, the commission has asked whether developers should be permitted to test devices that do not fully conform to the FCC technical rules. The FCC notes that such testing may have the benefit of empirically demonstrating that the devices could be commercially practical despite having aspects that do not conform to current technical rules. In addition, the commission asks what geographical limitations should be placed on testing carried out under the license. In particular, the FCC wants to know whether tests should include wireless devices worn by or implanted in patients who may leave the institution’s facility or campus.

The FCC views the medical device field as ripe for significant innovation that could lead to economic growth. In addressing the proposal, Commissioner Michael Copps noted that “[n]nowhere is the potential for RF innovation more exciting than in the area of promoting advances in healthcare technology—whether restoring mobility to paralyzed limbs or creating advanced body sensor networks.” By establishing the new license, the FCC hopes to accelerate innovation of new wireless medical technology, while shortening the time needed to bring such devices to market.

Reference
1. “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. Available on Internet: http://www.fcc.gov/Daily_Releases/Daily_Business/2010/db1130/FCC-10-197A....

Michael S. Kramer is an associate with Foley & Lardner LLP (Chicago) and a member of the firm's intellectual property litigation and mechanical and electromechanical technologies practices. He can be reached at 312/832-5190 or mkramer@foley.com.